What does exp. Problematic issues of GMP: Rules for assignment of batch number and expiration date. Recyclable plastic sign

Question 7. Does GMP have clear rules for assigning batch numbers and expiration dates?

Series number

Today, most domestic manufacturers use the standard XXMMYY combination to assign a series number. These are serial number of the series (XX), month (MM) and year (YY) of manufacture of the product, which are sequentially and contiguously recorded. At one time in the USSR, and later in the CIS, various guidelines recommended assigning a series number exactly like this:

“…2.3.9. The series number is indicated by Arabic numerals together, the word "series" is not affixed. The last four digits in the number indicate the month and year of manufacture of the medicinal product. The numbers preceding the last four are the series production number. The dimensions of the figures in height should be no more than 5 mm.

Example: 16140398, where: 0398 - March 1998 - the date of manufacture, 1614 - the production number of the series ... "

A similar scheme is shown in the draft requirements for labeling medicines for the Customs Union:

“… 2.2.10. The release date/manufacturing date is not indicated if the last four digits (six digits) in the batch number indicate the month and year of manufacture of the medicinal product, and the digits preceding the last four (six) are the production batch number ... "

At the same time, in other countries (outside the former USSR) there are much more options for the structure of the series number. Each manufacturer is free to set the code structure (subject to national regulations, if any). According to the logic of GMP, for this it is only necessary to develop an SOP "Rules for assigning a batch number and an expiration date" (or an alternative internal document), in which to determine:

• series number code structure;
• responsibility for assigning a serial number;
• the form of the journal of registration of the series number;
• series number cancellation procedure, etc.

However, whatever the structure of the code, when developing such an SOP, there will always be questions that are quite simple, but have not yet been resolved by domestic regulatory authorities.

As defined by GMP, a "batch number" is a unique* combination of numbers and/or letters that uniquely identifies a batch.

And now the question immediately arises: “Is it possible to call a unique combination of numbers adopted at domestic enterprises?” Probably NO! For example, if the method suggested by the two documents above is used, then the batch number "150213" can be assigned to different drugs, or even to different dosages of the same drug. You may object to this that these are different drugs, and each of them has its own unique series code. I agree, but on the condition that only the joint mention of the series number, name and dosage of the drug makes such a combination of numbers unique. And if at least once you specify the batch number without its other attributes (name, dosage), this can easily lead to confusion of primary data - in equipment operation logs, in QCD records, in warehouse documentation, etc.

Of course, from the various codes used by Western pharmaceutical companies, it is difficult to single out a standard one. Nevertheless, with all the variety of choices, one can notice the same type of solutions. Many companies enter an internal (alphabetic or numeric) product code into the series number. For example, CR150213, or 04150213, where CR or 04 is the internal drug code that takes into account the dosage. These series numbers are truly unique. Often, batch numbers of foreign drugs contain additional letters or numbers. This is due to the fact that GMP requires assigning a batch number already when loading raw materials, while foreign manufacturers often divide a semi-finished product batch into several FPP batches. For example, for separate batches of the same FPP obtained by dividing one batch of a bulk product (in bulk), the numbers CR150213A, CR150213B, CR150213C, etc. are often used, where the letters A, B, C denote the series of FPP intended for different countries (or for different final packing times). Such long (more than 8 characters) batch numbers are inconvenient for engineering staff when setting up a packaging line and for other production personnel (including QC) when maintaining records. Therefore, simpler codes are often used in practice (without indicating the month and / or year of manufacture), for example, CR15A, or 0415B, etc.

Here, legitimate questions arise: “Do consumers need to understand the code structure used by manufacturers to assign a batch number?”, “Does the state need to strive to unify the code for the batch number in the pharmaceutical market?”. Of course not! The unique serial number is primarily needed by the manufacturer. GMP rules suggest that it is the uniqueness of the batch number that allows you to accurately trace its entire history, starting from the raw materials, materials, equipment used, helps to quickly identify the causes of deviations (including primary records), as well as track and withdraw defective products from circulation.

Therefore, the state should not seek to establish a unified (same for all manufacturers) code for serial numbering. Such unification, with a high degree of probability, can lead to the loss of the uniqueness of the series number. It turns out that different drugs released in the same month, and also from different manufacturers, can have the same lot number. As a result, important primary data becomes very difficult to trace, and uncertainty and confusion are introduced into the supply chain for distributors and pharmacy chains.

Shelf life

The requirement to mark the expiration date on the consumer packaging of a medicinal product is stated in national laws, industry guidelines, as well as in good GMP/GDP practices. Unlike the serial number, which is more needed by the manufacturer, the presence of information on the expiration date on the packaging is necessary, first of all, for the consumer. And not so much because it is clearly stated in the legislation, but to prevent the consumption of a low-quality product.

By definition, “shelf life” is the period of time during which a product (semi-finished product, finished medicinal product) is expected to retain its properties, subject to the storage conditions stated in the relevant specification. As a rule, the expiration date is determined by the period calculated from the date of its manufacture. Naturally, after the expiration date, the use of the product is unacceptable.

Accordingly, the state must ensure the unification of approaches specifically to applying the expiration date on the consumer packaging of the medicinal product. In almost all industries around the world, the expiration date is indicated on consumer packaging as follows:

• "Good for (hours, days, months or years)";
• "Best before (date)";
• "Use by (date)";
• "Use by (date)."

In turn, the expiration date is usually indicated as follows:

• hour, day and month - for perishable goods;
• day and month - if the expiration date does not exceed three months;
• month and year - if the expiration date is more than 3 months.

In most cases, drugs have a shelf life of more than 12 months, so the generally accepted approach is to use the month/year format.

Everything seems to be simple, but there is a problem. Take, for example, the marking “Best before IV 2014”. Everything is according to the law - the month and year of the expiration date are indicated. But a stupid question arises: what day of the month should be considered the expiration date - April 01, 2014 or April 30, 2014?

Serious immersion in the world's regulatory documents leads to two options for the correct answer. One option is ours, the second is overseas. In our countries, it is generally accepted that “Best before IV 2014” means that the medicinal product cannot be used after March 31, 2014, i.e. the drug is valid until the first day of April 2014. This approach is adopted not only in the pharmaceutical industry, but also in other industries. For example, in confirmation of this, a quote from GOST R 51074 for food products: “... 3.5.10. With an expiration date exceeding three months, the expiration date continues until the first day of the indicated month ... ".

But there is another point of view. For example, in the European Union, the expiration date of medicines, like ours, must have the format MM / YYYY (month / year), but the expiration date is the last day of the specified month. This position of the European Medicines Agency (EMA) is explained in document CPMP/QWP/072/96/EMEA/CVMP/453/01 **,*** :

“The shelf life of an industrial series should be counted from the date of issuance of a permit for its implementation (date of issue). Under normal circumstances, the period before the date of issue of such authorization shall not exceed 30 days from the date of manufacture.

If the marketing authorization of the batches is issued after the prescribed 30 days from the date of manufacture, then the date of manufacture should be considered the start of the shelf life.

In this case, the date of manufacture is the date of the first production operation associated with mixing the active substance with other components. For medicinal products that are the active substance placed in a container, the date of manufacture is considered to be the start date of the filling operation.

To prevent misinterpretation of the text of this document, additional explanations and examples are provided on the official EMA website (see table).

An example of calculating the expiration date for a medicinal product with an expiration date of 2 years

At the same time, according to the EMA, this approach cannot be considered acceptable for drugs with a shelf life of up to 12 months. For such drugs, the expiration date should be calculated up to a specific day in the format DD/MM/YYYY and then "rounded" back and forth to the format MM/YYYY. For example, the expiration date of 01/14/2013 should be printed on the packaging as "12/2012", and the date 01/15/2013 should already be written as "01/2013".

But if we return to the text, then we can make one more important clarification. In the event that a non-conformity from the previous (s) series (s) is added to subsequent batches of the product, the shelf life of these (subsequent) batches will be calculated from the date of commencement of production of the series, of which the non-conformity is a part. For example, if on 03/25/2013, during the mixing operation to obtain a tablet mass, a certain amount of crushed substandard tablets from a previous batch (the production start date of which is set as 02/12/2013) was added to it, the expiration date of the new batch will be calculated from 02/12. 2013 (worst case).

Expiry date vs. Shelf life

It looks like the hardest part is over. However, the simple concept of “shelf life” becomes incomprehensible when “shelf life” is mentioned. When you start thinking about the differences in these terms, another stupid question arises: how is the expiration date different from the expiration date? The search for an answer to this question has already caused confusion in the regulations of Ukraine and Kazakhstan. In Ukraine, the terms "shelf life" and "shelf life" are used as synonyms. Kazakhstan has gone a little further. For example, in the Rules for establishing the shelf life and re-control of medicines, it is written: “...5. Stability tests and the determination of the shelf life and re-control are carried out on medicinal products. A warranty period of operation is established for medical devices and medical equipment ... ”At the same time, Section 2 of the same Rules establishes the following definitions of the shelf life and shelf life:

“... expiration date is the date after which the medicinal product, medical device and medical equipment cannot be used; shelf life - the period of time during which the medicinal product, under proper storage conditions, meets the quality and safety requirements of the medicinal product ... ".

From a regulatory point of view, the correct interpretation of these terms is given in the previously mentioned GOST R 51074: "shelf life is the period during which the product, under the established storage conditions, retains the properties specified in the regulatory documentation." Expiration of the shelf life does not mean that the product is not suitable for its intended use. It turns out that after the expiration of the shelf life, the product can change its properties (honey - candied, bread - stale), but the product can be eaten before the expiration date, if any. While “shelf life is the period after which the product is considered unsuitable for its intended use.” Relatively speaking, such a product can harm the life and health of the consumer, so selling it is prohibited by law. This is especially true for meat, dairy products and confectionery. When the manufacturer indicates the shelf life of the product, he warns that during this period the product fully retains its taste, texture, aroma and useful qualities. However, if the shelf life has expired, this does not mean that the food product is unfit for consumption. A good example is honey. At the end of the storage period, honey may darken or sugary, but it will still be safe and even useful. But if the expiration date has expired, then it is better to refrain from such a delicacy. Another example is grape wine. Wine bottles are often labeled with "guaranteed shelf life: 3 years", and next to it is the inscription: "Expiration date is unlimited". Thus, the manufacturer warns the consumer that after 3 years the taste of the wine in this bottle may change, but the wine will never become poison, it will simply “sleep” and wait for its finest hour.

Human medicines are not grape wine or honey. The use of medicines is associated with a high degree of risk, and here confusing the consumer in a variety of terms is unacceptable. This is a cyborg from a computer game with three lives. A drug has only one life. Accordingly, the concept of “shelf life” is inapplicable for a medicinal product, just as the concepts of “warranty period” and “service life” that are acceptable for medical devices are not applicable. For medicines, we should only talk about expiration date and expiry date.

Expiry date vs. Implementation period

Everyone knows that licensing terms, GDP and GPP good practices prohibit the sale of expired drugs. And I have one more “simple” question: can the expiration date be equal to the expiration date? In other words, when should the pharmacy withdraw a drug from the market - at the time of the expiration date or a little earlier?

According to the same GOST R 51074, the sales period is the period during which the product can be offered to the consumer for its intended use. Of course, you can brush aside and say that this applies to food products. However, think about it, does this also apply to drugs? After all, the implementation period is set taking into account some reasonable period of storage and use of the product at home. That is, if the consumer packaging of a medicinal product is designed for a two-month course of treatment, can the drug be considered expired in a pharmacy (or even more so at a distributor) already 2 months before the expiration date?

Naturally, it makes no sense to apply the expiration date on consumer packaging, this will only further confuse the entire supply chain and the end consumer. But it is still worth thinking about the deadline for the sale of drugs from pharmacies. For example, you can introduce a restriction of the following nature: "... A medicinal product can be sold to the end user with a residual period of at least 2-10%, depending on the expiration date and the number of doses in the consumer package ...". This will always leave a reasonable margin of time (from several days to 2-3 months) before the expiration date so that the consumer does not have to eat the entire package as soon as he brings it home.

And in conclusion, in fairness, I would like to return to the interpretation of the expiration date accepted in our country. Perhaps it was the concern for the health of the consumer that became decisive in the interpretation of the expiration date as "until the first day of the specified month." After all, every time, speaking of the "first number", we are guaranteed to have one month left. However, on the other hand, if, based on the results of studying stability, the shelf life is set with a margin, as is customary in the pharmaceutical industry, then such a norm only reduces the competitiveness of domestic drugs.

So it turns out that life is made up of such trifles that often do not add up.

Conclusion

The GMP rules contain only definitions of the terms “batch number” (eng. batch number, lot number) and “shelf life” (eng. expiration date, expire date). There are no requirements for the structure of the batch number code in the GMP rules, there are no rules for calculating the shelf life. The rules for applying the expiration date on the label in world practice are regulated mainly by industry standards, but, as a rule, unified with other industries. At the same time, it is important to understand the difference in terms of “shelf life” and “shelf life”: the shelf life is established in the study of stability, and the shelf life is applied to consumer packaging. But the coding of the batch number is the realization of freedom of choice for each drug manufacturer, with the only condition that the batch numbering should not violate the principles of traceability and lead to confusion.

Sources:

MU 9467-015-05749470-98 “Graphic design of medicines. General requirements".

Draft Annex to the Decision of the Eurasian Economic Commission on the requirements for labeling medicines in the Customs Union, 2011.

GOST R 51074-2003 Food products. Information for the consumer. General requirements"

CPMP/QWP/072/96 (EMEA/CVMP/453/01) Note for Guidance on Start of Shelf-Life of the Finished Dosage Form (Annex to Note for Guidance on Manufacture of the Finished Dosage Form), 2001.

Guidelines of the Ministry of Health of Ukraine 42-3.1:2004 “Quality Guidelines. Medicines. Pharmaceutical development.

Guidelines of the Ministry of Health of Ukraine 42-3.3:2004 “Quality Guidelines. Medicines. Stability Study"

Guidelines of the Ministry of Health of Ukraine 42-3.4:2004 “Quality Guidelines. Medicines. Manufacture of finished medicines.

Decree of the Government of the Republic of Kazakhstan dated December 5, 2011 No. 1459 “On approval of the Rules for the production and quality control, as well as conducting stability tests and establishing the shelf life and re-control of medicines, medical devices and medical equipment”.

Harmonized guidelines ICH Q1A "Stability studies of new drugs"

* Unique [lat. unicus] - one of a kind, different from others, exceptional, inimitable.

** Does not apply to biological products such as vaccines, serums, toxins and allergens; drugs derived from donated blood and plasma, as well as biotechnological products.

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Surely, many have seen the same product on store shelves with different expiration dates. One product was produced a couple of days ago, and the other in two days will no longer be suitable for consumption. Another example: you open a chocolate bar, and there is a strange white coating on it, although everything is in order with the expiration date. In this case, perhaps the problems lie in the shelf life. TAM.BY tried to sort out this confusion.

Shelf life

Expiration date - the period after which the product (the result of work) is considered unsuitable for its intended use.

The expiration date can be specified both as a specific date (Expiry date: 05/01/2019) or as a time period (Expiry within 12 months).

By law, the sale of expired products is prohibited. And we already wrote about what to do if you found an expired product on the counter.

Shelf life

Shelf life - the period during which the product (the result of work), subject to the established storage conditions, retains the properties and characteristics specified in the regulatory documents that establish requirements for the quality of the product (work, service), and (or) in the contract.
(Chapter 1, Article 1 of the Law “On Protection of Consumer Rights”)

Often buyers think that expiration date and shelf life are one and the same. But it's not. Often both terms are indicated on the packaging. But after the end of the shelf life, the product may change some of its qualities, but it will remain usable.

The difference between shelf life and shelf life is easy to explain using honey as an example. On average, its shelf life does not exceed 12 months, which is indicated on the package. But this does not mean that after a year this product cannot be eaten. It just changes the look. For example, sugary. But it will not lose its useful properties.

But be careful about dairy and meat products, medicines. If the shelf life has expired, then it is better to refrain from using them.

Life time

Service life - a calendar period set in days, months, years, or operating time set in hours, cycles of operation, kilometers of run or other similar indicators provided for by law or an agreement based on the functional purpose of the product (result of work), during which the manufacturer ( the contractor) undertakes to provide the consumer with the opportunity to use the product (result of work) for its intended purpose and be responsible for the shortcomings that have arisen through his fault.

In simple words: by setting the service life of the product, the manufacturer guarantees that during this time the product will be in good condition and will not harm the life, health, or property of the buyer.

There are goods that can be sold without a specified service life. In this case, the manufacturer is obliged to ensure the safety of the goods within 10 years from the date of its sale.

Guarantee period

Warranty period - a calendar period set in days, months, years, or operating time set in hours, cycles of operation, kilometers of run or other similar indicators provided for by law or an agreement, during which the product (result of work, service) must comply with the requirements for its quality, determined in the manner prescribed by law.
(Chapter 1, Article 1 of the Law “On Protection of Consumer Rights”)

If we talk about the warranty period and service life, then here, too, consumers are often confused and I think that there is no difference between them. In fact, these concepts are different.

The service life is set by the manufacturer based on the functional purpose of the product. But the warranty period can be set by both the manufacturer and the seller. In this case, the purpose of the product does not play a role.

Another difference is that the service life begins from the moment the product is manufactured, and the warranty period starts from the moment it is handed over to the customer.

The established service life obliges the manufacturer to bear obligations to the buyer. This applies, for example, to repair and maintenance, production and delivery of spare parts to sales outlets and repair shops. The manufacturer is also liable for defects in the product caused by the fault of the manufacturer.

We considered the nuances of returning goods under warranty in

Manipulation marks on the packaging provide information on the contents. Such information will help prevent damage during transportation, warehousing and storage. The markings on the packaging are varied. Symbols and codes applied to the surface of the container have a meaning approved in GOST. Designations on containers in the form of icons are divided into warning, information. Their meaning is the same throughout the world.

Man. the signs on the boxes suggest that the loaders are manipulated according to the regulations. Inscriptions, labels carry useful information about the product, its quality, and the method of its disposal.

Umbrella sign and open box logo

On the container you can often find a sign in the form of an open umbrella. Its decoding is simple - you can store the container in a dry place. The drawing is made in accordance with GOST 14192-96.

The packaging may contain signs in the form of an open box, its variations. The sun is shining from above. In the presence of such signs, the cargo must not be placed in direct sunlight. Similarly, there may be signs that warn against exposure to radiation on the box.

What do the glass and fork on the package mean?

If the packages have such a sign, this means the use of non-toxic materials. Marking indicates complete safety for humans. A similar sign is placed on packages and other goods. For example, on dishes. A glass and a fork - indicate that utensils are used for any dishes.

A similar sign, but crossed out crosswise. The label has the complete opposite meaning. Talks about the likelihood of harm to the human body when in contact with food. Usually the sign is indicated on non-food plastic.

Mobius loop sign

The Mobius strip or the Mobius loop is used on packages in accordance with the Rules of the Customs Union No. 769 dated 08/16/11. This sign is used within the framework of the special regulation "On the safety of packaging".

Similar designations are used for packaging products manufactured in other countries. There are international standards. Designated by ISO 7000, 14020, 14022. The tag on packaged goods indicates the possibility of processing. There are several types of sign. The color of the pictogram depends on the material.

Similarly, for metal, glass and materials of organic origin, there are their own labeling formats for such a loop. Signs must be affixed to the packaging. There are other ecological designations.

Rostest sign

The packaging of many goods suggests the PCT (Rostest) mark. There are 3 types of this kind of icon. The sign of mandatory certification in the GOST R system is most common in our country. For example, in the field of precision technology there is no product that should not be tested and not subject to certification. After that, a sign must be applied to the packaging. Its geometry is regulated by GOST R 50460-92.

A number of goods and products are not subject to verification. But the manufacturer or supplier has the right to declare the desire to undergo voluntary certification. In this case, the PCT mark is affixed to the product with the corresponding signature - “voluntary certification”.

Goods that are checked for compliance in a special GOST R system should also receive special marking. For this, the manufacturing enterprise registers a declaration confirming compliance. There is a sign on the box.

What does the LOT sign mean?

On boxes delivered from abroad, there is usually a LOT sign. Its value is easy to determine. From English, this name is translated as "party". It means a certain amount of products that went on sale at a time. Moreover, the number indicated next to the inscription LOT may contain various data. This may be the date of manufacture, production series, control number. Numerical markings depend on the purpose.

Sign on glass packaging

Transportation of easily damaged products implies the observance of certain rules. For example, the transportation of glass in any form requires compliance with certain conditions. It is for this purpose that a special designation in the form of a glass is applied to the packaging. It indicates the presence of fragile goods. It can be precision engineering, microelectronics, art objects and more.

Labeling of plastic containers

Everyone uses plastic containers, other items made of such material. Recycling is required after use. Plastic bottles and other items require special signs. These are triangles, rings. They indicate the method of processing, the class of plastic (food, industrial). All this must be taken into account. Designations can be affixed anywhere on the surface.

7 main types of plastic:

The presence of an icon in the form of closing arrows implies the possibility of recycling. Designations in the form of icons of this type indicate the class of the material - it is a secondary raw material.

PAP sign

On the labels of goods, various packages, you can often find the PAP icon. It indicates the class of processing and is supplemented with a couple of numbers. They indicate the class and type (cardboard, glass, plastic or other), allow you to get other data. European Union Directive 94/62/EC governs this standard. A couple of numbers are put with PAP:

1-19 - set for various types of plastics;

20-39 - such marking is affixed on paper and cardboard;

40-49 - encoding is intended for metals of various types;

50-59 is wood;

60-69 - various types of fabric;

70-79 - intended range for glass.

Recycling signs

In the EEC countries there is a similar document. The designations for recycling are completely identical. There are no differences. For example, PAP 21 is a regular cardboard.

Some rooms remain free. Over time, new materials are added to the classification.

What does the abbreviation EXP stand for?

The label on foreign products often contains the EXP badge. It deciphers quite simply. EXP is an abbreviation for the English expiration date. It translates very simply - "expiration date". There are always numbers next to such a sign. They indicate the date until which the performance characteristics of the product must be maintained.

A similar designation is present on goods for human consumption. Labels marked in this way can be placed on the bottom or on the lid. There is also an alternative designation of the expiration date - best before. It translates as "use to the end." Again, the date is written next to it. The application of such designations must be carried out in a manner determined by special standards.

PP and EAC mark

The PP mark is mandatory on polypropylene products. Recycling is possible, icons like the Mobius ring are used. Dishes made from this material are considered completely safe. It easily withstands temperatures up to 100 0 C. But doctors do not recommend drinking from it. This can lead to kidney disease.

EAC is the Eurasian analogue of the domestic PCT designation. EAC stickers indicate that the products have passed all the checks specified by the technical regulations of the EurAsEC Customs Union. This allows you to distribute the goods on the territory of all participating countries. Designation requirements have been established. The size must be at least 5 mm. The designation has been used since 2013.

What does PROD and MFD mean on the package?

Labeling requirements for many products oblige the manufacturer to indicate information about the date of manufacture. It is for this purpose that the PROD sign serves. The date must be indicated next to this inscription. For example, if the designation looks like this - "PROD 03 2017" - then the product was manufactured in March 2017. That allows you to determine its suitability. Packaging materials must contain data on the period during which the product retains its qualities.

MFD is a special sign that allows you to identify the manufacturer. Fully sounds like Manufactured. Often, instead of MFD, the sign MFG is used. The meaning of those is completely identical.

Badges on food containers

Container labels for food products are diverse. Knowledge of these is required for all without exception. Food storage is allowed only in special packaging. The transport specifications must be observed. Otherwise, food may spoil. For boxes, packaging, special designations are used. They depend on the type of product, as well as on what packaging products are used.

The supplier is required to indicate the type of goods:

for food products (fork and glass);

for non-food (crossed out glass and fork).

Product Certification Marks

In addition to the PCT and EAC, there are other certification marks. It is necessary to use only goods that have passed a special test. It is indicated by the icons:

Symbols allow you to determine whether products belong to a certain category.

sealed packaging

Manipulation actions with some cargoes should be as careful as possible. For example, with hermetically sealed. There is a special sign to designate such a container.

The sign indicates the inadmissibility of opening the package. The designation format GOST 14192-96 is regulated. You can get to know him at http://docs.cntd.ru/document/1200006710.

Quality Marks

There are many distinctive designations for high quality goods. Marking is not mandatory. The most common in Russia:

warning signs

Proper transportation by a transport company is a guarantee of the safety of the cargo, its safety. It is important to pay attention to the warning signs:

STR sign

It is a designation of a product that has passed the conformity check in a special GOST R certification subsystem. Unlike the PCT, it does not include an authority code. Also, the requirements of technical regulations are mandatory. Voluntary passage of the text of the STR is not expected.

Shelf life after opening

Many products have an expiration date after opening. Such a measure is required due to the increased likelihood of bacteria getting inside the package.

An expiration date is written next to the icon.

Cosmetics packaging badges

The most common designations on cosmetics:

Conclusion

Designations on containers, packaging must be interpreted correctly. This will avoid damage to the cargo during its transportation, improper operation. There are signs that are mandatory and voluntary. Do not use products that have not passed certification - if required by the legislation of the Russian Federation. It can be dangerous to health and life.

Be especially careful with food packaging. Not all plastic is safe. It can change its properties over time, as well as under the influence of temperature. Today, many designations are used in the Russian Federation and other countries. In Russia, GOST standards are used. In other countries, marking is carried out according to ISO. Most of the characters match.

On all cosmetic products without exception, it is mandatory to indicate the date of production: most often it will be indicated on the packaging in the usual form. month year" or " date/month/year". But sometimes the production date is not indicated in clear form - instead, a code is applied that is convenient for the manufacturer, but does not provide any information to the average person.

In this case, carefully examine the package (usually the code is printed on the bottom of the container: bottle, tube, etc.; in addition, it can be printed on the bottom of the package) and determine the exact production date using the Cosmetic Calculator.

Now for the expiration date. According to the law, it is mandatory to indicate the expiration date of a cosmetic product only if it is less than 30 months. It is designated as an inscription like: Exp 09/2010. And this means that this product retains all its properties and qualities until the expiration of the specified date.

If the expiration date is not specified, then it is a priori 30 months or more. But this does not mean that this cosmetic product can be used throughout this period. Look for the symbol on the packaging in the form of a jar with an open lid. It usually indicates the term of use from the moment of opening - in this case, 12M means that from the moment the package is opened and the first use, this cosmetic product retains all its properties and qualities for 12 months.

Indeed, as soon as the jar / tube / bottle were first opened and even more so used, cosmetics begin to deteriorate.

Naturally, in order to find out if cosmetics with such a label are expired, you need to know exactly when it was opened. Let us note again - it was not bought, but opened (unfortunately, this can often happen before the purchase; but it happens that you open cosmetics not immediately after the purchase, but much later). Ideally, make it a rule to mark the date of the first use of cosmetics directly on the package. To find out how long you should use this tool, all that remains is to find a special symbol in the form of a jar with an open lid and an indication of a number with the letter M - that is how many months you can use this tool from the moment it is unpacked.

That is, there are two different ways to indicate the expiration date of a cosmetic product: cosmetics that “live” for more than 30 months are marked with an icon indicating the term of use from the moment of opening; and the rest marks the expiration date in months from the date of production.

Of course, the current labeling system causes a lot of confusion. For example, is it not always possible for a product with an expiration date indicated (that is, it is less than 30 months) to be kept open for 24 months without harm? Conversely, when there is only a mark "to use 6 months from the date of opening", it is likely that the expiration date (30 months or more) has already been exhausted.

Ideally, both dates should be indicated on the cosmetic product. Therefore, European legislation introduces a new concept - "minimum shelf life" - "the date until which a cosmetic product fulfills all its properties and does not pose any danger to the consumer." The new concept also includes a new logo in the form of an hourglass with the date (“ month year" or " day month Year»).

Cosmetics with a similar label have already begun to appear on the European market, but it will become mandatory for everyone later.

Free legal advice:

Average "lifespan" of cosmetics

The shelf life of a cosmetic product most often depends on the consistency of the product and its composition. But there is also an average "lifespan" of cosmetics - on average, the shelf life of a cosmetic product varies from 3 months to 3 years:

• perfume, eau de toilette, eau de parfum– up to 3 years;
• powder(including blush, powder eye shadow) - from 1 to 3 years;
• tone cream in a jar or cream powder– from 1 to 3 years;
• liquid foundations(in tubes or jars with a dispenser) - 1 year;
• nail polish- 1 year;
• sunscreen cosmetics– 1 year (but not more than one season);
• lipstick, lip gloss- 1 year;
• contour pencils(for eyes, for lips) - about 1 year;
• facial skin care products(moisturizing cosmetics, against wrinkles, for the eye contour) in a sealed package with a dispenser - about a year, in a jar - from 6 to 10 months
• solid eyeliners and eyebrow pencils- from 6 to 8 months;
• tanning- 6 months;
• Mascara– 3-6 months;
• liquid eyeliner– from 3 to 4 months.

Separately, we note that natural and biocosmetics, which do not contain preservatives, are stored for a maximum of 6 months from the moment of opening. The fact is that the absence of preservatives leads to a faster reproduction of fungi and bacteria.

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What is the date on the package

We are used to how domestically produced goods are labeled, but imported goods sometimes raise questions. Today we will talk only about the dates that are present in the labeling of imported goods.

Free legal advice:

For food and drink, two types of marking dates are considered the most legal: "Use by" - use by the specified date and "Best before" - best before the specified date.

"Use by" means that the retailer must ensure that the product is not offered to customers after this date. That is, after the "Use by" date, the product should not be sold.

"Best before" means that the product is of the best quality before the specified date. After this date, the quality will gradually deteriorate. Unlike "Use by", the law allows products to be sold after the "Best before" date. This label is used on products that are less perishable.

Sometimes you can find the following markings: “display until” (show, offer until) and “sell by” (sell by). Most often, "display until" and "sell by" indicate dates two or three days before "Use by" or "Best before. These alternative markings have no legal significance. They are an invention of sellers, designed for convenience and speeding up sales.

The following types of dates can be found on non-food products: "Date of manufacture / production" (date of manufacture or production), "Expiry date" (expiration date), "Recommended life once the product has been opened or put into use" (recommended service life after the opening of the goods or the start of operation). Most often, these dates are used on non-food products such as toothpaste, cosmetics, batteries, etc. It should be noted that abbreviations are possible when marking. For example, write EXP SEP 93 instead of EXPIRY DATE: SEP 93, MFD 7/91 instead of MANUFACTURED 7/91, or PROD 08/95 instead of PRODUCTED 08/95.

Free legal advice:

Now, having met on the package an inscription of the letters PROD and numbers, you will know that it indicates the date of production (manufacturing) of the product, and the following inscription EXP 09/00 means the expiration date.

EXP date on packaging - what does it mean?

Often a question may arise when buying a medicine or cosmetics, for example, a body cream: what does EXP mean on the package? What are those weird letters? Let's decipher them.

EXP (or “exp date”) is an abbreviation for the English “expiration date”, which means “expiration date” in Russian. Those. the date indicated next to these letters indicates the day, month and year after which the purchased product is not recommended to be used.

Other designations

How else is the expiration date written in English? It can be the phrase "best before (end)", which means: "use before (end)". If it is not a food product that is consumed, then "use before" is meant.

Free legal advice:

Sometimes the expiration date in English is marked on the packaging with such designations: “Use by”, “Best by”.

Exp: 8/2018 - expiration date until August 2018.

Best before end 07.2017 - use before the end of July 2017.

We hope that the information was useful for you, and thanks to such a small and necessary knowledge of English words and abbreviations, you will not use the purchased products after the expiration date indicated on the package.

Free legal advice:

Writing your task to order

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Expiry date as indicated

A series (in English Batch) is a certain amount of a product produced without changing the conditions from a certain amount of raw materials without stopping production (as if from one “batch”).

Free legal advice:

Lot (in English Lot) is the number of products (possibly different series) offered for sale at one time (or sent to the buyer).

Series numbers may include date of manufacture. Here are examples of series designation on packages:

Series No. (the first four digits indicate the year and month of production);

Free legal advice:

The word "series" is not always present on domestic packaging. Sometimes a five-, six-, or seven-digit number is simply stamped.

Charge - Nr .: (takes into account the month and year of production)

No. or B 0615.

Free legal advice:

Sometimes, instead of a series, a control number is indicated on the packaging of imported products, for example: "Control N" or "O". N. 1109/56".

Lot or batch number is indicated on import packages. Examples: LOT#0471; LOTZ31001FS; LOT674HD; LOT; lot no. 67.

Various options can be used to indicate expiration dates. The expiration date is calculated from the date of production. Therefore, the markings most often contain information about the production date (it can be included in the batch number) and (or) the expiration date is indicated. Alternatively, the date of manufacture and the number of days, months, or years that the product is usable are indicated. For example: “The release date of V is 1989. Shelf life is 5 years.

Expiration dates are often labeled "Best by", for example:

Sell ​​by:

Free legal advice:

Validity up to:

Expiration date 07/98 or (simplified): milked.

The expiration date of imported medicines and dietary supplements is indicated using the word Expiry (English "expire"), and in German transcription - Verwendbar bis. Examples of expiration dates: EXP 7/94; EXP SEP 93; EXPIRY DATE:; Verwendbarbis:. Sometimes the expiration date is indicated as follows: BEST BY 09/00 (it is better to use before 9/99); USE BY 08/02 (use before 08/02).

On labels for mineral waters, the dates of manufacture (bottling) are indicated by notches on a special linear scale “months-years” located on one of the side strips of the label, and the words indicate how long the product is good for (usually 12 months).

Very often, incompetent buyers mistake the inscription for the designation of the expiration date of imported dietary supplements: U 1997 AN rights reserved. Such a typographically executed inscription is present on many products that have duly protected brand (trade) names. Literally, this means that in 1997 all rights of the company are reserved for the use of brand names on packaging with its products. This inscription has nothing to do with the expiration dates of the products. The expiration date should be looked for with a printed stamp separately on the same package.

Free legal advice:

The date of manufacture may be included in the batch number, or may be listed separately. In English transcription, an abbreviated version of the word "Manufactured" is often used - "Mfd" - produced (sometimes "Mfg"). In the German transcription, the date of manufacture is Herstelldatum. Examples of production date designations:

What does "Exp" mean on the packaging of imported cosmetics?

For example, Exp: 01/20/2012. Is this the product's manufacture date or expiration date?

1. The expiration date is always indicated on the packaging. In Russian: "Best before." or in English: "EXP. . "

Shelf Life, Expiration Date ("Shelf life") - the time during which, subject to the storage conditions and rules of use, the quality of the product is guaranteed. If the storage conditions and the rules of use are not observed, the product may deteriorate earlier than the specified period.

The words Exp or Expirydate can be found not only on the packaging of imported cosmetics, but also on the packaging of medicines, medicinal ointments, food packaging, etc. "Expiring date" is also the expiration date.

Free legal advice:

Cosmetics can be used until the specified date, time.

What does the inscription "Exp" mean on the packaging of the goods, as translated into Russian: "Exp" is the Expiration Date or in another way - the expiration date of this product, it is up to this date that it can be used or eaten.

For example, I photographed the inscription on the makeup remover.

Usually, they try not to write the production date (a marketing ploy), but manufacturers are required to write the expiration date.

I noticed that I increasingly come across a product with the inscription "Exp". I would like, of course, to use the goods of a domestic manufacturer, but it turns out that more than half of the goods on the shelves are imported. It's a pity.

Free legal advice:

I also often paid attention to this designation. I rummaged through the Internet and found information that on packages with imported cosmetics, the symbols "Exp" indicate the expiration date, namely, until what time this or that product is good. Well, this, of course, subject to the rules of storage and use.

This means expiration date. As well as on Russian products there is an inscription "Best before. ", foreign products have EXP. It translates like this: "Shelf Life, Expiration Date" and after this entry there are numbers. For example, the same as you indicated in your question Exp: 01/20/2012 .

This is an abbreviation for expiration date, translated as "expiration date"

This is the same as "Best before" or "Use by"

So Exp: 01/20/2012. this expiration date ends on January 20, 2012, you must use this product before the indicated date

Free legal advice:

The inscription on the packaging of cosmetics or other Exp products is similar to our "shelf life" until such and such a date. In this example, the expiration date is over in January 2012 - you need to urgently throw the item away. And that is fraught with allergies or worse.

Such a record on packages of foreign origin is translated very simply, this is an indication of the date until which this product can be used. And if we talk about the entry itself, then this is just an abbreviation for Expiration Date.

On foreign packages / import packages (in your case, imported cosmetics), as well as on our Russian goods, etc., there is an inscription about the expiration date of this product.

Since this is an imported product (cosmetics), the inscription on the expiration date is written in English. In English, the expiration date or expiration date is Expiration Date, indicated on the packages as Exp.

Exp. 01/20 is the expiry date.

The inscription exp on imported cosmetics means "use until." That is, the expiration date of foreign cosmetics.

Free legal advice:

I often buy expensive cosmetics, and to make sure it's authentic, I check it by barcode on the website http://kiev-security.org.ua/kod/index.pl

We also have it, only it is written not EXP, but the expiration date.

Expiration Date is the amount of time from the production of a product to its spoilage.

After the expiration date, you should not eat food.

Other markings;

During the expiration date, drugs must fully retain their therapeutic activity, safety and meet all the requirements of the NTD, in accordance with which they were released and stored under the conditions provided for in this documentation.

Free legal advice:

Production markings

Production markings include: series, lot, production date.

A series (in English Batch) is a certain amount of a product produced without changing the conditions from a certain amount of raw materials without stopping production (as if from one "batch").

Series - a certain number of drugs obtained as a result of one technological process

A lot (in English, Lot) is the number of products (possibly different series) offered for sale at one time (or sent to the buyer).

Free legal advice:

Series numbers may include date of manufacture.

Here are examples of series designation on packages:

Series No. (the last four digits indicate the month and year of production);

Series № (the series does not take into account the date of production)

Series No. (the first four digits indicate the year and month of production);

Free legal advice:

The word "series" is not always present on domestic packaging.

Sometimes a five-, six-, or seven-digit number is simply stamped.

Foreign version of the series designation:

B. No (takes into account the month and year of production);

Charge - Nr.: (takes into account the month and year of production) .

Free legal advice:

No. or B 0615.

Sometimes, instead of a series, a control number is indicated on the packaging of imported products, for example: "Control N" or "O.N. 1109/56".

Lot or batch number is indicated on import packages.

Examples: LOT#0471; LOT Z31001FS: LOT 674HD; LOT; LOT No.67.

Various options can be used to indicate expiration dates.

Shelf life - this is the period of time during which the drug must fully meet all the requirements of the quality standard.

The expiration date is calculated from the date of production.

Therefore, the markings most often contain information about the production date (it can be included in the batch number) and (or) the expiration date is indicated.

Alternatively, the date of manufacture and the number of days, months, or years that the product is usable are indicated.

For example: "Issue date V year. Shelf life 5 years."

Expiration dates are often labeled "best before", for example:

Sell ​​by:

Validity up to:

Expiration date 07/04 or (simplified): milked.

The expiration date of imported medicines and dietary supplements is indicated using the word Expiry (eng. "Expire"), and in German transcription - Verwendbar bis.

Sometimes the expiration date is indicated as follows: BEST BY 09/07 (best used before 9/07); USE BY 08/04 (use before 08/04).

The date of manufacture may be included in the batch number, or may be listed separately. In English transcription, an abbreviated version of the word "Manufactured" is often used - "Mfd" - produced (sometimes "Mfg").

In German transcription, the date of manufacture is Herstelldatum.

Examples of production date designations:

Date of production: 08/04

The expiration date is calculated in months and / or years and is determined by subtracting:

Expiration date = shelf life - date of issue.

The expiration date can be determined from the label.:

After the words "best before. » Roman numerals indicate the month, and Arabic numerals indicate the last two digits of the year.

Shelf life - calendar date on the individual packaging of the medicinal product, until which its properties, subject to proper storage, must meet the requirements of the quality standard. After this date, the drug is not to be consumed.

All of the above production indicators are stamped on the packaging. Typographically, only the names of the indicators themselves are indicated.

The product number according to the catalog of the manufacturer (or the company that received distribution rights) is most often affixed to the packages of imported dietary supplements and is indicated, for example: PRODUCT NO. 13667. This inscription is affixed to facilitate the work with the products of distributors when the company's product range is represented by a large number of varieties.

If the drug is produced by a company under a license, then the package contains information about the license holder (company name, trademark) and the license number may be indicated.

Tavegil® tablets are produced by the pharmaceutical plant EGIS A.O., Budapest, Hungary under license from Sandoz A.O. (Basel). This information is printed on the label bearing the trademarks of both firms;

The license number is indicated on the packaging of the licensed product: "Prod. Persons No: K T K / 25A / 272/94" or "Mfg. Lie. No. 6/766" or "Lie. No. 1528"; The manufacturer of the drug gives information on the packaging that he is a licensed user of the product - "Licensed Used".

In the case of co-production, an inscription such as: "Produced in cooperation with the company" is applied to the packaging.

On consumer packages of medicines and dietary supplements, the address of the manufacturer (distributor) may be present. The address may include the names of regions, cities, states, mailboxes, telephone, fax, e-mail address.

On transport packaging imported medicines is indicated by the number of the contract and the import permit.

Sometimes the label is marked with the stamp of the OTC (Technical Control Department), which gives certain guarantees of product quality by the manufacturer. The OTC stamp is often present on the packaging of chemical reagents.

An integral part of the labeling of medical devices is the Stamp - a sign certifying the quality of the product (QC, rejector number, personal brand, metal test).

The brand informs that the product has been subjected to control, checked by the QCD employees, it certifies certain properties of the product, the materials from which it is made, confirms that the product has been tested in accordance with the established rules.

On the packaging with pharmaceutical products, the number of the standard or other document, in accordance with which this product is manufactured, may be affixed.

Patient care items, dressings have an indication of the grade on the packaging.

Labels may also contain typographic signs that are not related to the product (signs of the printing house that ordered the printing of labels; technological designations understandable to specialists producing packaging or markings).

Shelf life and use EXP on the package

There are strict requirements for printing information on products offered in Russia. The date of manufacture and expiration date are the main ones after information on the composition of the product. But not everything is so simple for the average consumer. It is difficult to find these important figures and make out what is written. Often you have to solve charades from machine-made numbers and letters, and in different languages. How to correctly determine whether the product can be used?

Why is it important to know the expiration date?

A conscientious manufacturer indicates the “extreme” date with some margin in time. He is responsible for the quality of the product within the possible time of use and guarantees that the product will meet all the declared qualities.

What happens the day after the expiration date? In an hour, the product, of course, will not deteriorate. But after the expiration of the declared date, some of the properties will be lost. This is especially true for vitamin-containing products or pharmaceutical preparations.

Storage conditions are important. The general expiration date implies certain conditions: temperature and light conditions, humidity. Who will guarantee that all the time until the goods were in your hands, the manufacturer, carriers and sellers honestly observed the storage conditions?

The expiration date of the product is not the only thing you should rely on. There is another parameter - the storage time after opening the package. This is often found in cosmetic products.

After opening the tube, the new expiration date is indicated on the picture of the “jar with an open lid”, which, as a rule, indicates the number of months. For example, "6M". This means that the product can be used for a maximum of 6 months after opening.

Example. We bought sports nutrition with an innovative vitamin complex. Production date: 05/15/2014. At room temperature, the product in its original packaging can be stored for 2 years with the preservation of all the most useful and miraculous properties. Once opened, the product should be consumed within 3 months.

You purchased food on 09/01/2015. We opened the package on 09/05/2015 and did not have time to use everything in 3 months. On 12/05/2015, the product can be discarded, although the general expiration date would have ended on 05/14/2016. Here is such a simple arithmetic, which must be used in everyday life all the time.

Where can I find the expiration date?

There are no strict requirements for the placement of production dates and deadlines for use on packages.

• on the bottom or lid of the jar,
• on the label in the most unexpected places, on the seam of the sealing of the package,
• on the weld seam of the tube.

Sometimes it's unreadable. But information about production dates, expiration dates, storage modes, including after opening the package, needs to be found.

How to read the date of manufacture expiration date?

Not so simple. Sometimes only the date of release of products can be marked, and the consumer himself must add the shelf life. Sometimes dates are indicated not only for the production of the product, but also for the expiration date.

You can find almost clear inscriptions:

• Valid until: "01/05/2017" or "".
• Best before: 01/01/2018.
• Valid until: “01. 2010" or "".
• 08/14-07/17.

It is only necessary to decipher where is the year, month, and where is the date or shift number. On products with a long shelf life, the month and year are indicated, on perishable products, the date of the month is required, sometimes hours, if the shelf life is only a few days.

Everything is more complicated when foreign abbreviations are encountered. What does exp mean on the package, or - BBF? It is worth remembering the basic abbreviations.

1. BESTBY or USE BY ('better before...'). After the letters, the expiration date of the product is indicated.
2. Exp on the package means - expiration date. It is also EXPIRYDATE (‘expiring date’).

Not to be confused with MFG (Manufacturing), which means production date.

It remains to be hoped that bills will be adopted that will make life easier for the consumer. Maybe in the future you won’t have to solve puzzles, where is the date of manufacture on the package, and which of the set of numbers is the month or year. True, a single format will lead to producers' costs, which will affect the consumer's wallet.

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