The timing and stabilization of medicines. The shelf life of drugs
Hotel times medicines Adjusted by the ease of 1974. How long will we work according to the orders of the last century, the industry standard. Medicines. The procedure for establishing the validity of the OST 42-2-72.
In Oste there interesting moment: "1.3.2. The initial date of expiration date of the drug is taken by the date of the permission of the enterprise's deletion on its release. The shelf life on finished dosage forms is set independently of the expiration of the main substance. For the manufacture of ready-made dosage forms, only those drugs whose established expiration date has expired not more than on:
For medicines with an expiration date of 3 years - 20%;
For medicines with an expiration date above 3 years - 30%. "
Shelf life under the laws of the United States, starting in 1979, only means a date that the manufacturer guarantees the full efficiency and safety of the drug - this does not mean its present term and safe time storage. Studies show that overdue drugs may lose efficiency by 5-50%. Even 10 years after the expiration date, the majority of medicines retain their initial efficiency to a large extent.
One of the most large studiesconfirming the above, was held by the American military 15 years ago, according to the thematic article Laurie P. Cohen on March 29, 2000 in Wall Street Journal. At the disposal of the military was the stock of medicines worth $ 1 billion. Faced with the need to destroy and replace this stock every 2-3 years, the military department began a test program to find out whether it is possible to extend the life of an expensive inventory. Testing conducted by control food products And US drugs (FDA) covered more than a hundred prescription and non-receptible drugs. The results showed that 90% of them were safe and effective at least 15 years after the expiration of the initial shelf life.
The results of this program allowed the Flaherty specialist to conclude it that the shelf life was affected by the manufacturer, it does not directly attribute to the ability to use the drug after this period. Flaherty noticed that the manufacturer of the drug must prove its effectiveness only during the period that the pharmaceutical company will choose. The shelf life does not mean and does not even assume that by its expiration, the medicine will become ineffective or harmful. "Manufacturers indicate the shelf life rather with marketing than with scientific purposes, - approves former pharmacist FDA Flaherty. - They do not need goods with a ten-year storage. They need a turn. "
FDA warns that the program did not give enough evidence to the fact that any drug aid kit is effective and after the expiration date. However, Joel Davis, former leader The department for studying the maturity of the FDA shelf life, said that for some exceptions (the most noticeable of which nitroglycerin, insulin and some antibiotics in the form of a suspension) most of the drugs can also be stored for a long time as medicines tested for the military department. "Most of the medicines loses their properties very slowly," he said. Consider such a drug like aspirin. Bayer AG exhibits the shelf life of Aspirin 2 and 3 years and declares that after the expiration date, it must be destroyed. However, Chris Allen, the Vice-President of the Bayer, Vice-President, recognized these shelf life "very conservative": when four-year aspirin tested in Bayer, its effectiveness was 100%. Pharmacy workers can only keep the dates listed on the package and, without thinking to send "old" pills in the trash can. Or maybe in vain ...
Under the shelf life of drugs means the time during which this product fully meets all the requirements of the regulatory documentation. The initial date of expiration date is the release date. At the same time, the recommended storage conditions must be respected not only during storage, but also during transportation and sale.
According to Civil Code RF shelf life is recognized "Term, after which the goods are considered unsuitable for use." The legislation determines the list of such goods in which, in particular, LP.
In turn, the need for strict legal regulation The treatment of medicines is due to their high social importance as civil turnover facilities. It is extremely important that the drugs reach the end user reached not only effective, but also safe to health.
Usually, the products can be implemented with such a calculation so that the residual shelf life allowed the buyer to fully use it until the end of its shelf life. In connection with the sale of medicines, many questions arise, incl. The legal nature associated with the policies of suppliers and with what period should be considered sufficient for the use of drugs for its intended purpose.
Preparation with a short residual - This is a position that the residual shelf life is less than a year or less than 50% total Sucidity. Such a formulation can be found in many treaties between different subjects of the Russian pharmaceutical market.
For most buyers in a pharmacy, the value of the residual shelf life of the drug is not important. The shelf life factor plays a value for certain groups of drugs, such as:
- medicines for pregnant women and children;
- courced reception drugs;
- preparations that cannot be quickly used (large packing);
- medicines for people with a specific psychotype.
C point of view of the buyer, for most drugs, the value of the residual shelf life is not the most significant factor. For example, it is unlikely that the buyer is important for the residual shelf life for drugs from a cold, heartburn, allergies, headaches, anti-infinite drugs, etc. Such means are consumed almost immediately.
Many pharmacy organizations try not to take goods with a short residual shelf life, since the position will not be sold, the pharmacy staff will be to one degree or another to compensate for financial (material) losses.
Most suppliers propose to approve in the contract that the residual shelf life of the LP, which is profitable. Usually this limit varies from 80 to 50%. But can the shelf life within these limits, after passing a huge chain of intermediary firms, which can be at different parts of the country, to ensure the quality of the final consumer?
However, the turnover of commercial stocks in the pharmacy, as a rule, does not exceed 30-40 days. Then if you do not take into account listed above special groups Preparations, the presence in the assortment of pharmacies of goods with a residual shelf life of more than 3 months should not be a problem.
Pharmacies fear to take goods with a short residual shelf life for several reasons. Work with such goods requires a pharmacy:
- a developed planning system, accounting and determined personnel management system at the pharmacy level and (or) managerial competence of the head;
- special, separate procedure / technology work with goods with for a short time fitness; These products refer to a separate economic group of the range;
- the wage systems tied to an increase in the gross profits of the pharmacy.
At present main question It is which period should be considered sufficient for use for use, especially in the context of LP. Most of them, in contrast to food, for example, cannot be used for a short period of time, since it is designed for a specific treatment course, within which the patient must take this tool. Is it possible to consider "use for the appointment" when the patient until the end of the shelf life can only take half of the tablets?
At the same time, the court based on Art. 472 of the Civil Code of the Russian Federation, may fall on the side of the supplier, recognizing even a short term sufficient for the sale of goods, and a reference for this period is an insufficient basis for non-fulfillment by the buyer of its duties on the payment of goods. This makes pharmacy organizations with the most vulnerable link in the circuit of drug circulation.
In addition, there is such an opinion of Pharmacists in relation to such goods: they will not be sold, since buyers pay attention to the shelf life.
The network built correctly does not have a large warehouse stock. If the network will strive for turnover standards, then there should be no difficulties when working with such goods. However, experience shows that many pharmacy chains are faced with the problem of implementing drugs with a short shelf life, which go into the problem of goods with burning expirational terms. Difficulties arise when a commercial model pharmacy network Replaced by a model of distributor "Buy a lot with a discount".
Maybe popular drug Become in a pharmacy position with a short or even expiring date? Of course, if the pharmacy will form a hyperstok (see table).
Thus, for the pharmacy network it is advisable to determine the residual shelf life in terms of sales speed. To understand what amount of purchases to take, you must take into account several factors:
- probability without additional efforts to sell the entire purchased goods, before moving it to the category "Goods with expiring shelf life" (less than 3 months);
- the opportunity to get additional profits by purchasing drugs at a price below the average and selling them at a regular retail price (with a greater charge);
- mOSCOPTS for the implementation of this operation.
If we talk about this situation, the only salvation of pharmacy organizations is the freedom of contract and the ability to dictate conditions that are profitable for them. So, to reduce the risks, it is necessary to include conditions that will help balance the interests of the parties.
Firstly, install the supplier's responsibility in the contract when delivering goods beyond the fixed expiration date (for example, less than 50%), up to the failure of acceptance of goods.
Secondly, it is possible to include in the contract the condition about the return of the goods to the Supplier, not implemented before the expiration date . At the same time, there is a point of view, according to which in this case, given the conscientious fulfillment of obligations by the Seller, the refund is made in the form of a new supply contract, where the parties change roles. In turn, the obligation of the Buyer on the payment of goods on the initial contract may be on the basis of Art. The 410 Civil Code of the Russian Federation is fully or partially discontinued by a credentials for payment by the provider of the returned goods.
Talk about drugs with a limited expiration date!
According to clause 11 approved by the Order of the Ministry of Health and Social Development of the Russian Federation of August 23, 2010 No. 706n "Rules for the Storage of Medicines" in organizations and individual entrepreneurs it is necessary to keep records of drugs with a limited shelf life. on paper or in in electronic format Archiving. It is stated that the procedure for holding the accounting of these drugs is established by the head of the organization or an individual entrepreneur.
The form of the journal of accounting for the procurement of drugs and the procedure for its conduct of the current legislation is not established. In addition, the current legislation does not define a specific amount of the expiration date of the drug, which is considered limited.
Thus, the head pharmacy organization It is entitled to independently establish the value of the residual shelf life of the drug, starting with which such medicines should be recorded, the form of accounting magazine and the procedure for maintaining such a journal.
Weather accounting log template can be downloaded from the site site:
Journal of Accounting For Drug Snattless (9.0 KIB, 3 190 HITS)
For other goods pharmacy range The requirements for the conduct of accounting for goods with limited expirational timeliness are not established.
Thus, in relation to the non-drug assortment of the goods, the pharmacy head can, if desired, to approve the procedure for accounting for goods with a limited amount of shelf life, as well as the procedure for maintaining and storing accounting logs.
Organizations should be implemented established in the organization a system for taking medicines with a limited expiration date. If there are several episodes of one drug name on the storage, then the drug must be taken to use first of all, the shelf life of which expires earlier than others ().
According to paragraph 24 approved by the Decree of the Government of the Russian Federation No. 55 "Rules for the sale of individual types of goods" (as amended from 05.01.2015) the goods on which the shelf life is established, the Seller is obliged to transfer to the buyer with such a calculation so that it can be used to be appropriate until Shelf life.
Thus, the implementation in the pharmacy organization of the drug with expiring shelf life is possible, if according to the appointment of a doctor, the buyer will know that the drug will be able to use such a drug until the expiration date.
Thus, the implementation in the pharmacy organization of the drug with an expired shelf life is possible, if according to the appointment of a doctor, the buyer knows such a drug until the expiration date. The duty of the pharmacy organization on the prevention of the buyer about the residual shelf life of the drug sold by the current legislation is not established!
In accordance with paragraph 5.12 Methodical recommendations "Graphic design of medicines. General requirements"MR 64-03-004-2004 Approved by the Ministry of Industry of the Russian Federation No. 15 / 11-9, the shelf life should be indicated:" Give to the "month" year. " In this way, drug Treatment It should be considered suitable to use up to the last number of the month preceding the month indicated on the package.
The current legislation on the treatment of drugs has not established restrictions on the sale of drugs whose shelf life has not expired.
Drug storage is not an empty sound. It is believed that medicines can be used another year or two after the expiration date. However, over time chemical substancewhich is in the preparation is exposed to increased temperature, moisture, sunshine. In liquid dosage forms can multiply microbes, then the drug is able to cause other diseases.
Some medicines not only lose their activity, but also become toxic to humans. Specialists are recommended to check home Asthechka At least once a year, and without regret, to throw out all overdue medicines.
Let's consider the storage time of some known drugs.
Popartol: shelf life
Drops for the treatment of a cold, containing silver ions, should be stored in dark glass bottles. In the light, the medicine spars and loses all activity. Store the tool is permitted no more than 14 days. If the drops have changed their color, thumping them, especially since the price of the drug is not too high.
The shelf life of disposable syringes
Depending on the method of sterilizing the material, the shelf life of the syringe is from 3 to 5 years, provided that the integrity of the packaging is preserved. After the specified time through the smallest holes packaging material Viruses and bacteria can penetrate, the syringe loses its sterility. Use such a product is dangerous. You should also know that the syringes should be stored when room temperature in the closet or bedside table, away from sun raySo that the material does not make up prematurely.
Otipax: shelf life (including after opening)
Ear drops can be saved for 5 years if you have not opened the bottle. Storage temperature - no more than 30 ° C. After opening, the drop can be used for six months.
Activated coal: shelf life
The drug is stored for 2 years in a dry place. Activated carbon Easily absorbs moisture and volatile seats of substances. Therefore, if the packaging is wedroced or damaged, you should not take a medicine.
Linex: shelf life
Bacteria included in the capsules pass the complex lyophilization procedure (freezing and drying). The manufacturer ensures that by the end of the storage period of the medication in one capsule will be 12 million living bacteria. Term of preservation useful qualities The drug is 2 years at a room in the room no more than 25 ° C.
Mumina: shelf life
The medicine can be bought in tablets (Altai Mumina) and in powder (Kyrgyzstan). Storage period - no more than 5 years, in a cool place without access of sunlight.
Successful juice iodine
Alcohol tincture can be stored without changing its properties for 3 years. Over time, there is interaction between alcohol and iodine, the activity of the latter decreases.
The shelf life of hydrogen peroxide
Store substance follows in a tightly closed package from dark glass. The peroxide is easily decomposed. Formal term of use - 24 months, however, the tool may lose its activity earlier specified period. If, with a substance in the wound, hiss arises and bubbles appear - the substance did not lose its antiseptic properties. Otherwise, the effect of the application of hydrogen peroxide will not be.
Terms of storage of essential oils
Oils should be kept in a dark place at temperatures up to 15 degrees Celsius. Pharmacists advise to put the bottles in a vertical position. Standard storage period essential oil - 2 years. If the means are obtained by distillation with steam, they can be stored for a long time. The less oil remains at the bottom of the open bottle, the faster it flies.
Acyclovir, shelf life
If the drug is released in the form of tablets, it is allowed to be stored in a dry dark place 3 years (temperature - up to 25 ° C). Acyclovir ointment is stored at a temperature of not more than 15 degrees for 2 years.
Barsing fat: shelf life
The remedy is stored in the refrigerator at a temperature of not more than 5 degrees for 2 years. If you felt ruling or sour smell, Fat acquired yellow - Use it is not recommended.
Shelf life of Zelenki.
A means of powder and alcohol solution is performed. The powder can be stored for a long time, the liquid greenflaw - just 2 years.
Derinat: shelf life (and after opening)
You can use the tool for 5 years with the integrity of the packaging. After opening the bottle - only 2 weeks.
Analgin: shelf life
Tablets should be kept in a dry, protected from sunlight place, not more than 5 years. Ampoules can be used for 3 years from the date of release.
Supratin
Produced in tablets and ampoules. The shelf life of the medicinal product is 60 months.
Duration of storage of distilled water
Purified water for medical purposes (for pharmacies, laboratories) should be kept no more than 3 days. If water is used for injections - up to 24 hours in aseptic conditions.
Malavit: shelf life
A remedy for bottles that can be used for 2 years is available. The drug is used in a divided form, water solution Malavita retains its properties 24 hours.
3.1. Manufacturer Enterprise industrial production The new drug should continue research on the study of the stability of the drug and confirm or clarify the shelf life for making recommendations to regulatory documentation.
3.2. Control of the stability of the drug during the storage process and the conditions for its storage must comply with the requirements of the regulatory documentation on which it was produced.
3.3. The primary and secondary packaging of the studied drugs must comply with the requirements of the regulatory documentation on which the drug was produced.
3.4. When packaging medicines into large primary packaging (flasks, bottles, iron barrels, tin drums, polymeric bags, bags of paper 3 and 4-layers, etc.) To study stability, it is allowed to use similar packaging less capacity sufficient to simulate.
3.5. Samples of at least 3 industrial series of medicines should be taken to study the stability of medicines.
From each sample of the drug for periodic tests, a sample is taken to carry out the required amount of analyzes.
3.6. In the event of a significant change in the production of the drug production (change in the types and quality of raw materials, drying modes, cleaning, crystallization, etc., for example, for antibiotics - a change in the strain of producer and nutrient medium), this drug is compared in accordance with paragraph 2.3. and p. 2.6. With the same drug figures produced by unchanged technology.
3.7. The drug produced by modified technology is subject to testing in accordance with paragraph 2.6. and paragraph 3.6 only in the case of its properties of paragraph 2.3. With the properties of the sample released on the old technology.
3.8. Before laying on storage, all drugs are fully verified for all indicators in the amount of requirements of the current regulatory documentation with a record in the stability research results table.
Notes
1. With subsequent checks, indicators that cannot change during storage are not determined (for example, the content of sulfate impurities, chlorides, etc.).
2. In all indicators of the current regulatory documentation, there is also an inspection in cases:
Detection of deterioration of the drug during its storage;
When preparing materials to extend the shelf life.
3.9. Drug samples that are on learning are subject to verification in the following dates:
Under the expiration date on the regulatory documentation up to one year - every 3 months;
Under the shelf life of 3 years - every 6 months;
Under the shelf life of more than 3 years - after 12 months.
4. Storage conditions for samples when studying stability
4.1. Drug samples selected for stability should be kept in a special room in packaging and conditions that meet the requirements of the current regulatory documentation.
Drug samples of the list A should be stored in special conditions defined by the competent authorities.
4.2. Indicators of temperature and humidity of premises and, if necessary, other parameters should be entered into a climate control log.
Approve
First Deputy Minister
medical industry
I.M.Tezhilkin
Approve
Deputy Minister
health of the USSR
A.F. Sernko
Sectoral standard
Medicines. The procedure for establishing expiration
OST 42-2-72
Entered for the first time
The deadline is set
Failure to comply with the standard is prosecuted.
1. GENERAL PROVISIONS
1.1. This standard regulates a single procedure for establishing the terms of the shelf life of medicines, mandatory for all enterprises and organizations manufacturing or developing drugs, regardless of their territorial location and departmental affiliation.
The shelf life is an integral indicator of pharmacopoeia articles developed and approved in accordance with OST 42-1-71.
1.2. Under the shelf life of drugs means the time during which drugs must fully satisfy all the requirements of pharmacopy articles or temporary pharmacopy articles ( technical Conditions) According to which they were issued and kept.
1.2.1. The shelf life of the drug is established experimentally during storage for a certain time and, as the data accumulates, it can be changed both towards zoom in and up to the reduction.
1.2.2. In cases where the drug changed the quality indicators regulated by the regulatory and technical documentation (see 1.2.) Before the expiration of the established expiration date, the consumer has the right to make a claim to the manufacturer, as for the supply of low-quality products (marriage), but no later than 3 For years after the delivery of products. At the same time, the consumer must confirm that they were followed by the prescribed regulatory documentation for the storage conditions of the drug.
1.3. The initial shelf life of the drug defines the developer's organization when preparing a draft temporary pharmacopoeia article.
1.3.1. The change in the expiration of drugs is carried out as a change in the regulatory and technical documentation and is issued according to OST 42-1-71.
1.3.2. The initial date of expiration date of the drug is taken by the date of the permission of the enterprise's deletion on its release.
Shelf life medicinal norms Set regardless of the expiration of the main substance.
For the manufacture of ready-made dosage forms, only those drugs whose established expiration date has expired not more than on:
For medicines with an expiration date of 3 years - 20%;
For medicines with a shelf life of over 3 years - 30%.
This OST does not provide for the procedure for determining the sessions of drug storage in warranty reserves.
Storage time in warranty reserves are established taking into account the possibility of selling medicines before the expiration of their expirational terms.
1.4. The conditions for storing medicines prescribed by regulatory technical documentation should be respected not only during storage, but also during transportation and during the sale. Special conditions for the storage and transportation of the drug must be specified when labeling packages and containers.
2. The procedure for determining the initial shelf life
Drug
2.1. Work on the determination of the expiration date of the drug The developer starts at laboratory samples at least 6 months before the transfer of the drug for clinical trials.
2.1.1. The determination of the expirational periods should be based on the study of the stability of the drug using chemical and physicochemical methods of analysis specified in the general articles of the current state pharmacopoeia of the USSR, as well as if necessary special methods Research (for example, biological analysis methods, pharmacological tests).
2.1.2. The study of the stability of medicines should establish the most harmful influences external factors (High or low temperatures, interaction with moisture, oxygen and other air components, photosensitivity, etc.) depending on the time and conditions of their impact.
At the same time, it is necessary to determine:
a) the degree of changes in physical and chemical properties medicinal product ( appearance, melting or boiling point, chemical composition or percentage of components, etc.) when heated and cooling, when interacting with air and its components, when exposed to direct and scattered light.
Notes:
1. The list of drug properties and a list of the most harmful external factors that are investigated when studying stability determines the developer's organization, which may also adopt the special physico-chemical and analytical characteristics of the samples studied (spectral, radiophysical, chromatographic, etc.) in line with With the general articles of the current state pharmacopoeia of the USSR, and if necessary, additionally use other methods (for example, for antibiotics, biological methods of analyzes and pharmacological tests).
2. In the study of stability dosage form It is studied both the stability of the main substance and its compatibility with the components included in the dosage form.
b) hygroscopicity of the drug;
c) toxicity or other indicator of harmful physiological impact on the body.
The results of studies of the stability of the drug are treated and represent either in the form of mathematically pronounced functional dependence, or in the form of graphs and nomograms.
If necessary, the study of the dependence of the stability of the drug is organized from the quality of the intermediates of its production.
2.1.3. Based on the study of the properties of the drug, establish the optimal requirements for its container and packaging and storage conditions.
At the same time, the requirements for containers, packaging, tightness, light, lighting, the presence of residual air and its components in the package after capening or sealing, as well as the necessary restrictions on temperature regime storage.
2.2. After establishing optimal requirements for packaging and packaging and storage conditions, the developer's organization proceeds to the experimental storage of the drug in the recommended packaging and under the specified conditions, in order to detect hidden factors that can affect the resistance of the drug three storage. For these purposes, from each series of a specially prepared experimental laboratory sample or a laboratory sample released for clinical trials, a part is selected and collapsed in an amount sufficient to study the stability of the drug during storage within 2-3 years.
In the preparation of materials for the shelf life of the drug for the draft temporary pharmacopoeia article, the developer's organization is guided by the OST 42-1-71 and conducts experienced storage until the release of the drug in the industrial series.
2.2.1. Experienced laboratory and semi-produce samples of drugs on study are subject to analysis every 6 months in all indicators of preliminary (copyright) technical conditions, and in the future, according to the approved regulatory and technical document (WFS, FS).
2.2.2. The storage of prototypes of the drug in the study of its stability should be carried out in that packaging and in those conditions that are determined by paragraph 2.1.3.
2.3. The results of studies of the stability of drugs are reduced to the table.
Table Stability Research Table
medicines
NN. |
Drug |
NTD. |
View |
Time |
Time |
Time |
Condition |
Resultery |
date |
Rend |
conclusions |
2.4. On the basis of experimental materials, an organization that studies the stability of the drug determines the initial shelf life indicating the required storage conditions, the type of packaging and transportation and makes this data in the WFS project.
Materials substantiating the shelf life are submitted to the USSR Ministry of Health at the same time as the WFS project in accordance with the OST 42-1-71.
2.5. Organizations leading to the study of the stability of drugs and representing materials in terms of their shelf life are responsible for the established expiration date as well as for the development of regulatory and technical documentation.
2.6. After the organization of industrial production of medicines, all work on the study of the stability of drugs on the industrial series is manufactured by the manufacturer, and the developer organization transfers all available materials and provides him with scientific and methodological assistance.
3. The procedure for studying the stability of medicines
In production conditions
3.1. All enterprises and organizations in the preparation of the mass production of a new drug in the development of experimental regulations should organize research to study the stability of the drug and clarifying the expiration date for making recommendations to the FS project. Works on clarifying the shelf life of the drug continue during the production of industrial series.
Note. Study of the stability of drugs previously mastered by industry, but not having installed deadlines The affinecies are carried out in accordance with the provisions given in this Sectoral Standard.
3.2. Work on the study of the stability of the drug should be organized in the CZL or other division by order or order of the head of the enterprise or organization.
To keep this work, a responsible performer is prescribed.
3.2.1. Work on the study of the stability of the drug should be included in the plan of research and experimental work.
3.3. Control over the quality of the drug in the storage process and its storage conditions must comply with the regulatory and technical documentation on which it was released.
3.4. Packaging and packaging of the studied drugs must comply with the requirements of the regulatory and technical documentation on which drugs were issued.
3.4.1. With commodity packaging of medicines in large-dimensional containers (bags of paper 3 and 4-layer, iron barrels, tin drums, flasks, bottles, etc.) To study stability, the use of similar containers of less capacity sufficient for modeling is allowed .
3.5. To study the stability of drugs, samples of 5 industrial series should be taken in an amount sufficient to carry out required analyzes During the five-year term of observation, and for bapparers - from 10-15 episodes.
From each sample of the drug for periodic analysis, only one sample is selected. In the future, these samples are not used.
3.6. In the event of a significant change in the production of drug production (change in the types and quality of raw materials, drying, cleaning, crystallization modes, etc., for example, for antibiotics - a change in the strain of producer and a nutrient medium), this drug is compared in accordance with paragraph 2.1. 2. and 2.2.1. With the same drug indicators issued by unchanged technology.
3.6.1. The drug issued by modified technology is subject to testing in accordance with paragraph 3.5. and 2.2.1. Only in case of the discrepancy of its properties by paragraph 2.1.2. With the properties of the sample released on the old technology.
3.7. Before laying on storage, all drugs are complete for all indicators in the scope of the requirements of the current regulatory and technical documentation with the record in the stability research results table.
Notes:
1. With subsequent checks, indicators that cannot change during storage are not determined (for example, the content of sulfate impurities, chlorides, etc.).
2. For all indicators of the current regulatory and technical documentation, it also produces an inspection in cases:
Detection of deterioration of the drug during its storage;
When preparing materials to extend the shelf life.
3.8. When bookmarking the storage of medicines in the form of tablets, dragee, ampoules, ointments, suspensions, capsules, etc. It is necessary to take into account the time of the manufacture of basic substances. Data on the time of manufacturing of basic substances is brought into the table of the results of research stability of medicines.
3.9. Drug samples that are on learning are subject to verification in the following dates:
Under the expiration date on the regulatory and technical documentation for up to one year every 3 months;
Under the shelf life of 3 years every 6 months;
Under the shelf life of more than 3 years - after 12 months.
4. Storage conditions for samples when studying stability
4.1. Drug samples selected for studying stability should be kept in a special room or placement of the warehouse separately from other products in the workshop package on pallets or racks.
Drug samples of the list and should be stored in special conditionsDefined by order of the USSR Health Minister of July 3, 1968 N 523.
4.2. Hydrothermal conditions warehouse Must meet the requirements of the current regulatory and technical documentation.
In the absence of recording instruments, the temperature is determined using a thermometer with a scale from -50 degrees. up to + 50 degrees.
Instrumentation must be installed in the center of the room at an altitude of 1.5 m from the floor and removed from heating devices and doors at least 2 m.
The luxmeter should be accommodated next to the test samples.
Measuring the illumination with a luxmeter is advisable only in cases where the packaging material is transparent and does not protect the drug from the effect of light.
4.4. The temperature and humidity indicators of the warehouse room must be logged in the log below.
Indicators of temperature and humidity of the warehouse
date |
Time |
Temperature, |
Relative |
Illumination B. |
Note |
||
10 h |
12 h |
16 h |
|||||
5. The procedure for issuing and presenting reporting
Materials on the work carried out
5.1. The organization (enterprise) is a developer in accordance with the OST 42-1-71 comprising proposals for the establishment of the terms of the expiration of the drug to all types of regulatory and technical documentation:
WFS, FS, depending on the development stage and introduction of the drug.
In an explanatory note to establish the expirational time, the rationale for the correctness of the selection of containers, packaging and storage conditions and transportation is given a summary of the analytical data in accordance with the table (clause 2.3) confirming the proposed shelf life of the drug under the conditions provided for by paragraph 2.4. This standard and data of the hydrothermal regime and lighting of warehouse.
5.1.1. The analytical data table and the explanatory note must be signed by the head of the developer's organization.
5.2. Industrial enterprises that study the stability of drugs, starting from the bookmark of industrial series of new drugs, must submit a basic organization for standardization and metrology at least once a year, a report on the work carried out, as well as a report on the study of the stability of products with the accompanying letter, signed by the company's head.
5.2.1. Report on the expirational work should contain conclusions and suggestions that are informed by the analytical data in accordance with the table of the results of research results of medicinal stability confirming new term the shelf life or inappropriateness of further study of the stability of the drug, as well as recommendations on clarifying or changing the types of containers and packaging, the conditions for storing and transporting caused by the introduction of new progressive technological processes or the use of new types of raw materials and materials.
5.2.2. The proposals of enterprises and organizations to change the terms of suitability must be issued in the form of a statement of changes to the current regulatory and technical documentation and are presented in the basic organization on standardization and metrology, which in 3 monthly time Considers them together with the conclusion about the feasibility of changing the expirational terms, it sends to approval in the prescribed manner in the Office for the introduction of new drugs and medical equipment of the Ministry of Health of the USSR.
5.2.3. Information about making changes to the regulatory and technical documentation for shelf life is carried out in the prescribed manner.
Head of Department
for the introduction of new
medicines I.
medical equipment
Ministry of Health of the USSR
cand. honey. Science
E.A. Babayan
Chairman
Pharmacopoeia committee
chL-Corr. AMN USSR, prof.
M.D. Mashkovsky
Scientific Secretary
Pharmacopoeia committee
cand. Farm. Science
A.N. Omericmakov
Head of Technical
Department of Minedprom
D.X.Skalaban
Department head
standardization
metrology I.
scientific and technical
technical information
Department of Minedprom
N.G. Fedorov
The Association assists in the provision of services for timber: at competitive prices on an ongoing basis. Forest products of excellent quality.