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MANAGEMENT

Є.B. Zhyburt, MD, DSc, Professor, S.R. Madzaev, Ph.D.

FSBI "National Medical and Surgical Center IM. N.I. Pirogov "Ministry of Health of Russia

To drive the new pharmacopoeial statistics

"PLASMA OF PEOPLE FOR FACTIONS"

The blood plasma of people is to take revenge on the richness of blood, as they see, cleanse and include in drugs, which may be of great importance. Otrimanie with plasmas produce life, and even a few plasmas for fractionation are surrounded by a few donors. On the 1st of June 2016, she entered the pharmacopoeia of the statute "Plasma of people for fractionation." Tsikavim є Assessment of the validity of the pharmacopoeial statistics (FS) of the practice of the Russian blood service, as well as the analysis of the analogous monograph of the European Pharmacopoeia.

A critical analysis of the new pharmacopoeial statistic, allowing a number of inadequacies to emerge. Vichiznyany FS has a lot of ballast slavs. For example, in the distribution "Donory" I will mention the phrase "For blood plasma testing of people, the plasma of healthy donors can be obtained from vicoristan. : "Plasma of the blood of people will be recognized from donors, from various sources to the extent of any other normative legal acts." Vikoristovuvaniyu in FS the term “one plasma unit” is a whole translation of the English term “plasma unit”. In Russian, they say “dose of plasmi”. Serious grave - interchanging the methods of screening serological markers for infections up to one enzyme-linked immunosorbent assay. For the whole of Russia, there are three more immunological methods regulated for the whole family: immunochemistry-percentage analysis, passive heme-hygiene and principles. If it is formal, then it is impossible to find the laboratory of "Rosplasma" donors on the possession, purchased within the framework of the national project "Health".

Key words:

plasma, donor, fractionation, treatment, infections

Keywords: plasma, donor, fractionation, examination, infection

The article evaluates the conformity between the new pharmacopoeial article "Human plasma for fractionation" and functions of the Russian Blood Service; there is a comparison with the corresponding monograph of the European Pharmacopoeia. The authors conclude that the following changes should be made in the new pharmacopoeial article: cancel: restrictions on methods of screening for infection markers, requirement for compulsory plasma quarantine, species-specific tests, test for specific activity in the production of normal immunoglobulin. E.B. ZHIBURT, MD, Prof., S.R. MADZAEV, MD, National Medical and Surgical Center named after N.I. Pirogov, MH RF. ON THE NEW PHARMACOPOEIAN ARTICLE "HUMAN PLASMA FOR FRACTIONATION."

Plasma can be used to obtain vicoristan for blood preparation or transfusion of the recipient for wisdom in the activation of pathogenic biological agents.

Nezumuly vimogu to the water of donors with "specific and nonspecific markers of infection". So also "nonspecific marker of infection"? Prior to specific markers of infection, carry antibodies such as anti-HBs. Їх manifestation is the blessing and mind of rejecting immunoglobulin. Why should I have such a plasma? Primus's quarantine-tsiya is evil, and some of it will lower our competitiveness. Zagadkova phrase: "Before the formation of a viral pool (entangling), individual units of plasmas must be combined for conducting a vip test for demonstrators." Another grave is to interconnect the technology of amplification of nucleic acids from pathogens by one method of polymerase lanceolysis. For example, the method of amplification, mediated transcription, which is stagnant in Russia, in the series of viprobuvan, showing a greater sensitivity.

Viklikak was inspired by the fact that there are two types of green plasmas in the two common propositions: zhovty and greenery. The assessment of the reliability of plasmas for fractions of anti-tough blood of people, great horny thinness, horses and pigs is amazingly proponent. In the European Pharmacopoeia, there is no such vimogi.

TO THE DRIVE of the pharmacopoeia of the statute "PLASMA OF PEOPLE FOR FACTIONS"

The Russian organization of the blood service is able to clean only with people, to make sure that the skin dose is stitched. Volodya needs my own imagination to imagine the great horned thinness, Horses and pigs in the donor halls of our blood transfusion stations.

At the “Specific Activity” section, it seems absolutely necessary to take vimog for virobniztv preparations for immunoglobulin of people of normal vkazuvat in the place of antibacterial antibodies (minimum against one antibiotic) The price of non-rational (bezgluzdі) tightened up to the last (most wondering anti-til to the (be-yakim!) Bacteria and virus?). The whole paragraph is required to be seen. On our glance, the last seen and distributed "Virusna bezpeka" (funny inclusion of syphilis in the whole lot), the underdeveloped duplicate vimogs, transcribed in the "Individual single plasmas" distribution. It is unambiguously necessary to formulate how the donor's shelter is available during the donation process, and not a container with prepared plasma.

Before the markup of plasmas, it is necessary to bring the conformity to the national standard.

Writing "Antibody to VIL-1, VIL-2, to hepatitis C virus, that surface antigen to hepatitis B virus in daily life", which is to be taken on plasma, so on ready-made blood preparations, is our hanba. To go viral, they can be violated, but they were breaking only banal, absolutely without glut (no p24 antigen, no NAT). On the basis of the European Pharmacopoeia, the vitality of the pharmacopoeial statistics does not indicate the sensitivity of molecular biological methods, as the value of natural nucleic acid inhibitors is not transferred.

An analysis of the new pharmacopoeial statistics has shown that there is a need for serious management.

On the other hand, it is necessary to introduce such changes into the new pharmacopoeial statute - for the integration of methods for screening markers for infections, for the generalization of viscous plasma processes, for the activity of specific tests, for specific tests. ^

JERELA

1. Order of the Ministry of Health of Ukraine No. 768 on 21 leaf fall 2014 to the rock "About the hardening of foreign pharmacopoeial monographs and pharmacopoeial monographs."

2. Human plasma for fractionation. 07/2008: 0853. European Pharmacopoeia 7.0: 2181-2182 (http: //180.l68.103.34: 7947 / zl / EP7 / 0853E.PDF pitched on 02.11.2015).

3. Decree of the Uryad of the Russian Federation dated 31st December 2010 p No. 1230 "About the consolidation of the rules and methods of blood supply, and trans-fusion-infusion therapy ".

4. Laboratory for serological screening of donor plasmas, m Kirov / http://www.ros-plasma.ru/galery/index.php?id=66 (camped on 26.10.2015).

5. Decree of the Uryad of the Russian Federation dated 26 September 2010 r No. 29 "On the consolidation of the technical regulations for the protection of blood, products, blood problems and technical problems, and how to be treated in transfusion -infusions."

6. National standard of the Russian Federation GOST R 52938-2008 “Donor's shelter and components. Container with canned blood or components. Markuvannya ".

7. Zhiburt Є.B. Corruption of components in blood preparations. Remedium, 2004, 11: 56-57.

8. Zhiburt Є.B. Adoption of virus-free blood preparations. Zap. Virology, 2004, 49 (4): 46-48.

Besides ...

In the field of electronic marketing of leaks in Russia, take care of the Federal Tax Service

First Vice-Premier of the Russian Federation Igor Shuvalov completing the Federal tax service(FPS) in the system of electronic marketing (W-met-ki) drugs, as well as virobiv easy industry and food products for identification and fight against a contra-fact. Winning, I’m not talking about the test mode, but about the widest possible range of new systems and the most sensitive in the minds of the category of goods. The project for the implementation of the state system and monitoring of health care products, for the transfer of individualized packaging of drugs, for the release of the Ministry of Health Protection from the past fate. The additional decision will allow to simplify the procedures in case of re-distribution by parties of LZ cordons of the Russian Federation, as well as to expedite the introduction of counterfeit and falsified products on the internal market.

The Ministry of Health is ready to allow sales of medicines in supermarkets

The Ministry of Health Protection has approved a draft law on the implementation in distribution of food trade stocks of an intermixture of drugs. As a matter of fact, about the cob of robots above the document, it has been placed on a single portal of drafts of normative legal acts. The Ministry of Finance proposes to make a number of changes in federal laws"About the beastly lykarsky zasobiv"№61-ФЗ and" About the licensing of the environment "№99-ФЗ. At the passport, the bill will be issued, which will be distributed according to the instructions of the first vice-premier Igor Shuvalov. Meals about the possibility of realizing certain categories of non-prescription drugs in grocery stores is repeatedly discussed in the chain of the last few rocks. The Ministry of Health Protection, as well as representatives of the union of pharmacy fencing, played against the initiative.

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Human plasma, designated for fractionation, is divided into 3 categories. Plasma of the 1st and 2nd categories should be used for preparation of factor VIII and factor IX, plasma of the 3rd category - for albumin and immunoglobulin (Table 3). The assigned categories of plasmas are developed according to the peculiarities of plasma removal and freezing terms for blood donors, according to the specified temperatures and freezing and recovery, according to the terms of plasma recovery and availability, after an hour of delivery. To the plasma of the 3rd category, it is not only the plasma that can be transferred from the whole blood, but the plasma, when taken into account and transported, which meant destruction temperature regime... This is called recovered plasma and is an additional source of stable protein components - immunoglobulin and albumin.

The quality, standard and safety of plasmas for the production of drugs in accordance with the pharmacopoeial standard. Most of the European Territories of the National Pharmacopoeia. The European Pharmacopoeia is designated for the establishment of a single pharmacopoeial space for the countries of the continent, such as to push back to the mutual integration of economy, protect health, and industry within the framework of the European Union. In 2002, it was published by Vitchiznyan Pharmacopoeia Stattya 42-0091-02 "Plasma for fractionation" Russian virobniks drug in plasmi. The release of the updated pharmacopoeial statutes (FS 42-0091-02) "Plasma for fractionation" from the European Pharmacopoeia has appeared, so that correctives can be added to the document.

Perche, not primed, surrounded by ways of removing plasmas. It is necessary to be aware that a part of plasmas (close to 10%) is seen in the Blood Service for spontaneous collection of cells. In addition, to finish up with hundreds of plasmas, so that you get lost in the picture of the cryoprecipitate. It is fundamentally important to vikonuvati taku vimogu, as safe freezing of plasmas from the whole blood, from rinse plasmapheresis, followed by precipitation. The mode of freezing and collecting plasmas should be injected in the vicinity of the FS, some of the stench lie in the form of plasmas - the removal of stable abnormally labile fractions of plasmas.

With an important mind, a reference to those who are guilty of plasma is responsible for the fractionation only in an individual primary flask or a plastic container from one donor, who is guilty but is monitored for the integrity and authenticity of the identity. Identification of the skin individual container with plasma can only be provided on the label and accompanying document, by proper execution and registration by a person, legally valid for the registration of plasma. Danih, meaning on the etiquette is just enough, just let the plasma go to virobnitstva or send it to the dispensary.

The quality and standard of the selected plasmas should be carried out in the same position as a set of problems, however, the transfer of FS 42-0091-02 to the set was inadequately assessed in the general discussion on the basis of the alleviation of the skin technology. vimagan non-primed and one hundred economical deposit. A number of dosages (tests for penetration, color, pH, blocks) can be carried out by adding plasmas to a closed (pool), it is more important to test for a virus security guilt that only plasmas are taken into account. It is necessary to maximize the speed of an hour from the moment of freezing plasmas to the ear of the technological process.

The current term in our country for the acquisition of frozen plasmas by a stretch of 1 rock, 2 times less, below the cordon, the term of the acquisition of plasmas is carried out by a stretch of 2 rock. Reduce the terms of plasma preparation to reduce the cost of plasma preparation.

In the European standard and other international documents, it is stated that the temperature at which the plasma is carried out is 10 degrees lower and becomes -20 ° C or lower. It’s not easy for you to buy more expensive equipment, more electrical energy. To that, the temperature has been adjusted by 10 grams. There will also be a decrease in vitrate for the procurement and recovery of fresh frozen plasmas and the speed of feeling the rate of obsolete products with plasmas.

Otrimaned and re-insured recommendations allowed the development of a form of information sheet, agreement, specification of quality and documentation, such as part of the agreement, but also as a legal document, but on the basis of the validity of the validity of the post

shosta chapter"Safeguarding virus-free donor plasmas" revealed the role of conducting visits, directing them to healthy freeze-frozen plasmas. Blood products that have been poured to patients may be infected with germline infections, which are not safe for life and the middle most serious ones - HIV infection, hepatitis, hepatitis C virus infection, hepatitis B (HBV)

To ensure the protection of donor blood, the components and preparations in the bullets of the disseminated propositions, which include a complex of visits from the provision of donors and blood included before the Order of the Department of Health Protection in Moscow, No. 513 born on November 29, 2007 the risk of development of post-transfusion infections ", which is compulsory up to the date of robots with donors at the blood transfusion station.

They are not indifferent to those who, when collecting plasmas with the help of a lazy mind, the donor's care and the donor’s material, in general, in the case of a virus, no matter what, the reason for the donation’s mind of a fake donor’s proof of the donor’s health is that they don’t care. at a temperature of -30 ° C, so there is a possibility of using plasma images when there is adequate information about the donor's incapacitation, who were treated in the seronegative period of virus infection at the time of donation.

However, the donor donors do not expect to come for repeated donor treatment for repeated donor treatment. Otrimanie danis, so chorically through the failure of donors to be re-covered in the middle of the day, 1605 liters of plasmas are taken, and in the middle of the day, 3500 - 3600 donors are in quarantine. I will look at the number of liters equivalent to 12,485 doses of plasmas, then for one patient, in the middle 3-5 doses of plasmas, approximately 2,497 - 4,162 patients do not take the necessary for drinking purposes plasma і її drugs.

Freezing of selected plasmas and freezing of vitrats. I’ll look at the surroundings, it was completely and justified directly by quarantined plasmas from donors, but they didn’t come for a second checkup, for activation and seeing viruses, be it from the permitted methods. In the present hour, the methods for the activation of viruses are possible to end up with a lot, even if it is permissible for the deprivation of deyak from them. For ciches, use a heat treatment, a cleaning agent and detergents, a photochemical method. The most suitable method for the inactivation of frozen plasmas is the S / D method (solvent-detergent processing of plasmas). Є great practical knowledge of the disease for the processing of large quantities of plasma and reliable data about the effectiveness of the injection on HIV infection and the virus of hepatitis B and C. The need for plasma inactivation for transfusion

A trace of memory, so the activation of viruses is a definite procedure, the efficiency and the shortness of which for plasmas are to be guilty of, however, has been adjusted to a certain extent. The effectiveness of seeing as well as the activation of viruses is because of their intercourse and, in any way, the procedure is a compromise between the building of knowledge of the virus and the need to eliminate the negativity of the inheritance. That is why all the methods to supplement the process of selection and screening of donors, but do not suppress them.

The quality, standard and safety of donor plasmas can be met by the insane regulations governing documents when procurement of donor and donor information.

V somomu razdilі"The concept of reforming a high-quality viral preparation in plasmas" has known its own image of such nutrition, as a structural-management approach to organizing viral preparations from fresh frozen plasma, an algorithm for optimizing

An analysis of the published materials will show that the production of preparations in donor blood in our country is quite often based on the production of blood preparations, the preparation of preparations in the blood is ineffective in technological and economic terms. The blood plasma of donors is vikorized during the processing of 30-40% of the dietary capacities through the daytime at the enterprises of modern technologies and possession. On one side of the skin liter of processed plasmas through not so much of її ї ї ї ї ї ї ї ї ї ї ї ї ї і ї і ї ї ї ї ї ї ї ї ї ї ї ї ї ї ї ї і ї ї ї ї ї ї ї ї ї ї і ї ї ї ї ї ї і і ї і ї і ї і ї і і і і іnototimannya product is spent nearly 6 000 rubles. in the market for light prices, and from the other side in the country, hundreds of millions of dollars are regularly spent on the import of vital medicines from the blood, which are lacking for effective treatment.

At the Russian Federation, in a given hour, you should set the required capacity to recycle plasmas of 200 liters. up to 30,000 liters. on pik. Smells are found in the warehouse of the Blood Transfusion Station, or as an independent enterprise. For їх functions required values ​​of the cost. At the same hour, the profitability of such virobnities is unfortunate, since the stench cannot preserve the technological process with standard installations and modern technology, Qualified personnel.

In all, the whole world is to promote the concentration of virobniztv drugs, so that it allows you to reach high economic efficiency with minimal technological costs and high quality and viral safety of products. For NAUKOVO obґruntuvannya іnvestitsіy i organіzatsії pіdpriєmstva vіdpovіdnoї potuzhnostі neobhіdno spend doslіdzhennya Bulo, scho dozvolyaє bring, scho for samozabezpechennya Kraina plasma preparations i krovі, dosyagnennya nalezhnogo rіvnya yakostі, visokoї efektivnostі virobnichoї pererobki plasma rentabelnostі virobnitstva that realіzatsії lykarsky zasobiv it is necessary to establish the great virobnicheskie enterprises, which can be used with modern technology for fractionation of large plasmas.

At the dissertational prestigious vikoristan "Methodology for the commercial evaluation of investment projects" UNIDO (UNIDO - United Nations Industrial Development Organization - special established by the United Nations, by means of how to develop industrial development). This technique has become the first systematic wikklade in Russia, and it has become a common practice for modern people to understand and evaluate tools for investment projects, as well as key nutrition in the Russian macroeconomic situation.

To take the decision about the investment in the capital, the capital needs mother information, in this case there are two main surpluses:

• the contributions of the most guilty but on the basis of the attribution;
• The arrival is guilty but it’s big, but it’s worth compensating for the team’s vidmovu from the victorian cattle, as well as the rizik, which is the winn’s due to the lack of value to the final result.

To take a decision about investment, then evaluate the plan for the development of the project from the point of view of how much the project will change and the inheritance of the result.

At the same time, using the Bull methodology, an assessment of the effectiveness of investments was carried out for the onset criteria:

• investment to the project,
• simple methods of assessing efficiency,
• discount methods,
• clean and precise partnership with the project,
• internal rate of arrival,
• the official's account of non-value and assessment of the risk

Carrying out the technical and economic reorganization of investments made it possible to raise the need to protect the health of the Russian Federation and Moscow in preparations and to make sure that the plasma was recycled for them. It has been established that it is necessary to run 4-5 day-to-day virobnicheskie enterprises with a skin strain of at least 200,000 liters of plasma fractionation per week (Table 4).

Otrimanі, when developing a business plan, the results are to ensure that vitrati on the stem of the cob circulating capital can be considered for the development of budgetary financing on a non-revolving basis. In general, the state budget for the project is 62% of the total budget for the project.

Table 4. Requirements for plasma preparations of residents of Moscow, the Moscow region and the Russian Federation and cleaning of finished products when processing 200,000 liters. plasmi in pik

37. (6.6) Be mindful of securing and transporting blood or plasmas to the enterprise from the fractionation of the guilt and documentary registration on all stages of the lancer production. The establishment of the fractionation needs to be aware of whether the temperature is set. It is necessary to victorious possession, as passed the qualifications, and procedures, as passed the validation.

Assessment and granting of permission for the release of plasmas for fractions

38. (6.7) A dose for the release of plasmas for fractionation (quarantine) can be carried out only after additional systems and procedures, which will ensure the quality required for the production of finished products. Plasma can be supplied to the enterprise from the fractionation of a certain type of documentary confirmation by a certain person in the existing agreements, as well as in all stages of the boule carried out in accordance with the rules.

39. (6.8) Victory of all containers with plasma for fractionation when needed for the facility with fractionation is allowed by a trustworthy person. Upovnovazhena person guilty pіdtverditi scho plasma vіdpovіdaє vsіm vimogam pharmacopoeia articles State farmakopeї Rosіyskoї Federatsії and takozh zadovolnyaє Minds vіdpovіdnogo reєstratsіynogo dosє, in addition chislі main dosє plasma Abo razі vikoristannya plasma for programs fraktsіonuvannya for the contract for tretіh kraїn vsіm vimogam, peredbachenim point 9th Dodatka.

Plasma processing for fractionation

40. (6.9) The stages of the process of fractionation are developed as fallow products and wines. As a rule, the stench includes various operations, and some of them can be sensitive to activation or even more contamination.

41. (6.10) The guilt was due to the establishment of the patient before the processes of processing, collection of samples from common plasmas, fractionation and inactivation, for example, the viruses that need to be removed.

42. (6.11) Methods for getting vicious in the process of viral inactivation, it is necessary to fix it from the suvorim of the previous procedures. Such methods are guilty of adapting methods, such as bully vicoristani during the valuation of procedures for virus activation. We carry out a retreat of all small procedures of virus activation. Adopting a valid technological process є is especially important in procedures for reducing the number of viruses, some of them can become risky for the safety of finished products. They are guilty of the obviousness of the procedure, which is responsible for the importance of risky.

43. (6.12) If I repeat the processing, or it is possible to process the processing only by making calls to the management of risers for quality and only at the singing stages of the technological process, as well as in the applicable industrial regulations.

44. (6.13) A system for a clear submission and (or) distribution of drugs in or industrial products, which have passed or have not passed the procedure for reducing the volume of delivery, has been organized.

45. (6.14) Regarding the result of the retally carried out process of management of the risk factors (including the available information in the epidemiological data), it may be allowed to carry out the process based on the principle of cyclic plasma cycles in the form of a single product. the opportunity and the manifestation of the established validated cleansing procedures. For such visits, they are guilty of being guilty on the general regulatory legal acts of the Russian Federation. During the additional process of managing the workers, we have been informed about the need for special possession in the implementation of the program of the agreement with the third countries.

46. ​​(6.15) The term for securing industrial products, designated for securing, must be established on the basis of stability data.

47. (6.16) The fault was established and documented before the purchase and transportation of industrial products and ready-made drugs for all stages of the delivery. It is necessary to victorious possession, as passed the qualifications, and procedures, as passed the validation.

VIII.YACOST CONTROL (7)

48. (7.1) Vimogi before viprobauan on the virus or because of the information of the agents who are guilty of the new knowledge about the information of the agents and the manifestation of the validated methods of viprobauan.

49. (7.2) The first single-sided pool of plasmas (for example, when the federal government reports on the basis of plasmas), it is necessary to control the validity of the validated methods with the proper sensitivity and specificity of the pharmaceutical industry.

IX... VISUAL VALUE FOR VISA

PROMIZHNOЇІ finished products (8)

50. (8.1) May be allowed to release the release of such serii, such as viroblency from plasma bullets, determined as a result of control by negative markers foreign infections, Transmitted through the roof, as well as in accordance with the guidelines of the pharmacopoeial articles of the State Pharmacopoeia of the Russian Federation (including whether they are special boundaries, which are surrounded by different viruses) and hardened plasma specificities, basic documents.

51. (8.2) Granting permission for the release of industrial products, designated for the general processing of the whole maidan in the middle of the virobniche, and also granting the permission for the release of ready-made medicinal preparations for the production of new products.

52. (8.3) A person has been instructed to be guilty of granting permission for the release of industrial or ready-made products for the program of fractionation for a contract for the third countries, on the basis of the regulations, the civil society with the assistant, as well as such Even so, these drugs are not approved for storage in the Russian Federation, before they may not have been stored in the pharmacopoeial articles of the State Pharmacopoeia of the Russian Federation.

X... ZBERIGANNYA ZRAZKIV bullet plasmi (9)

53. (9.1) One pool of plasmas can be used for viral production of decalcine serii and (or) drug preparations. Control examination of the skin pool of plasmas, as well as of the reported records of the blame for at least one fate, for the termination of the term of removal of the drug taken from the pool of the drug with the greatest term of the drug for the preparation of certain drugs,

XI.VIDALENNYA VIDHODIV (10)

54. (10.1) It is necessary to solidify the procedure for the non-fired preparation and visualization of thermal preparations, disposable and rejected materials (for example, contaminated ones, some of the information donors, as well as blood products, plasma documented.

Dodatok number 15

prior to the Rules of organization

and control of the quality of the lykarsk workers

KVALIFIKATSIYA І VALIDATSIYA

I. PRINCIPLE

1. For the purpose of a complete supplement of victories to the qualification and validation, storage to the licensing of medicinal preparations. Using the method of verifying the availability of parameters in critical processes (possession), the vimogs are responsible for carrying out the assessment of processes and possession, as well as being vicious in the process of detecting likars. Validation is also carried out when there are a lot of changes in the processes, possession and processes, which can be influenced by the quality of the product. For the purpose of making a warehouse and a job according to the validation, it is necessary to register the documents for the evaluation of the documents.

II. PLANNED VALIDATION

2. All the validity of the validation is necessary to plan. The key elements of the validation programs must be clearly identified and documented in the main validation plan or similar documents.

3. The main plan of the validation can be considered as a common document, put in a laconic, precise and clear form.

4. The main plan for the validation of mystity, zokrem, I will come with information:

(A) meta valuation;

(B) organizing the scheme of activity with validation;

(C) the transformation of all primitives, systems, possession of and processes that support the validation;

(D) a form of documentation for the form, as it should be for the records and calls;

(E) the plan for that graph of the announcement of the robot;

5. In the case of great projects, there may be a need for folding around the main plans of valuation.

III.DOCUMENTATION

6. It is necessary to break up the written protocol from the orders, in addition to the order in which the qualification and valuation will be carried out. Such a protocol can be used for inversion and hardening. Critical steps and acceptance criteria are specified in the protocol.

7. Most of the preparations are due to the perehreshnyh on the protocol of quality and (a) validation, so that the results are disclosed, so that comments should be taken away, I would like to improve the results and recommendations, include Whether changes are included in the plan, which are indicated in the minutes, it is necessary to draw up documents with the appropriate information.

8. For the successful completion of the qualification, it is necessary to issue an official letter for the transition to the upcoming stage of qualification and valuation.

IV.KVALIFIKATSIYA

Qualification of the project

9. The first element of the valuation of new applications, systems, or the possession and quality of the project.

10. It is necessary to show and document the relevance to the draft of the rules.

Quality installation

11. Qualitative installation is required for new or modified applications, systems and possession.

12. The quality of the installation is guilty of including the offensive elements (or not interconnecting them):

(A) revision of the installation of the equipment, pipelines, auxiliary systems and adaptations to the suitability of the hardened project, including technical documentation, armchairs and specifics;

(B) an assessment and provision of instructions of the supervisor for operation and robotics, as well as for technical service;

(C) an assessment of the amount of money before calibrating;

(D) Reconsideration of materials in the designs.

Qualitative function

13. The quality of the function is to blame for the quality of the installation.

14. The quality of the function is guilty of including the offensive elements (or not being surrounded by them):

(A) viprobuvannya, outgoing knowledge about processes, systems and installations;

(B) testing the functioning of the possession with the working parameters, equal upper and lower permissible boundaries, so that in the minds of the "most important".

15. Successful completion of the qualification of the function of the maintenance of the residual design of the instructions for the calibration, operation and cleaning, carried out by the new operators, as well as the establishment of the assistance to the professional technical service. Only when the deputy mayor can take advantage of the primacy, systems and possession.

Quality of operation

16. Qualification of exploitation will be shown after the successful completion of the qualification of installation and quality of function.

17. The quality of exploitation is guilty of turning on the offensive elements (or not being surrounded by them):

(A) viprobation of materials, which are stagnant in vyrobniztvі, referring substitutes with analogous authorities, or the model drug, broken down on the submission of knowledge about the process, as well as about technical problems, systems or possessed;

(B) Testing with operating parameters equal to the upper and lower permissible limit values.

18. Unimportant to those, which qualification of exploitation can be seen as an okremiy stage robite, in some cases, to carry out thoroughly all at once with a quality function.

Qualifications of the establishment (vikoristovuvanikh)

technical skills, attitudes and possessions

19. It is necessary to give a mother to ground and confirm the availability of critical working parameters to the given vimogs. Instructions for the calibration, cleaning, preventive technical service and operation, as well as the operation of the operators and the maintenance of the guilty parties are documented.

V.VALIDATION TO THE PROCESS

Zagalny vimogi

20. Vimogi that principle, vikladenі in tsyom Dodatka, zasosovnі to virobnitstva lykarsky forms... The stench will expand to the primary valuation of new processes, to the valuation of changing processes and re-hardening.

21. Validation of the process, as a rule, is guilty but completed before the cob of implementation and sale of the drug (promising validation). In vinyatkovy vipadkah, since such validation is not merciful, it may be necessary to carry out the validation of processes every hour of the flow vyrobnitstva (current validation). Processes, which were already carried out for an hour, are also used for validation (retrospective validation).

22. Vikoristovuvanі primіshennya, the system and ustatkuvannya guilty but qualіfіkovanі, and the analytical methods of viprobauvan - valіdovanі. The personnel, who take their part in the conduct of the validation, are guilty of being the only rite of the invention.

23. It is necessary to carry out a periodical assessment of the applications, systems, possession of and processes with the method of confirmation of the robots, as soon as they are assigned.

promising validation

24. Promising validation is guilty of including offensive elements (or not being surrounded by them):

(A) short description process;

(B) the transition of critical stages to the process, which is necessary for the process;

(C) the change of vicarious primitiveness and possession (including the control, restructuring of possession) from the values ​​of the information about the calibrations;

(D) specifics for the finished product upon release;

(E) if necessary, a change of analytical techniques;

(F) proponated control points in the process of adapting and accepting criteria;

(G) if necessary, additional testing, which must be carried out, along with the criteria for the acceptability and validation of analytical methods;

(H) sampling plan;

(I) methods of restoring and evaluating the results;

(J) binding functions;

(K) transmissions of the graphical visitor robot.

25. Behind the help of the established process (vikoristovuchi components, which lead to the specifics), you can create a number of series of finished products with extraordinary minds. Theoretically, the number of vicarious cycles and developmental ones is enough to allow the establishment of certain steps of minority and tendencies, and also to take the necessary amount of data for the assessment. For the validation of the process, there is enough viconati for three last series or a cycle, for which parameters are located in the given boundaries.

26. The size of the serii in case of validation is equal to the size of the serii with the industrial release of the product.

27. As soon as sales are transferred, or if the serii that are violated during the valuation are transferred, then you will be guilty of the revision of the revision to the revision file and to the vimogs of the rules, including the preconditions for the valuation.

sutnya validatsiya

28. In the case of vinyatkovy vypadki it is allowed to repair the serial vyrobnitstvo until the completion of the programs of the validation.

29. The decision about the conduct of a supine validation is primed, documented and approved by persons, as may be more important.

30. Vimogi to the documentation for the supportive validation є such as vimogi, established for the promising validation.

retrospective valuation

31. Retrospective valuation can only be carried out for good processes. Carrying out retrospective valuation is not allowed, even to the warehouse of products, technological process or the recent possession of changes.

32. Retrospective valuation of the meanings of the processes runting on the foreground tributes. At the same time, there is a need for a special protocol and a call, as well as a look at the data in advance of the operation with a view of the application and recommendations.

33. Dzherela tribute for such a valuation may include (or not be surrounded by them) records on the production and packaging of gray products, control pictures of the production, logs of technical service, information about the number of changes in the personnel process, the picture of tendencies, as well as the results of the improvement of stability in case of zberihanna.

34. A series of products, shown for retrospective valuation, may be representative vibrating for all gray, vibrated by a long analyzed period, including all gray, but not specific The number of gray products is guilty enough to bring stability to the process. When a retrospective valuation is carried out, the process can be aware of additional vip tests of archives for the removal of the necessary amount or the necessary type of data.

35. To assess the stability of the process during the retrospective valuation, it is necessary to check the analysis of the data for 10-30 consecutive series, however, if there is evidence of the possibility of a certain amount of

Vi. VALIDATION OF CLEANING

36. Validation of cleaning must be carried out in order to confirm the effectiveness of the cleaning procedure. Ogruntuvannya vibrating between for the transfer of surplus products, missions, as well as microbial contamination can be grounded on the power of stagnant materials. Boundary values ​​of the guilt are real and redefined.

37. For detecting excess or contaminants, it is necessary to obtain validated analytical methods. Interference for dermal analytical techniques is guilty of but sufficient for the establishment of permissible levels of excess or contaminants.

38. As a rule, it is necessary to carry out a validation deprivation of procedures for cleansing the surface of the possession, to contact with the product. However, it is necessary to give respect to the details of the installation, but not to contact with the product. It is necessary to carry out a valuation of triviality intervals in an hour between the end of the process and the cleansing, as well as the cleansing and the cob of the offensive process. They are responsible for the cleansing methods and intervened an hour before the cleansing was carried out.

39. For cleansing procedures, tied with other similar products and processes, it is allowed to vibrate a representative number of similar products and processes. At such vipadkas it is possible to carry out one validation of the preliminaries from the victorious passage "the greatest vipadok", in case of which all critical factors are insured.

40. For the validation of the cleaning procedure, ensure the successful completion of three last cleaning cycles.

41. The method "see until it is quiet, until it is clean" does not replace the validation of the cleaning procedure.

42. If the speeches are seen to be toxic and not safe, then as vintages they can be replaced by vicoristovuvati drugs, which model the physical and chemical power of such speeches.

Vii.CONTROL ZMIN

43. The virobnik is guilty of hardening the procedure with the description, as it is necessary to live, in order to transfer the change of a specific system, components in a product, technological possession, parameters of a variety of different types (or even if there is no way to control it). on the quality of the product or process control. The procedure for the control of changes in guilt to ensure that sufficient amounts of money are not taken away to confirm that the changes in the process allow for the removal of the necessary quality, according to the confirmed specifics.

44. For all changes that can be incorporated into the quality of the product or the process, it is due to the application being filed within the framework of the pharmaceutical quality system. Such allegations have been documented and confirmed. It is necessary to assess the potential flow of changes in applications, systems and set-up for products, including to carry out an analysis of risks. The fault is due to the need and a renewed qualification and repeated valuation.

VIII.REPEAT VALIDATSIYA

45. It is necessary to carry out a periodical assessment of the primitives, systems, possession and processes, including the purification procedures, for the confirmation of the given vimogs. As there are a lot of changes in the daytime, then the substitution of repeated validation to reach the area is called, which informs about those that are attached, the systems, possession and processes lead to the establishment of vimogs.

IX.TERMINI TA VIZNACHENYA

For the purpose of completing the term and value given by Chapter II of the Rules, the following values ​​are also used:

analysis of risks- method of assessment and description of critical parameters during the functioning of the system, or the process in conjunction with the installed security;

validation cleansing- a documentary confirmation of the fact that the cleaning procedure has been hardened to ensure the purity of the possession, which is necessary for the production of licars;

validation of the process- a documentary confirmation of the process, which is to be determined within the framework of the established parameters, it is effective, it is created and produced to the virobability of the drug, based on the specific characteristics;

quality installation- the documentary confirmation of the installation of applications, systems and installation (established or modified) of the versions up to the approved project and recommendations of the virobnik;

quality of the project- documented confirmation of the fact that the proponents of the project are proprietary, possession of any systems є attributable to the storing of the prizes;

quality function- documented confirmation of the fact that the application, the system and that possession (installed or modified) function as a matter of fact, can be obtained in all transmission modes of the robot;

quality of operation- documented confirmation of the fact that the application, the system and the establishment of the system in the case of a spilny vikorystanny pratsyuyuyut effectively and with the established indicators, according to the hardened by the characteristics of the process;

control of changes- documenting the order, the representatives of the new specialties look at the proponents or actually introduced changes, which can be embedded in the validated mill, the possession of systems or processes. The meta of such control is that there is a need for visits, as they are guilty of not protecting and documenting the progress of the system in the validated mill;

modelє drug- material, which for its physical and, if possible, chemical characteristics (for example, viscosity, particle size, pH) is close to the product, which is carried out during the validation. In bagatokh vypadkakh cimi characteristics can be used in the form of a placebo drug (a product that does not take revenge on a pharmaceutical substance);

best vipadok- using standard operating procedures to think about a complex of minds, to be applied to the upper and lower boundary values ​​of the working parameters to the process and related factors to them, which make sense of the majority of the porosity of the product in the process This is not necessary to create a slaughter in the process;

promising validation- Validation, vikonuvana to the ear of a serious production of products, designated for implementation;

revalidation- repeating the validation process to ensure the guarantee that changes in the process and (or) possessed, introduced prior to the control procedure for changes that did not damage the characteristics of the process and the quality of the product;

retrospective valuation- Validation of the serial process of production of realized goods, based on the copies of the data about the production and control of the production of products;

sutnya validatsiya- Validation, vikonuvana for an hour of continuous (serial) production of products, designated for implementation.