of November 3, 2016 No. 83
About approval of rules of conducting pharmaceutical inspections
According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, Articles 6, of 7, 10 and 12 Agreements on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, Items 81, of 83, and the Decision of the Supreme Eurasian economic council of December 23, 2014 No. 108 "About implementation of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union" Council of the Eurasian economic commission solved the 87 and 96 appendices No. 1 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 No. 98,:
1. Approve enclosed:
Rules of conducting pharmaceutical inspections on compliance to requirements of Rules of proper clinical practice of the Eurasian Economic Union;
Rules of conducting pharmaceutical inspections on compliance to requirements of Rules of proper laboratory practice of the Eurasian Economic Union in the field of drug circulation.
2. This Decision becomes effective after 10 calendar days from the effective date of the Protocol signed on December 2, 2015 on accession of the Republic of Armenia to the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, but not earlier than after 10 calendar days from the date of official publication of this Decision.
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Members of council of the Eurasian economic commission: From the Republic of Armenia |
V. Gabriyelyan |
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From the Republic of Belarus |
V. Matyushevsky |
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From the Republic of Kazakhstan |
A. Mamin |
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From the Kyrgyz Republic |
O. Pankratov |
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From the Russian Federation |
I. Shuvalov |
Approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 83
1. These rules establish single procedure for carrying out by pharmaceutical inspectorate of pharmaceutical inspections of production of medicines on compliance to requirements of the Rules of proper production practice of the Eurasian Economic Union approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 77 (further - inspection, Rules of proper production practice).
2. When conducting inspection the inspection team which part are the leading pharmaceutical inspector (further - the leading inspector) and pharmaceutical inspectors is created. When conducting inspection there can be involved experts.
Requirements to the number of inspection team, skill level of employees of pharmaceutical inspectorate and the experts involved inspection team shall conform to the requirements established by the quality manual for inspection of the corresponding type of pharmaceutical production and also the General requirements to the quality system of pharmaceutical inspectorates of state members of the Eurasian Economic Union approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 82.
3. The pharmaceutical inspectorate provides confidentiality of information containing in documents of inspection.
4. Financing of expenses on conducting inspections is performed at the expense of means of the inspected subject or his authorized representative.
5. For the purposes of these rules concepts which mean the following are used:
"the applicant on conducting pharmaceutical inspection" - the inspected subject, the holder of the registration certificate, the applicant on registration or their authorized representative;
"inspection" - stage of pharmaceutical inspection during which the inspection team holds events according to the program of inspection;
"the inspected subject" - the organization which is performing activities for production of medicines and having the permission (license) for such type of activity issued by authorized body of the manufacturing country;
The concepts "pharmaceutical inspection", "pharmaceutical inspectorate" and "pharmaceutical inspector" are applied in the values determined by the General requirements to the quality system of pharmaceutical inspectorates of state members of the Eurasian Economic Union approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 82.
6. Inspections are carried out by pharmaceutical inspectorate according to the plan (schedule) of conducting inspections according to the program of inspection of production of medicines for form according to appendix No. 1 (further - the program of inspection).
Planning of inspections can be carried out according to the principles of risk management.
The plan (schedule) of conducting inspection without fail joins the following data:
basis for conducting inspection;
inspection terms;
the name of the inspected subject;
the address of the inspected production site (further - the production site).
Inspections are carried out in planned and unplanned procedure.
The basis for conducting inspection is the decision of authorized body in the field of conducting pharmaceutical inspections of state member of the Eurasian Economic Union (further respectively - authorized body, state member, the Union) and (or) the statement of the inspected subject (for example, for the purpose of licensing, registration and implementation of other procedures connected with registration or conducting the investigations connected with quality of medicines).
7. Conducting inspection with use of means of remote interaction (for example, with use of means of audio-or video conference) is allowed in particular cases according to appendix No. 2.
8. For the organization of inspection by the applicant on conducting pharmaceutical inspection (further - the applicant) representation in pharmaceutical inspectorate in Russian and (or) (in the presence of relevant requirements in the legislation of state member) in state language of state member (or in transfer into these languages) the following documents shall be provided:
for the manufacturing organization (resident) who is in the territory of state member:
statement for conducting inspection;
the copy of the file (master file) of the production site according to part III of Rules of proper production practice containing the copy of license for activities on production of medicines (in the presence);
the list of the medicines made (planned to production) on the production site according to appendix No. 3;
for the manufacturing organization (nonresident):
statement for conducting inspection;
the copy of the file (master file) of the production site according to part III of rules of proper production practice;
the copy certified in accordance with the established procedure, or the electronic copy of the operating permission (license) for production of medicines issued by authorized body of the third country in the territory of which the production site or the statement from the corresponding register of the third country in the territory of which there is inspected subject is located;
the copy of the document issued by authorized body (organization) of the country in the territory of which medicines, about compliance of production (production site) to requirements of the rules of proper production practice applied in the country of origin (in the presence) or the electronic copy or the statement from the corresponding register of the country in the territory of which there is inspected object are made certified in accordance with the established procedure;
the list of the medicines made (planned to production) on the production site.
In conducting inspection it can be refused the following cases:
the data containing in the statement for conducting inspection (or) documents provided at the request of authorized body (organization) are incomplete and (or) doubtful;
the applicant does not provide conditions of conducting inspection that makes impossible holding procedure of inspection;
expenses on conducting inspection are not paid at the scheduled time (when applicable).
9. Inspection is carried out by pharmaceutical inspectorate of state member in the territory of which there is production site.
In case of inspection of the production site which is in the territory of the third countries, the applicant has the right to file in pharmaceutical inspectorate of one of state members petition for conducting inspection.
In case of documentary drawn up refusal of pharmaceutical inspectorate of state member of conducting inspection of the production site which is in the territory of the third country, the applicant has the right to address to authorized body (organization) of other state member with the statement for conducting inspection.
The inspection initiated within the registration procedures is carried out by pharmaceutical inspectorate of the state member determined according to the Rules of registration and examination of medicines for medical application approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 78.
10. The procedure of inspection consists of the following stages:
acceptance and examination of the submitted documents;
approval of the inspected subject or his authorized representative of terms of inspection;
forming of inspection team;
creation and the direction to the inspected subject or his authorized representative of the program of inspection;
inspection of the production site, including sampling (samples) of materials or products (if necessary) and conducting their laboratory researches;
creation of the report on conducting inspection (further - the report);
assessment (if necessary) the plan of the adjusting and warning actions, the report on its accomplishment and certificates of elimination of the revealed discrepancies;
decision making about issue or about refusal in issue of the certificate of conformity of the producer to requirements of Rules of proper production practice (further - the certificate);
issue of the certificate.
Terms of carrying out separate stages of inspection are established according to the legislation of state members taking into account these rules.
11. The inspection team is created based on the corresponding order of the head of pharmaceutical inspectorate according to the procedures established by the quality system of pharmaceutical inspectorate.
The number of inspection team constitutes at least two pharmaceutical inspectors.
12. The leading inspector and other members of inspection team shall study previously documents, including the file of the production site, and other available information relating to the inspection purposes, for example, the data on claims, defects of quality and withdrawals of products (in case of their availability) received from the state registers and databases or from other authorized bodies (organizations).
The leading inspector provides development of the program of inspection in form according to appendix No. 1 to these rules and preparation of check sheets in form according to appendix No. 4 or other forms of the working records provided by the quality system of pharmaceutical inspectorate. The program of inspection goes to the inspected subject not later than 10 working days before start date of inspection.
The leading inspector distributes functions in inspection team and coordinates the preparatory activities connected with inspection.
13. At the beginning of inspection the introductory meeting with representatives of the inspected subject on which the leading inspector represents members of inspection team is held, gets acquainted with management and responsible persons of the inspected subject, informs on the purpose and area of inspection, specifies the program of inspection and the schedule of its carrying out, makes the privacy policy statement and answers questions of the inspected party.
The inspected subject determines person responsible for assistance in conducting inspection.
14. Information obtained by inspection team during the course of performance of the program of inspection is introduced in check sheets or in other forms of working records.
15. Shall be reflected in the agreement (agreement) signed by pharmaceutical inspectorate and the inspected subject on conducting inspection including the following rights of the inspector:
get access (to enter) any room according to the program of inspection and to the file (master file) of the production site;
obtain such evidence as documentation, photographic materials (videos) of rooms and the equipment;
get access to any object (subject) within area of inspection and study it;
take measures or require taking measures concerning objects (material certificates) which presumably can testify to discrepancy to requirements of rules of proper production practice, including concerning restriction of access to such objects and ensuring their safety for the purpose of further trial in accordance with the established procedure;
perform survey of the checked objects, acquaintance with documentation and records, poll of responsible persons of the inspected subject, observation of activities on workplaces;
stop conducting inspection when preventing in realization of the specified rights.
The inspected subject also shall within the signed agreement (agreement) to undertake obligations to provide possibility of accomplishment of the actions provided by the program of inspection.
16. In case of identification of risk of life and to health of the population (including potential critical discrepancies) the leading inspector without delay informs the head of pharmaceutical inspectorate (by phone, e-mail or with use of other means of communication within 24 hours from the moment of detection of discrepancy), the head of the inspected subject and if necessary takes actions provided by the quality system of pharmaceutical inspectorate of state member according to Item 28 of these rules.
17. In case of need during inspection sampling (samples) of materials or products which go the inspected subject for testing to the test laboratory determined according to the legislation of state member, having competences according to the legislation of state members is performed. At the same time the cost of models of compensation is not subject.
The expenses connected with transportation, making of customs transactions and carrying out customs control concerning tests (samples) of materials and products moved through customs border of the Union, and also carrying out testing of tests (samples) the inspected subject bears. Import to customs area of the Union of the selected tests (samples) of materials and products is performed according to the international treaties and acts entering the right of the Union, regulating customs legal relationship and the legislation of state members on customs regulation.
18. The leading inspector upon completion of every day of inspection holds meeting with members of inspection team for discussion of preliminary observations which if necessary are discussed also with responsible persons of the inspected subject. In case of disagreements members of inspection team shall answer questions of representatives of the inspected subject. In case of detection of discrepancies which are planned to be classified as critical the leading inspector without delay informs on it responsible persons of the inspected subject.
Information on elimination provided by responsible persons of the inspected subject during conducting inspection of the revealed discrepancies is taken by inspection team into consideration and is subject to specifying in the report as discrepancies marked about their elimination during conducting inspection.
At final meeting with responsible persons of the inspected subject preliminary results by results of inspection with discussion of the revealed discrepancies for the subsequent preparation by the inspected subject of the plan of the adjusting and warning actions are disclosed (in case of need).
19. The leading inspector provides creation of the report on form according to appendix No. 5.
If during inspection discrepancies were not revealed, in columns 5 - the 7th tables of the Section 7 of part II of the report it is specified "is not applicable", the report in duplicate is constituted and signed by the leading inspector and members of inspection team no later than 30 calendar days from the date of inspection completion in time.
If only other discrepancies were revealed, in columns 5 - the 7th tables of the Section 7 of part II of the report it is specified "under the following inspectorate", the report in duplicate is constituted and signed by the leading inspector and members of inspection team no later than 30 calendar days from the date of inspection completion in time.
If during inspection critical and (or) essential discrepancies were revealed, it is constituted:
part I of the report in duplicate is also signed by the leading inspector and members of inspection team in time no later than 30 calendar days from the date of inspection completion;
part II of the report in duplicate is also signed by the leading inspector and members of inspection team in time no later than 30 calendar days from the date of representation by the inspected subject of the plan of the adjusting and warning actions and the report on its accomplishment (further - the answer) and documentary evidences of elimination of all discrepancies according to Item 23 of these rules or for the 61st calendar day from the date of receipt by the inspected subject of part I of the report in case of non-presentation by the inspected subject of the plan of the adjusting and warning actions, the report on its accomplishment and the data testimonial of elimination of the revealed discrepancies in time, stipulated in Item 23 these rules.
In case of sampling (samples) of materials or products the term of creation of the report is estimated from the date of receipt by the leading inspector of results of their testing.
One copy of the report (part I or part II) goes to the inspected subject (with the cover letter) no later than 3 working days from the date of its signing, the second copy is stored in archive of pharmaceutical inspectorate.
The pharmaceutical inspectorate represents the copy of the report to authorized body in the place of the arrangement.
Responsibility for reliability of the results of inspection stated in the report is assigned to pharmaceutical inspectors.
20. If during inspection other discrepancies were revealed, when conducting the following inspection the inspection team performs including:
assessment of the plan of the adjusting and warning actions;
assessment of the report on its accomplishment.
21. Production of medicines is recognized to relevant requirements of Rules of proper production practice one of the following cases:
lack of discrepancies;
lack of critical and essential discrepancies;
elimination of all critical and essential discrepancies by results of answer assessment.
22. Production of medicines is recognized non-compliant to the requirements of Rules of proper production practice one of the following cases:
if in the report on results of inspection critical and (or) essential discrepancies are established;
in case of not elimination of all critical and essential discrepancies by results of answer assessment;
in case of non-presentation of the answer in time, stipulated in Item 23 these rules;
in case of preventing in implementation by the inspector of the rights, stipulated in Item 15 these rules.
23. If when conducting inspection critical and (or) essential discrepancies were established, the inspected subject no later than 60 calendar days from the date of receipt of part I of the report sends to pharmaceutical inspectorate the answer with appendix of the plan of the adjusting and warning actions, the report on its accomplishment and the data testimonial of elimination of the revealed discrepancies.
24. The inspection team performs assessment containing in the answer of information and preparation of part II of the report according to the procedure established by the Section IV of these rules.
25. The authorized body (organization) of state member provides issue, modification, suspension, renewal, cancellation of the certificate by results of inspection.
According to the application submitted by the applicant with application of documents (their copies) which are confirming need of modification, not requiring conducting inspection (change of the name of the legal entity of the producer or the name of the production site, form of business of the legal entity of the producer, the address of the production site without change of its actual location, correction of typographical errors), in time no more than 20 working days from the date of submission of the specified statement changes can be made to the certificate with preserving its number, date (period) of inspection and effective periods with introduction of up-to-date information in databases of authorized bodies (organizations) of state members and the integrated information system of the Union.
26. In case of recognition of production of medicines to relevant requirements of rules of proper production practice, the authorized body (organization) issues the certificate in form according to appendix No. 6 (on the form of authorized body (organization) of state member) no later than 10 working days from the date of decision making about issue of the certificate according to the legislation of state member.
The certificate reflects the status of the production site for conducting inspection, extends to the dosage forms and production operations (productive activity) specified in it and is the document testimonial of the status of compliance. Effective period of the certificate cannot exceed 3 years from the date of inspection completion. Effective period of the certificate can be reduced when using the corresponding principles of risk management according to the quality system of pharmaceutical inspectorate, in the presence of the corresponding record about it in the certificate.
27. The basis for refusal in issue of the certificate is recognition of production of medicines non-compliant to the requirements of Rules of proper production practice.
In case of refusal in issue of the certificate the authorized body (organization) notifies the inspected subject according to the procedure, established by the legislation of state member, and in time no later than 10 working days from decision date about refusal in issue of the certificate.
28. In case of identification when conducting inspection of critical discrepancies to requirements of Rules of proper production practice the pharmaceutical inspectorate sends to authorized body (organization) of state member the written notice of the revealed discrepancies. The authorized body (organization) of state member can make the decision on suspension or cancellation of earlier issued certificate what no later than 5 working days from the date of inspection completion in writing notifies the inspected subject on, and also authorized bodies (organizations) of other state members and Eurasian economic commission.
29. The decision on renewal of action of earlier suspended certificate is made:
following the results of consideration of the plan of the adjusting and warning actions, the report on its accomplishment and certificates of elimination of the revealed discrepancies according to the procedure provided by Items 23 and 24 of these rules;
when obtaining from authorized body (organization) of other state member of information following the results of consideration of the plan of the adjusting and warning actions, the report on its accomplishment and certificates of elimination of the revealed discrepancies.
30. The authorized body (organization) of state member makes the decision on cancellation of earlier issued certificate in case:
refusal of the inspected subject of passing of inspection upon the demand of authorized body (organization);
failure to provide the inspected subject of conducting inspection upon the demand of authorized body (organization);
refusal in issue of the certificate by authorized body (organization) of state member the pharmaceutical inspectorate of which carried out inspection or authorized body (organization) of other state member.
31. If the inspected subject appeals results of inspection, consideration of claims (appeals) pharmaceutical inspectorate is performed according to the procedure and the terms established by the quality system of pharmaceutical inspectorate and the legislation of state members.
Submission of claims (appeals) to solutions of pharmaceutical inspectorate is performed according to the procedure, established by the legislation of state members.
32. Data on the issued certificates and certificates which it is suspended, renewed or stopped of data on modification of certificates are placed in databases of authorized bodies (organizations) of state members and the integrated information system of the Union.
33. Conducting pharmaceutical inspections with use of means of remote interaction is performed according to the procedure according to appendix No. 7.
to Rules of conducting pharmaceutical inspections
See Appendix No. 1 (45Kb In original language)
to Rules of conducting pharmaceutical inspections
Cases of conducting inspection with use of means of remote interaction (for example, by means of audio-or video conference)
1. Conducting inspection with use of means of remote interaction (for example, by means of audio-or video conference) according to acts of bodies of the Eurasian Economic Union in the following cases is allowed according to the solution of pharmaceutical inspectorate:
a) origin threat, origin and liquidation of emergency situation and (or) emergence of threat:
spread of the epidemic diseases constituting danger to people around;
the diseases and defeats received as a result of impact of adverse chemical, biological, radiation factors;
b) emergence of force majeure circumstances or the parties of circumstances, independent of will, which pose threat of damnification of life and to health of inspectors (for example, for political, medical or other reasons).
2. Before the inspection which is carried out with use of means of remote interaction, the manufacturing organization shall confirm these geolocations (width, longitude) of arrangement of the production site.
to Rules of conducting pharmaceutical inspections
See Appendix No. 3 (54Kb In original language)
to Rules of conducting pharmaceutical inspections
(form)
Check sheet
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Items of Rules of proper production practice of the Eurasian Economic Union |
Control question |
Identification of object |
Information (certificates) on compliance |
Information (certificates) on discrepancy |
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1 |
2 |
3 |
4 |
5 |
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to Rules of conducting pharmaceutical inspections
See Appendix No. 5 (57Kb In original language)
to Rules of conducting pharmaceutical inspections
See Appendix No. 6 (55Kb In original language)
to Rules of conducting pharmaceutical inspections
Procedure for conducting pharmaceutical inspection with use of means of remote interaction
I. General provisions
1. The pharmaceutical inspection of production of medicines providing inspection with use of means of remote interaction (further respectively - inspection, remote inspection), is carried out according to the Rules of conducting pharmaceutical inspections approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 83 (further - Rules), taking into account the features provided by this Procedure.
2. Conducting remote inspection is performed by pharmaceutical inspectors of authorized bodies (organizations) of state members of the Eurasian Economic Union by means of studying of documents, materials, holding interviews with representatives (employees) of the inspected subject with use of means of remote interaction (for example, by means of audio-or video conference), access to systems of exchange of information without departure of pharmaceutical inspectors on the production site.
II. Planning of inspection
3. In addition to provisions of Rules before conducting remote inspection the inspected subject submits documents and data according to the list according to appendix.
4. The pharmaceutical inspectorate makes the decision on conducting remote inspection on the basis of assessment of criteria of the risks provided by the quality system of this pharmaceutical inspectorate.
5. The documents and data specified in the list provided by appendix to this Procedure are represented by the applicant in case of acceptance by pharmaceutical inspectorate of the decision on conducting remote inspection.
Submission of the specified documents and data is not required if the applicant provides the letter on availability as a part of the file of the production site (the master file of the production site) of such documents (data) and they are urgent at the time of filing of application about conducting inspection.
III. Ensuring remote interaction with means
6. The pharmaceutical inspectorate is notified by the inspected subject on conducting remote inspection and on need of the organization of technical testing audio-and (or) video conference prior to inspection.
7. Ensuring remote interaction with use of technical means, and also their safety is performed by the inspected subject in coordination with pharmaceutical inspectorate.
8. In case of the unexpected situations connected with ensuring remote interaction with technical means during conducting remote inspection of the party without delay inform each other and take all feasible measures for elimination of technical malfunctions in perhaps short time.
9. By the quality system of pharmaceutical inspectorate rules of interaction of pharmaceutical inspectors in case of conducting remote inspection with use of different devices, and also methods of providing all members of inspection team with necessary documents and data shall be determined.
10. For the purpose of assessment of readiness of the inspected subject it is necessary to consider:
a) possibility of use of communication platforms for timely submission of information, especially for file transfer of large volume;
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