of November 3, 2016 No. 82
About approval of General requirements to the quality system of pharmaceutical inspectorates of state members of the Eurasian Economic Union
Astana
According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, article 10 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, Item 95 of appendix 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, and the Decision of the Supreme Eurasian economic council of December 23, 2014 "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 No. 108:
1. Approve the enclosed General requirements to the quality system of pharmaceutical inspectorates of state members of the Eurasian Economic Union.
2. To provide to authorized bodies (authorized organizations) of state members of the Eurasian Economic Union reduction of quality systems of pharmaceutical inspectorates of state members of the Eurasian Economic Union in compliance with the General requirements approved by this Decision till July 1, 2016 and to inform on it the Eurasian economic commission.
3. 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. 82
1. These General requirements establish single approach to development and deployment of the quality system in activities of pharmaceutical inspectorates of state members of the Eurasian Economic Union (further respectively – state members, the Union) in case of accomplishment of pharmaceutical inspections.
These General requirements determine policy in the field of quality of pharmaceutical inspectorates, and also procedures and procedure for planning, the organization and conducting pharmaceutical inspections.
2. For the purposes of these General requirements concepts which mean the following are used:
"policy in the field of quality of pharmaceutical inspectorate" – assistance to protection of health of the population by means of conducting pharmaceutical inspections of subjects of drug circulation, and also by means of effective and rational activities of pharmaceutical inspectorates according to the acts entering the right of the Union in the field of drug circulation and the legislation of state members, implementations of the quality system of pharmaceutical inspectorates according to the quality manual of pharmaceutical inspectorate;
"the quality system of pharmaceutical inspectorate" – complex provided in the quality manual and in the procedures of pharmaceutical inspectorate of elements adopted in the form of the written instrument (such as organizational structure, responsibility, procedures, systems, processes and resources), and also the established measures necessary for goal achievement of pharmaceutical inspectorate in the field of quality and the established quality regulations;
"pharmaceutical inspection" – assessment of subjects of drug circulation, including the organizations of health care, for the purpose of establishment of compliance of pharmaceutical production and other activities for drug circulation to the acts entering the right of the Union;
"the pharmaceutical inspector" – the face authorized on conducting pharmaceutical inspection and included in the register of pharmaceutical inspectors of the Union;
"pharmaceutical inspectorate" – the structural division of authorized body (authorized organization) in the field of drug circulation of state member which is carrying out pharmaceutical inspections.
3. Pharmaceutical inspections are carried out by pharmaceutical inspectorates according to the acts entering the right of the Union in the field of drug circulation, and also the legislation of state members in the field.
4. Main objective of functioning of the quality system of pharmaceutical inspectorates is ensuring uniformity, high level of conducting pharmaceutical inspections and mutual recognition of results of pharmaceutical inspections.
5. These General requirements are held for use pharmaceutical inspectorates as basis for development of own quality system of pharmaceutical inspectorate.
6. These General requirements are developed taking into account recommendations of System of cooperation about pharmaceutical inspections (PIC/S) of PI 002-3 "Recommendation on Quality System Requirements for Pharmaceutical Inspectorates" and the state standard specification ISO 19011-2013 standard "Guidelines on audit of systems of management".
7. The pharmaceutical inspectorate shall develop and approve the quality manual according to these General requirements. The quality manual of pharmaceutical inspectorate shall cover all aspects of activities of pharmaceutical inspectorate and include the procedures of the quality system of pharmaceutical inspectorate and (or) the reference to them adopted in the form of the written instrument.
8. The quality manual of pharmaceutical inspectorate affirms the head of pharmaceutical inspectorate.
9. The quality manual of pharmaceutical inspectorate establishes requirements and procedures of the quality system of pharmaceutical inspectorate for personnel of pharmaceutical inspectorate and the involved experts and is used for:
a) confirmations of availability at personnel of pharmaceutical inspectorate sufficient qualifications, knowledge and experience allowing to fulfill the requirements established by the acts entering the right of the Union and the legislation of state members;
b) determinations of conditions in case of which there is need for carrying out internal and external audits of the quality system of pharmaceutical inspectorate.
10. The quality manual of pharmaceutical inspectorate is submitted on demand to authorized bodies (authorized organizations) of state members, and also according to the decision of the head of pharmaceutical inspectorate – other interested persons for confirmation of availability of the quality system of pharmaceutical inspectorate existing in pharmaceutical inspectorate.
11. The organizational structure of pharmaceutical inspectorate shall correspond to objectives and guarantee ensuring impartiality of pharmaceutical inspectors when conducting pharmaceutical inspections.
The rights and obligations of the head and personnel of pharmaceutical inspectorate are determined by job descriptions.
12. Actions of pharmaceutical inspectors, including the decisions made by them, shall not depend on commercial, financial or other interests.
The pharmaceutical inspectorate shall provide lack of influence of any persons on results of inspection.
Compensation of pharmaceutical inspectors shall not depend on results of pharmaceutical inspections, including in case of decision making about the termination (suspension) of action of certificates of conformity of producers of medicines to requirements of the rules of proper production practice of the Union approved by the Eurasian economic commission and permissions (licenses) concerning subjects of drug circulation.
Pharmaceutical inspectors document refusal of implementation any other (in addition to conducting pharmaceutical inspections) activities for remuneration which can influence their judgment and freedom of action when implementing official functions.
Pharmaceutical inspectors shall inform the head of pharmaceutical inspectorate on any attempts to exert impact on independence of their judgments and actions immediately.
13. By the quality system of pharmaceutical inspectorate the order of interaction of pharmaceutical inspectorate with other divisions of authorized body (authorized organization) of state member and other organizations (including with accredited laboratories on quality control of medicines) and the executive bodies of state member performing licensing of production of medicines, and also control (supervision) in the field of drug circulation shall be established.
14. In the quality system of pharmaceutical inspectorate the standard operational procedure for interaction of pharmaceutical inspectorate of one state member with pharmaceutical inspectorates of other state members on exchange of information and the organization of joint pharmaceutical inspections according to the acts entering the right of the Union shall be adopted in the form of the written instrument and the list of persons responsible for the specified interaction is determined.
15. The pharmaceutical inspectorate does not provide consulting services to individuals or the organizations which are subject to inspection. Participation of personnel of pharmaceutical inspectorate in open seminars, conferences and meetings, performance with reports, and also publications in specialized printing editions is allowed.
16. The quality system of pharmaceutical inspectorate is installed for:
a) planning of conducting pharmaceutical inspections with indication of their duration and frequency according to analysis results of risks and according to the acts entering the right of the Union in the field of drug circulation, and also the legislation of state members in the field of control and supervising activities;
b) conducting pharmaceutical inspections according to the acts entering the right of the Union and the legislation of state members in the field of drug circulation, and also documents of the quality system of pharmaceutical inspectorate;
c) ensuring accuracy and objectivity of observations, results of pharmaceutical inspections, and also the subsequent actions specified in reports on inspection of recommendations and planned;
d) performance guarantees of pharmaceutical inspections according to the acts entering the right of the Union, the legislation of state members and procedures of pharmaceutical inspectorate adopted in the form of the written instrument.
17. The pharmaceutical inspectorate shall develop and approve regulations on pharmaceutical inspectorate and the scheme of organizational structure in which are reflected subordination to authorized body (authorized organization) of state member and interaction with structural divisions of authorized body (authorized organization) of state member.
18. The head of pharmaceutical inspectorate and its deputies treat the top management of pharmaceutical inspectorate.
19. The quality system of pharmaceutical inspectorate provides responsibility of the head of pharmaceutical inspectorate for:
a) determination of policy in the field of quality of pharmaceutical inspectorate;
b) distribution of obligations and powers between personnel of pharmaceutical inspectorate;
c) allocation of the resources necessary for realization of policy in the field of quality of pharmaceutical inspectorate.
20. The head of pharmaceutical inspectorate performs the analysis of the report on functioning of the quality system of pharmaceutical inspectorate.
21. Division managers of pharmaceutical inspectorate bear responsibility for:
a) creation of plans of conducting pharmaceutical inspections and ensuring their accomplishment;
b) ensuring activities of pharmaceutical inspectors according to the procedures of the quality system of pharmaceutical inspectorate adopted in the form of the written instrument;
c) exact execution by pharmaceutical inspectors of the procedures of pharmaceutical inspectorate adopted in the form of the written instrument;
d) acceptance of adequate measures in case of identification of shortcomings of work of divisions of pharmaceutical inspectorate;
e) creation of the annual report on functioning of the quality system in divisions of pharmaceutical inspectorate regarding the competence.
22. The personnel of pharmaceutical inspectorate bear responsibility for accomplishment of the job responsibilities, observance of requirements of the quality manual of pharmaceutical inspectorate and the procedures of pharmaceutical inspectorate adopted in the form of the written instrument.
23. The head of pharmaceutical inspectorate designates person responsible for maintenance of the quality system of pharmaceutical inspectorate.
Person responsible for maintenance of the quality system of pharmaceutical inspectorate is the representative of the top management of pharmaceutical inspectorate, is under direct supervision at the head of pharmaceutical inspectorate and shall have direct access to the head of pharmaceutical inspectorate concerning functioning of the quality system of pharmaceutical inspectorate.
24. The report on functioning of the quality system of pharmaceutical inspectorate is constituted for last year.
25. The report on functioning of the quality system of pharmaceutical inspectorate includes the following data:
a) the carried-out pharmaceutical inspections, including amount of the revealed discrepancies of the inspected subjects of drug circulation on primary groups of classification (critical, essential, other);
b) the number of pharmaceutical inspections in which each pharmaceutical inspector (including the involved experts), and also amount of the discrepancies revealed by each of them participated;
c) the number of the joint pharmaceutical inspections which are carried out with pharmaceutical inspectorates of other state members (including results of pharmaceutical inspections);
d) the certificates withdrawn at subjects of drug circulation, permissions (license);
e) data on claims, appeals and addresses (including internal);
e) cases and attempts of external pressure upon personnel of pharmaceutical inspectorate (including the involved experts);
g) results of internal and external audits;
h) actions taken adjusting and warning (corrective action and preventive action, CAPA) pharmaceutical inspectorate (including accomplishment of actions for results of the previous analysis from management);
i) changes in the quality system of pharmaceutical inspectorate;
j) training (including the involved experts).
26. The data specified in Item 25 of these General requirements shall be provided in comparison with data for previous years in the evident form allowing to estimate tendencies of changes.
The report on functioning of the quality system of pharmaceutical inspectorate shall come to an end with comparison of results of functioning of the quality system of pharmaceutical inspectorate for last year with the effective objectives and indicators of quality specified in subsection 1 of the Section IX of these General requirements.
On analysis results of the report on functioning of the quality system of pharmaceutical inspectorate assessment of goal achievement and indicators of quality, the adjusting and warning actions (CAPA) or changes in the quality system of pharmaceutical inspectorate certified by signatures of the top management of pharmaceutical inspectorate is brought in the report.
27. On the basis of the submitted report the top management carries out the analysis of functioning of the quality system of pharmaceutical inspectorate, takes out estimates of its efficiency and realization of policy in the field of quality of pharmaceutical inspectorate. By results of this analysis quality indicators are staticized, the adjusting and warning actions (CAPA) or actions for improvement of the quality system of pharmaceutical inspectorate, including enhancement of policy in the field of quality of pharmaceutical inspectorate are determined.
28. The report on functioning of the quality system of pharmaceutical inspectorate with analysis results of functioning of the quality system of pharmaceutical inspectorate is stored in pharmaceutical inspectorate within 5 years.
29. The pharmaceutical inspectorate develops and supports management system documentation of the quality system of pharmaceutical inspectorate. Documentation of the quality system of pharmaceutical inspectorate includes:
a) the policy of pharmaceutical inspectorate accepted in the form of the separate written instrument in the field of quality;
b) quality manual of pharmaceutical inspectorate;
c) the standard operational procedures adopted in the form of the written instrument;
d) texts of the acts entering the right of the Union, and acts of the legislation of state members in the field of drug circulation which determine activities of pharmaceutical inspectorate and influence its quality.
30. The management system shall provide with documentation of the quality system of pharmaceutical inspectorate that the documents specified in Item 29 of these General requirements were approved by the corresponding faces, and the personnel of pharmaceutical inspectorate performed activities according to current versions of documents.
In pharmaceutical inspectorate the protocol of distribution of all documents necessary for activities of pharmaceutical inspectorate and functioning of its quality system shall be taken. The management system shall provide with documentation of the quality system of pharmaceutical inspectorate withdrawal of old document revisions from document flow and their storage during fixed term.
31. The management system shall provide with documentation of the quality system of pharmaceutical inspectorate control of all changes and their corresponding approval. Measures of identification (identification) of changes in separate documents shall be developed.
Control of organizational and administrative documentation is exercised according to the procedure for clerical work and document flow established in pharmaceutical inspectorate.
32. The pharmaceutical inspectorate installs and supports system of the records representing special document type (further – records), and the reporting, corresponding to the acts entering the right of the Union and also the legislation of state members.
33. Join the detailed information about planning of conducting pharmaceutical inspections, their carrying out in records, process description of conducting pharmaceutical inspections.
Reports on pharmaceutical inspections join observations, results, recommendations and information on the subsequent actions.
34. Treat obligatory records and reports of pharmaceutical inspectorate:
a) plans of pharmaceutical inspections;
b) requests for pharmaceutical inspections, including appendices;
c) programs of pharmaceutical inspections;
d) working records of pharmaceutical inspectors;
e) reports on conducting pharmaceutical inspections;
e) reports on carrying out internal audits;
g) plans and reports on accomplishment of the adjusting and warning actions (CAPA) of pharmaceutical inspectorate;
h) report on functioning of the quality system;
i) documents on personnel training (personal files);
j) personal records (personal files) of the involved experts.
35. During the work with records and reports the conditions preventing their spoil or loss shall be provided.
Records and reports shall be stored during fixed term. All records and reports of pharmaceutical inspectorate are not public. Representation of records and reports to pharmaceutical inspectorates of other state members in the presence of the relevant agreements between pharmaceutical inspectorates is allowed.
36. In the quality system of pharmaceutical inspectorate only originals of documents and (or) their verified copies are subject to management of documentation. All documents shall be identified with indication of type, the name, date and the signatures of the contractor approving and approving persons.
37. The pharmaceutical inspectorate carries out pharmaceutical inspections of subjects of drug circulation with report layout about conducting pharmaceutical inspections in the established form.
38. The pharmaceutical inspectorate shall develop and adopt procedures for conducting pharmaceutical inspections in the form of written instruments.
39. If 2 pharmaceutical inspectors and more participate in pharmaceutical inspection, the head of pharmaceutical inspectorate appoints the leading inspector for coordination of activities of inspection team.
When conducting joint pharmaceutical inspections the leading pharmaceutical inspector is appointed from pharmaceutical inspectorate of the state member initiating conducting pharmaceutical inspection.
40. The leading pharmaceutical inspector prepares the inspection report and approves it with other pharmaceutical inspectors of inspection team. The inspection report which is drawn up in accordance with the established procedure shall go to the authorized person of the inspected subject of drug circulation.
41. The leading pharmaceutical inspector and other pharmaceutical inspectors of inspection team shall participate in assessment of the answer of the inspected subject of drug circulation by results of pharmaceutical inspection to determine sufficiency of corrective actions and degree of compliance of the inspected subject of drug circulation to the acts entering the right of the Union in the field of drug circulation and to the legislation of state members in the field of drug circulation.
42. The observations and (or) data received during pharmaceutical inspection shall be fixed timely on paper or electronic media of information for prevention of loss of data.
Results of conducting pharmaceutical inspections shall be analyzed for assessment of their compliance to the quality system of pharmaceutical inspectorate.
43. The pharmaceutical inspectorate shall have the resources necessary for realization of policy in the field of quality of pharmaceutical inspectorate.
44. The pharmaceutical inspectorate is completed with necessary personnel for the organization and conducting pharmaceutical inspections of activities of subjects of drug circulation on compliance to the acts entering the right of the Union in the field of drug circulation according to the staff list.
The personnel of pharmaceutical inspectorate shall undergo the corresponding continuous training to have opportunity to carry out the obligations.
45. Requirements to education, qualification, work experience, and also tasks and functions of personnel are established in the job descriptions approved by the head of pharmaceutical inspectorate.
46. Pharmaceutical inspectors shall:
a) know the acts entering the right of the Union, regulating drug circulation, and also documents of the quality system of pharmaceutical inspectorate;
b) have the corresponding preparation, nobility and apply methods of conducting pharmaceutical inspections;
c) take out the professional conclusions about compliance of the inspected subject of drug circulation to the acts entering the right of the Union in the field of drug circulation and be able to apply risk evaluation methods;
d) have other knowledge necessary for conducting pharmaceutical inspections, including knowledge in the field of the computerized systems and information technologies.
47. The pharmaceutical inspectors employed (involved to conducting pharmaceutical inspection), participate as trainees in at least, than five inspections. The admission of pharmaceutical inspectors to independent activities is performed after check of their knowledge by the head of pharmaceutical inspectorate according to the procedure, established by documents of the quality system of pharmaceutical inspectorate.
Further training (training) of the specified pharmaceutical inspectors shall constitute at least 10 days (at least 60 class periods) of participation in the training actions a year. The head of pharmaceutical inspectorate on regular basis carries out the analysis of professional training of each pharmaceutical inspector and determines the needs for its further preparation (training).
48. Training of pharmaceutical inspectors and its results shall be documented properly.
Records about trained and the received qualification are stored in the document on training (the personal file) of each pharmaceutical inspector.
49. The document on training (the personal file) of each pharmaceutical inspector includes the following personal data:
a) education and specialty according to the diploma;
b) qualification;
c) work experience;
d) obligations and responsibility;
e) specialization within pharmaceutical inspectorate;
e) data on preparation (training), advanced training and the final estimates received during preparation (training), advanced training.
50. The personal file of the involved expert join data on post and qualification, and also information on its participation in pharmaceutical inspections.
51. The pharmaceutical inspectorate shall have the equipment necessary for ensuring its activities, including rooms, furniture, computer and office equipment, means of communication, information resources and transport.
52. The pharmaceutical inspectorate performs and documents annual internal audit of the activities for assessment of its compliance to requirements of the quality system of pharmaceutical inspectorate.
All elements of the quality system of pharmaceutical inspectorate are subject to audit. Criteria of audit are requirements, quality systems of pharmaceutical inspectorate installed in documents.
53. Responsibility for carrying out internal audit is born by the head of pharmaceutical inspectorate. Audit is booked by personnel and the top management of pharmaceutical inspectorate in the form of cross check so that checking were not responsible for the checked activities.
54. By results of internal audit the report in which the revealed discrepancies and taken adjusting and preventing actions (CAPA) are reflected is constituted. Results of internal audits and the related adjusting and warning actions (CAPA) join in the report on functioning of the quality system of pharmaceutical inspectorate and are subject to the analysis from the top management.
55. Internal audits are booked according to requirements of the state standard specification ISO 19011-2013 standard "Guidelines on audit of systems of management".
56. Reports on internal audits shall be stored in pharmaceutical inspectorate within 5 years.
57. The main indicators of quality of activities of pharmaceutical inspectorate are established or staticized by person responsible for maintenance of the quality system of pharmaceutical inspectorate, based on policy in the field of quality on analysis results of the report on functioning of the quality system in year from the head of pharmaceutical inspectorate.
58. Indicators of quality of activities of pharmaceutical inspectorate include:
a) advanced training of pharmaceutical inspectors, receipt by pharmaceutical inspectors of the next qualification category, performance at seminars, conferences;
b) accomplishment of the plan of pharmaceutical inspections;
c) adherence to deadlines of conducting pharmaceutical inspections and submission of reports on conducting pharmaceutical inspections according to the acts entering the right of the Union in the field of drug circulation and documents of the quality system of pharmaceutical inspectorate;
d) the average number of days of participation in pharmaceutical inspections falling on one pharmaceutical inspector;
e) degree of uniformity of distribution of inspection loading between pharmaceutical inspectors;
e) quantity and categories of the pharmaceutical inspections and pharmaceutical inspections of violations (discrepancies) of the acts entering the right of the Union reflected in documents by results of carrying out revealed by each pharmaceutical inspector when carrying out in the field of drug circulation;
g) quantity of reasonable complaints about activities of pharmaceutical inspectorate, including internal, and timeliness of their consideration;
h) effectiveness of accomplishment of the adjusting and warning actions (CAPA) of pharmaceutical inspectorate.
59. The analysis of accomplishment of indicators of quality of activities of pharmaceutical inspectorate is considered as part of the analysis of the quality system of pharmaceutical inspectorate in general.
60. The decision on carrying out the adjusting and warning actions (CAPA) is accepted by the head of pharmaceutical inspectorate based on reports on internal and external audits, results of consideration of claims to activities of pharmaceutical inspectorate, the analysis of the quality system of pharmaceutical inspectorate and other records specifying availability of the discrepancies connected with activities of pharmaceutical inspectorate.
If in case of investigation of the discrepancy connected with activities of pharmaceutical inspectorate as the reason of discrepancy the mistake of the pharmaceutical inspector is supposed, it shall be documented with the purpose to certify detection of the existing process, procedural or system error or problem which entailed this discrepancy.
61. Based on analysis results of the quality system, protocols of meetings, other documents and records of the top management, and also in case of change of the acts entering the right of the Union in the field of drug circulation, legislations of state members and other mandatory requirements shall be drafted actions for improvement of the quality system of pharmaceutical inspectorate.
Actions for improvement of the quality system of pharmaceutical inspectorates belong to the adjusting and warning actions (CAPA) and are controlled within one quality system of pharmaceutical inspectorate.
62. The adjusting and warning actions (CAPA) and information on actions for improvement of the quality system of pharmaceutical inspectorate are brought in the magazine of control of accomplishment of the adjusting and warning actions (CAPA)-faced, responsible for maintenance of the quality system of pharmaceutical inspectorate, with indication of content of discrepancy, the reference to records about establishment of the adjusting and warning actions (CAPA), content of the adjusting and warning actions (CAPA), persons, actionees of the adjusting and warning actions (CAPA), terms, results of control of accomplishment, mark about accomplishment, references to the records containing accomplishment confirmation.
In case of creation of the report on functioning of the quality system of pharmaceutical inspectorate effectiveness of the adjusting and warning actions (CAPA) is estimated. The adjusting and warning actions (CAPA) are recognized productive in the absence of the repeated discrepancies caused by the same reason to which elimination the previous adjusting and warning actions (CAPA) were directed.
63. The pharmaceutical inspectorate shall develop and apply the instruction for work with the claims connected with its activities or performance of works by persons and the organizations working under the agreement. The instruction shall provide application and confirmation of the adjusting and warning actions (CAPA) taken as a result of consideration of claims.
64. Protocols of consideration of the received complaints and actions taken concerning these claims shall be stored during the term established in pharmaceutical inspectorate.
65. The quality system of pharmaceutical inspectorate shall provide order of interaction of pharmaceutical inspectorate with the laboratories accredited according to the procedure, established by the acts entering the right of the Union for exchange of information concerning quality control of medicines.
66. The pharmaceutical inspectorate has the right to involve the staff of accredited laboratories in sampling and testing of medicines when conducting pharmaceutical inspections.
67. The pharmaceutical inspectorate has the right to recruit in pharmaceutical inspections of independent experts.
The involved experts carry out certain obligations when conducting pharmaceutical inspection, but do not bear responsibility for accuracy and objectivity of results of pharmaceutical inspection.
The involved experts shall be informed of requirements of documents of the quality system of pharmaceutical inspectorate.
68. In case of the choice of experts it is necessary to take their independence of the inspected subject of drug circulation, and also possibility of conflict of interest of the involved expert and the inspected subject of drug circulation into account. The involved experts prior to conducting pharmaceutical inspection shall sign the document which contains the obligation (declaration) on independence of the inspector of the inspected subject of drug circulation within the last 2 years and about preserving confidentiality of documents and results of pharmaceutical inspection, and also about lack of financial interests and obligations to owners or management of the inspected organization.
69. The pharmaceutical inspectorate posts on the official site of authorized body (authorized organization) of state member on the Internet the following data:
a) list of procedures of inspection of subjects of drug circulation;
b) plan and terms of conducting pharmaceutical inspections;
c) procedure for decision making by results of pharmaceutical inspections;
d) order of interaction with the inspected subjects;
e) the carried-out pharmaceutical inspections with indication of their results and lists of holders of certificates based on the carried-out pharmaceutical inspections.
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