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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5577_Библиотеки_им_академика_М_И_Перельмана.pdf
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
Source: Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S)
11. Czech Republic State Institute for Drug Control
12. Czech Republic Institute for State Control of Veterinary
Biologicals and Medicines
13. Danish Medicines Agency
14. Estonia State Agency of Medicines
15. Finnish Medicines Agency
16. French National Agency for Medicines and Health Products
Safety
17. French Agency for Food, Environmental & Occupational
Health Safety
18. Germany Central Authority of the Laender for Health Protection regarding Medicinal Products and Medical Devices
19. Greek National Organization for Medicines
20. Pharmacy and Poisons Board of Hong Kong
21. Hungary National Institute of Pharmacy and Nutrition
22. Icelandic Medicines Agency
WHO Listed Authority and Other International Reliance and Harmonization Initiatives
23. Indonesian Food and Drug Authority
24. Iran Food and Drug Administration
25. Ireland Health Products Regulatory Authority
26. Israel Institute for Standardization and Control of
Pharmaceuticals
27. Italian Medicines Agency
28. Italy Directorate General for Animal Health and Veterinary
Medicinal Products
29. Japan Ministry of Health, Labor and Welfare/Pharmaceuticals
and Medical Devices Agency
30. Korea Ministry of Food and Drug Safety
31. Latvia State Agency of Medicines
32. Liechtenstein Oce of Healthcare
33. Lithuania State Medicines Control Agency
34. Malaysia National Pharmaceutical Regulatory Agency
35. Malta Medicines Authority
36. Mexico Federal Commission for the Protection Against Sanitary Risks
37. Netherlands Health and Youth Care Inspectorate
38. New Zealand Medicines and Medical Devices Safety
Authority
39. Norwegian Medicines Agency
40. Poland Chief Pharmaceutical Inspectorate
41. Portugal National Authority of Medicines and Health
Products, IP
42. Romania National Agency for Medicines and Medical Devices
of Romania
43. Saudi Food and Drug Authority
44. Singapore Health Sciences Authority
45. Slovak Republic State Institute for Drug Control
46. Slovenia Agency for Medicinal Products and Medical Devices
47. South African Health Products Regulatory Authority
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
48. Spanish Agency of Medicines and Medical Devices
49. Swedish Medical Products Agency
50. Swiss Agency for Therapeutic Products
51. Thailand Food and Drug Administration
52. Turkish Medicines and Medical Devices Agency
53. Ukraine State Service for Medications and Drugs Control
54. United Kingdom Medicines and Healthcare Products Regulatory Agency
55. United Kingdom Veterinary Medicines Directorate
56. United States Food and Drug Administration
4.5.10.3. Benefits of PIC/S Membership
The main benefits for the inspectorate include:
• Training opportunities for pharmaceutical inspectors
• International GMP harmonization
• Networking opportunities for pharmaceutical inspectors
• Assuring high standard of pharmaceutical inspections
• Sharing of pharmaceutical information
• Facilitating a Rapid Alert System
• Facilitating negotiation and conclusion of MRAs on GMP
inspection, e.g. Australia-Canada MRA, EU-Switzerland MRA,
Singapore-Australia MRA and ASEAN Sectoral MRA on GMP
Inspection.
Indirect benefits of PIC/S membership for industry include:
• Reduced duplication of GMP inspections amongst Participating
Authorities;
WHO Listed Authority and Other International Reliance and Harmonization Initiatives
• Cost savings to regulators and industry;
• Export facilitation; and
• Enhanced market access for medicinal products.
4.5.11. WHO Collaborative Registration Procedure for Medical Products (CRP)
In 2013, WHO launched a CRP for accelerated
approval of WHO-prequalified pharmaceutical
products. This WHO scheme is aimed at accelerating the registration of medical products
through improved information sharing between
WHO pre-qualification and NRAs. In many
countries with limited regulatory resources, registration of pharmaceutical products can take a considerable time. In the worst-case
scenarios, this time can extend to more than two or three years;
this means that patients may not receive treatment that could save
their lives or improve their state of health. Eective application of
CRP contributes to shorter time to national registration, optimization of limited pre-market registration resources, and product
traceability and transparency for buyers, given the verified sameness between the prequalified product and the product registered
at national level.
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This WHO CRP scheme has been further extended to pharmaceutical products that have already received approval from a SRA
besides WHO. In essence, the CRP is a procedure that allows NRAs
to leverage the work performed by SRAs through the use of the
concept of reliance. Reliance enables regulatory authorities to use
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
assessments performed by other regulatory authorities while maintaining national sovereignty, optimizing limited resources, avoiding duplication of work where possible and reducing the time for
access. Since the establishment of CRP till mid-2021, 88 product
applications have been submitted through the CRP, with 59 approvals granted to 16 medicinal products in 23 countries.
In 2021, WHO published two sets of guidelines namely Good Reliance
Practices (TRS 1033, Annex 10) and Good Regulatory Practices (TRS
1033, Annex 11). These guidelines provide recommendations to the
national medicines regulatory authorities to leverage the outputs of
other trusted regulatory authorities, whenever possible, while placing
greater focus at the national level on value-added regulatory activities.
4.5.12. WHO Prequalification Inspection for Medical Products
4.5.12.1. Introduction
WHO Prequalification aims to ensure key medical products meet
international standards of qua lity, safety and ecacy, in order to
optimize use of health resources and improve health outcomes. In
this regard, WHO Inspection Services supports and collaborates
internally with its product review team in the prequalification of
priority health products. These priority products include in vitro
diagnostics, medicines, vaccines, active pharmaceutical ingredients and vector control products. WHO Inspection Services conduct on-site and/or desk assessments of information submitted in a
dossier to evaluate compliance of manufacturers, contract research
WHO Listed Authority and Other International Reliance and Harmonization Initiatives
organizations and laboratories with good practices, international
standards and norms. In addition, WHO Inspection Services promotes collaboration and sharing of information with and among
NRAs and partner organizations in order to:
• maximize the use of inspection resources;
• leverage international inspection experience, expertise and
information;
• maximize the usefulness of the inspection outcome;
• minimize the regulatory burden on those inspected;
• minimize registration time; and
• improve access to priority health products.
4.5.12.2. WHO Prequalification Inspection Principles
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In general, the conduct of WHO Prequalification inspections is
guided by the following principles:
• Language medium for inspection
All inspections are conducted in English. To enable a smooth and
eective inspection, the relevant higher-level quality management
documents must be available in English. The need for any appropriate translator and interpreter shall be discussed with the site well
ahead of the inspection.
• Dates and time allocated for inspection
The dates and time scheduled for an inspection are to be agreed
upon by all participants under the guidance of the lead inspector and documented in an inspection plan. Time allocated to the
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
inspection will vary according to the scope of the inspection, the
complexity of the site and the products.
• Travel and accommodation arrangements
The WHO lead inspector is responsible for organizing the travel and
accommodation of the inspection team. If requested by WHO, the
manufacturer will use its local knowledge to assist with safe travel
and accommodation arrangements for the inspection team.
• Quality risk management
All inspections shall be planned, conducted and, in the case of routine inspections, scheduled at a frequency and level of detail taking
into account risk-based principles and considering the nature and
availability of the products and the compliance history and complexity of the respective site(s).
• Transparency and sharing of information
The outcome of an inspection shall be published on the WHO Inspection Services webpage as “WHO Public Inspection Report (WHOPIR)”
or, in case of non-compliance, as “Notice of Concern” (NOC). Upon
request, WHOPIRs may be shared with NRAs and partner organizations. Similarly, the experience of NRAs operating to equivalent
standards and stringency to those of WHO Prequalification inspections may be leveraged. Where satisfactory inspection evidence is
available, it shall be considered in the planning of on-site inspections
and inspections may be waived, deferred or otherwise modified.
• Resources and competence
Inspection resources shall be appropriate in terms of education,
auditing skills, experience in regulatory requirements, technical
WHO Listed Authority and Other International Reliance and Harmonization Initiatives
background and expertise, time allocation and access to external
scientific and other information, thereby contributing to the reliability of the inspection results.
• Independence and confidentiality
Members of the inspection team shall be impartial and free from
any conflict of interest or influence that could negatively aect their
objectivity. The inspectors shall maintain confidentiality regarding
information and documentation related to the inspection and shall
comply with the defined WHO standards of conduct.
• Consistency of procedures
The inspection shall be performed according to defined WHO guidelines and standard operating procedures, and be led by a WHO Prequalification inspector to ensure consistency during the inspection.
He has overall responsibility for the inspections, and shall ensure
consistency between inspections of the same type and scope.
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• Adequacy of inspection documentation
Documentation associated with each inspection, such as inspection
reports, shall provide adequate information related to the prequalification assessment of the product, for ensuring continuity between
successive inspections.
• Inspection results and conclusions
The results and conclusions of the inspections shall be consistent and accurate, subject to the normal limitations of an inspection, and considering the objective evidence collected during the
inspection.
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
4.5.12.3. WHO Inspection Report
A WHOPIR is a publicly available summary of the report of an
on-site inspection or of a desk assessment indicating that the site or
study is compliant with relevant WHO inspection guidelines, international standards and norms, and in adherence with the dossier
information. WHOPIR are published on the WHO Prequalification
webpage for transparency purposes. Each WHOPIR provides the
date and duration of the Prequalification inspection together with a
description of the scope, product(s), facilities and on-site operations,
and a summary of the inspection observations and findings. However, WHOPIRs exclude confidential proprietary information, and
they are posted on the WHO Prequalification webpage only with
the agreement of the manufacturer, CRO or laboratory. A WHOPIR
is posted only for a site that is deemed to be compliant with WHO
inspection guidelines, international standards and norms. The
WHO Inspection Services will publish a NOC if a site does not
meet international standards and norms, following the completion
of the inspection process. If a manufacturing site or laboratory has
been inspected several times, only the WHOPIR of the most recent
inspection is available on this webpage. Unless otherwise specified,
each WHOPIR remains on this page for three years, after which it is
moved to the Archived WHOPIRs section.
Many pharmaceutical manufacturers from around the world participate in WHO Prequalification inspections, in particular those
from China and India. The co-author (Sia Chong Hock) has participated in several, including two mega-facilities in China in October
2019, together with Mr. Vimal Sachdeva, a Lead WHO Prequalification inspector.
WHO Listed Authority and Other International Reliance and Harmonization Initiatives
WHO PQ inspection of API manufacturing facilities in China — 21–28 October
2019
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4.5.13. ZaZiBoNa
The ZaZiBoNa collaborative medicines registration initiative was
established in 2013 by four countries, namely, Zambia, Zimbabwe,
Botswana, and Namibia, with technical support from the WHO
Prequalification Team. The acronym ZaZiBoNa was derived from
the first two letters of the founding countries. Although this initiative has expanded beyond these four founding countries, the name
ZaZiBoNa has been maintained because of its special meaning in
Nyanja, one of the local Zambian languages. ZaZiBoNa means: