Introduction
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was established in 1995 as an extension to the Pharmaceutical Inspection Convention (PIC) of 1970.
PIC/S Committee meeting in Kiev (Ukraine), 2012
Welcome to the PIC/S website!
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any Authority having a comparable GMP inspection system. PIC/S presently comprises 56 Participating Authorities coming from all over the world (Europe, Africa, America, Asia and Australasia).
PIC/S aims at harmonising inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to Inspectors. It also aims at facilitating co-operation and networking between competent authorities, regional and international organisations, thus increasing mutual confidence. This is reflected in PIC/S’ mission which is to lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates in the field of medicinal products.
This is to be achieved by developing and promoting harmonised GMP standards and guidance documents; training competent authorities, in particular Inspectors; assessing (and reassessing) inspectorates and facilitating the co-operation and networking for competent authorities and international organisations.
The current website provides information on
— PIC/S in general (see “About”);
— Members (the “PIC/S Participating Authorities”);
— Publications (Guides, guidance documents, etc.);
— Events (forthcoming events organised by PIC/S);
— Activities of PIC/S (training, harmonisation of GMDP, compliance, etc.);
— PIA Academy — the PIC/S Inspectorates’ Academy.
For persons, who are unfamiliar with PIC/S, we strongly recommend that they first read the PIC/S information brochure (see below «Related documents», which provides a short, general overview on PIC/S.
For general enquiries, which are not addressed in the Frequently Asked Questions, you are welcome to contact the PIC/S Secretariat.
International Co-operation
PIC/S has been a pioneer organisation in the field of pharmaceutical inspections and Good Manufacturing Practice (GMP). It has successfully adapted to a constantly changing environment, in particular globalisation. It is the only organisation worldwide which exclusively deals with GMP. PIC/S’ mandate will as from 2023 be expanded to GxP with primary focus on GMDP in the field of training and standards, in line with PIC/S new mission to strive to improve public health by leading development and implementation of inspection frameworks for human and veterinary medicines through harmonisation of standards and offering world class training to regulatory inspectors around the globe.
This is achieved by harmonising inspection procedures worldwide, by developing common standards in the field of GMP, by providing training opportunities to inspectors and by facilitating co-operation and networking between competent authorities, regional and international organisations, thus increasing confidence, inspection reliance and avoiding duplication of efforts as well as wasting of resources.
PIC/S is, however, not alone to handle GMP. There are other organisations, which are also involved in this field, although — unlike PIC/S — the GMP part of their activities may only represent a fraction of their total activities.
PIC/S has relations with the following organisations (in alphabetical order):
| ASEAN | Association of South East Asian Nations |
| EC | European Commission |
| ECA | European Compliance Academy |
| EDQM | European Directorate for the Quality of Medicines |
| EMA | European Medicines Agency |
| EEA HMA | Heads of Medicines Agencies of the European Economic Area |
| ICH | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use |
| ICMRA | International Coalition of Medicines Regulatory Authorities |
| IFPMA | International Federation of Pharmaceutical Manufacturers Associations |
| ISPE | International Society for Pharmaceutical Engineering |
| PDA | Parenteral Drug Association |
| UNICEF | United Nations International Children’s Emergency Fund |
| WHO | World Health Organization |
| WOAH | World Organisation for Animal Health |
While relations with the European Union are of a privileged nature, due to the fact that many PIC/S Participating Authorities are also Competent Authorities of EU Member States, PIC/S aims at remaining impartial and avoiding to give more importance to one organisation over another. All organisations are treated equally.
Co-operation between PIC/S and other organisations are based on the principle of complementarity. Where PIC/S Participating Authorities are already actively co-operating, PIC/S as an organisation strives to not duplicate Members’ efforts. As human and financial resources are getting scarce at the level of national authorities as well as at the level of international organisations, the duplication of tasks with other organisations must be avoided at all costs.
PIC/S is thus increasingly focusing on its added-value and specificity. At the same time, in a world, which has become increasingly globalised, PIC/S aims at turning into a more global and efficient organisation and harmonise international efforts in the field of GMP. This is what PIC/S aims to achieve through its international co-operation efforts.
Associated Partner Organisations
PIC/S has signed co-operation agreement with the following six organisations:
- European Commission (EC);
- European Medicines Agency (EMA);
- European Directorate for the Quality of Medicines (EDQM);
- United Nations International Children’s Emergency Fund (UNICEF);
- World Health Organization (WHO);
- World Organisation for Animal Health (WOAH).
Other Organisations
Without having institutionalised its relations, PIC/S co-operates with an increasing number of organisations, which are also active in the field of GMDP.
Professional Organisations & Industry
Since the manufacturer is at the heart of the GMP process, it is essential for PIC/S to maintain good relations with industry and professional organisations, notably those more active in the field of regulation, guidance documents and training. The support of industry associations and professional organisations to the goals of PIC/S is a prerequisite for the latter’s successful expansion. As a matter of fact, industry is generally favourable to PIC/S’ expansion: the harmonisation of GMP facilitates trade and also means fewer inspections for manufacturers. The latter are increasingly worried by the multiplication and duplication of inspections, which means not only more fees but also more staff immobilised and possibly a lower-than-usual production output during these inspections.
PIC/S Secretariat
26, rue de Saint-Jean
1203 — Geneva
Switzerland
Co-operation with ICH
A new Memorandum of Understanding (MoU) between PIC/S and ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) was signed in October 2023.
PIC/S Events in Bangkok
6 — 10 November 2023
The Thailand Food and Drug Administration (Thai FDA), Ministry of Public Health, hosted the following events in Bangkok (Thailand) on 6-10 November 2023: PIC/S Committee meeting, PIC/S Executive Bureau meeting and PIC/S Annual Seminar.
Election of New PIC/S Chairperson and Executive Bureau
A new PIC/S Chairperson and Executive Bureau were elected as from 1 January 2024 by the PIC/S Committee at its meeting in Bangkok (Thailand) on 6-7 November 2023.
Accession of Saudi Arabia / SFDA to PIC/S
At its meeting in Geneva on 11-12 May 2023, the PIC/S Committee invited the Saudi Food and Drug Authority (SFDA) to join the Scheme as from 1 July 2023. SFDA will become PIC/S’ 56th Participating Authority.
Accession of Bulgaria / BDA to PIC/S
At its meeting in Geneva on 11-12 May 2023, the PIC/S Committee invited the Bulgarian Drug Agency (BDA) to join the Scheme as from 1 July 2023. BDA will become PIC/S’ 55th Participating Authority.
By-Election of New PIC/S Deputy Chair and New SC on Strategic Development Chair (2022-2023)
At its meeting in Geneva on 11-12 May 2023, the PIC/S Committee elected a new PIC/S Deputy Chairperson, Mr Jacques Morénas (France / ANSM), and a new PIC/S Sub-Committee on Strategic Development (SCSD) Chair, Ms Jennifer Burnett (Australia / TGA).
PIC/S 50th Anniversary
Participants attending the PIC/S 50th Anniversary symposium, which took place in Dublin (Ireland) on 4 October 2022, hosted by Ireland / HPRA.
PIC/S 50th Anniversary & 2022 PIC/S Seminar
3 — 7 October 2022
The PIC/S Committee is pleased to celebrate the 50th Anniversary of the Pharmaceutical Inspection Convention / Co-operation Scheme (PIC/S) in Dublin (Ireland), on 4 October 2022, back-to-back with the 2022 PIC/S Annual Seminar on 5-7 October 2022.
About
- PIC/S is the abbreviation and logo used to describe both the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) operating together in parallel.
- More about PIC/S
News & events
- Co-operation with ICH
- 2024 Wishes and Video Message from New PIC/S Chairperson, Mr Jacques Morénas
PIA Academy
The PIC/S Inspectorates’ Academy (PIA) is a PIC/S initiative to set up a web-based educational centre under the PIC/S umbrella which aims at harmonising and standardising GMP training at an international level.
It’s motto is «Inspection Excellence Through Harmonised Training«
Latest publications
- PIC/S Brochure 2023
- Participating Authorities
- Annual Report 2022
Current activities
- GM(D)P Harmonisation
- Compliance
- Training
- Strategic Development
- Expert Circles
- Communication
- Budget, Risk and Audit
Newsletter
Subscribe now to our Newsletter to be kept up-to-date with what happens at PIC/S.
Photos > All photos
Members
There are currently 56 PIC/S Participating Authorities worldwide, including:
Глоссарий фармацевтических и GMP-терминов с объяснением значения
В данной рубрике сайта GMP-inspection.com наши переводчики приводят значения и объяснения различных специализированных терминов из сферы фармацевтики и GMP (надлежащей производственной практики).
PIC/S
PIC/S — это сокращение от Pharmaceutical Inspection Co-operation Scheme, что переводится как «Схема сотрудничества в области фармацевтической инспекции». Это международная организация, созданная для сотрудничества и согласования в области регулирования и инспекции фармацевтических производств.
Основные цели и функции PIC/S включают:
- Согласование стандартов: PIC/S помогает разработке и согласованию стандартов и нормативных требований в области фармацевтической инспекции и регулирования.
- Обмен информацией: Организация обеспечивает обмен информацией и опытом между регулирующими органами в области фармацевтики, что помогает улучшить их способность проводить инспекции и контролировать производство лекарств.
- Сотрудничество: PIC/S способствует сотрудничеству между регулирующими органами разных стран в области фармацевтической инспекции, что помогает сократить дублирование усилий и ресурсов.
- Обучение и развитие кадров: Организация поддерживает обучение и развитие инспекторов и других специалистов, работающих в сфере фармацевтической инспекции.
- Разработка руководящих документов: PIC/S разрабатывает руководящие документы и рекомендации для облегчения соблюдения стандартов и требований в области фармацевтической инспекции.
Членами PIC/S могут быть национальные и региональные регулирующие органы, которые проводят инспекции фармацевтических производств и регулируют фармацевтическую промышленность. Страны-члены сотрудничают в рамках этой организации, чтобы улучшить качество и безопасность фармацевтических продуктов и обеспечить их соответствие международным стандартам.