The Pharmaceutical Inspection Co-operation Scheme (PIC/S) plays a central role in promoting internationally harmonised Good Manufacturing Practice (GMP) inspection standards. Through common technical guidance, the assessment of inspectorates, inspector training and regulatory cooperation, it helps authorities develop more consistent approaches to pharmaceutical manufacturing oversight.

However, PIC/S is not a global regulatory authority and its membership does not establish automatic mutual recognition of GMP certificates or inspection results. Understanding this distinction is essential for manufacturers operating across multiple regulatory jurisdictions.

What is PIC/S?

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was established on 2 November 1995 as an extension to the Pharmaceutical Inspection Convention (PIC), which was signed in October 1970 and entered into force in 1971.

The Convention and the Scheme operate in parallel and are collectively referred to as PIC/S. However, they have different legal foundations. The PIC Convention was established as an international convention, whereas the PIC Scheme is a non-binding, informal cooperation arrangement between regulatory authorities responsible for GMP inspections of human and veterinary medicinal products.

PIC/S aims to harmonise inspection procedures internationally by developing common GMP standards, providing training opportunities for inspectors, assessing inspectorates and facilitating cooperation between competent authorities and international organisations.

As of November 2026, PIC/S comprises 57 Participating Authorities worldwide, representing regulatory systems across Europe, the Americas, Asia, Africa and Australasia.

Participation is open to authorities able to demonstrate an inspection system comparable to those operated by existing members. Membership therefore involves an assessment of regulatory and inspection capabilities rather than simply a formal declaration of cooperation.

Harmonising GMP standards and guidance

The PIC/S GMP Guide is the principal technical instrument supporting international GMP harmonisation.

The Guide provides a common reference for participating inspectorates and helps promote consistent interpretation of manufacturing requirements across different regulatory systems.

The PIC/S GMP Guide and the European Union GMP Guide have been developed in parallel since the late 1980s and are practically identical in terms of GMP requirements. This alignment supports a common technical approach among authorities operating under different legal frameworks.

However, the documents are not identical in every detail. For example, the PIC/S Guide uses the term Authorised Person, whereas the EU GMP Guide uses Qualified Person. The PIC/S version also removes references to EU-specific legislation.

Beyond the main GMP Guide, PIC/S develops and promotes technical guidance covering different aspects of pharmaceutical manufacturing and inspection. Its publications include recommendations on quality systems for pharmaceutical inspectorates, qualification and validation, and the manufacture of active pharmaceutical ingredients.

These documents help inspectors and regulatory authorities address emerging manufacturing technologies, evolving scientific knowledge and new challenges in quality assurance.

Assessing the competence of GMP inspectorates

Common technical standards alone cannot guarantee consistent inspection outcomes. The competence, organisation and operational procedures of the inspectorates applying those standards are equally important.

PIC/S therefore operates a structured accession and assessment system through which regulatory authorities demonstrate that their GMP inspection arrangements meet the Scheme’s requirements.

The principal membership requirements include:

• an appropriate legal framework governing medicinal products
• a GMP Guide equivalent to the PIC/S Guide or the EU GMP Guide
• a GMP inspectorate meeting PIC/S quality system requirements
• appropriately qualified and experienced GMP inspectors

The assessment process examines the regulatory framework, organisation and operational capabilities of the inspectorate. It may include a review of documentation, an assessment of the quality system and, where necessary, on-site assessment and follow-up visits.

Membership is not a permanent confirmation of compliance. Existing Participating Authorities are also subject to regular reassessment to establish whether they continue to meet PIC/S requirements.

This mechanism is important because it provides a common basis for evaluating inspectorate capabilities and maintaining confidence in the quality of GMP oversight across participating regulatory systems.

Training inspectors and harmonising inspection practices

A common GMP Guide does not automatically produce identical inspection practices. Inspectors must also develop comparable technical knowledge, professional skills and approaches to evaluating compliance.

PIC/S treats inspector training as an essential part of its harmonisation activities. Its programmes combine theoretical learning, professional exchange and practical experience.

The main training mechanisms include:

• Training Seminars: PIC/S organises annual seminars focusing on selected GMP topics. These events bring together inspectors from different regulatory systems to discuss technical developments, regulatory challenges and inspection practices.
• Expert Circles: Specialist groups provide opportunities for inspectors to exchange experience, discuss specific technical areas and contribute to the development of guidance documents. Their work covers subjects requiring specialised GMP knowledge.
• Joint Visits Programme (JVP): Under the Joint Visits Programme, inspectors from three different countries observe GMP inspections conducted in participating countries. The programme enables them to compare inspection procedures, techniques and interpretations of GMP requirements.
• Coached Inspections Programme (CIP): This programme pairs a less experienced inspector with an experienced colleague during a routine inspection. It provides practical training and helps develop inspection skills under real working conditions.
• New inspector training courses: These courses are designed to develop the practical competencies required to assess compliance with the PIC/S GMP Guide.
• PIC/S Inspectorates’ Academy (PIA): Established in 2014 and officially launched in 2016, the PIC/S Inspectorates’ Academy provides a web-based educational centre for regulatory inspectors. It brings together training activities, educational materials and opportunities for professional discussion and knowledge exchange.

Together, these programmes address differences that cannot be resolved through written standards alone. They support a more consistent understanding of GMP requirements, inspection methodology and the classification of deficiencies.

International regulatory cooperation

PIC/S also provides a framework for cooperation between regulatory authorities and international organisations involved in pharmaceutical quality and manufacturing oversight.

Its institutional cooperation includes seven Associated Partner Organisations:

• European Commission (EC)
• European Medicines Agency (EMA)
• European Directorate for the Quality of Medicines & HealthCare (EDQM)
• World Health Organization (WHO)
• United Nations Children’s Fund (UNICEF)
• World Organisation for Animal Health (WOAH)
• African Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD)

Cooperation agreements generally cover inspector training, participation in meetings and information exchange. These arrangements are legally non-binding and define the scope of cooperation between PIC/S and the respective partner organisations.

PIC/S also maintains separate relationships with other international bodies. Its cooperation with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is particularly relevant to the implementation of guidelines affecting GMP inspection activities.

PIC/S has been an ICH Observer since 2017. In October 2023, the two organisations signed a Memorandum of Understanding intended to strengthen cooperation on relevant ICH guidelines and inspector training.

The relationship with EMA is especially important for international GMP harmonisation. Cooperation includes inspector training, participation in each other’s meetings, the development of aligned guidance and support for the assessment of prospective PIC/S Participating Authorities.

These arrangements help reduce duplication of technical work and make better use of regulatory expertise and resources.

What PIC/S membership does — and does not — mean

PIC/S membership indicates that a regulatory authority’s GMP inspection system has undergone an assessment and has been accepted as meeting the Scheme’s requirements.

It provides a basis for professional cooperation, information exchange and greater confidence between participating inspectorates.

However, membership does not create an automatic legal obligation for one authority to accept another member’s inspection results, GMP certificates or regulatory decisions.

This distinction is particularly important when discussing international regulatory reliance.

Mutual Recognition Agreements (MRAs) establish specific legal arrangements under which participating authorities may recognise defined inspection outcomes or other regulatory activities, subject to the terms of the relevant agreement.

PIC/S membership alone does not provide the same legal effect. It supports the technical and institutional conditions for cooperation but does not replace national legislation or separate recognition agreements.

For manufacturers, this means that participation by a regulatory authority in PIC/S should not be interpreted as a guarantee that an inspection conducted by another member will be accepted without further assessment.

The mechanisms and legal implications of MRAs are examined separately in our article, Mutual recognition of GMP inspections: How international agreements work.

Why PIC/S matters to pharmaceutical manufacturers

Pharmaceutical manufacturing and supply chains increasingly extend across national and regional borders. A single medicinal product may involve manufacturing sites, active pharmaceutical ingredient suppliers and contract manufacturers located in several jurisdictions.

In this environment, differences in GMP inspection standards, procedures and regulatory capabilities can make compliance more complex and create additional regulatory work.

PIC/S contributes to addressing these challenges by promoting common technical standards, assessing inspectorates, developing inspector competencies and facilitating international cooperation.

For manufacturers, these activities support greater consistency in the interpretation and assessment of GMP requirements across participating regulatory systems.

They can also contribute to more effective regulatory cooperation and help reduce unnecessary duplication of technical work. However, they do not eliminate inspections by individual authorities or remove the obligation to comply with applicable national and regional legislation.

PIC/S is therefore best understood as an international framework for building comparable GMP inspection capabilities and professional confidence between regulatory authorities. Its role is not to establish a global regulator or a universal system of mutual recognition, but to strengthen the technical foundations on which international pharmaceutical inspection cooperation can operate.