PIC/S - Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

What PIC/S - Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme does

PIC/S is the joint operational framework of the Pharmaceutical Inspection Convention (PIC, signed 1970) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme, established 1995), constituting an intergovernmental organisation headquartered in Geneva, Switzerland. Its core function is leading the international development, implementation, and maintenance of harmonised Good Manufacturing Practice (GMP) standards and quality systems for inspectorates in the field of medicinal products. The organisation serves national pharmaceutical inspectorates (Competent Authorities) from 57 Participating Authorities across 55+ jurisdictions as of January 2026.

PIC/S's core "products" are harmonised standards and guidance — principally the PIC/S GMP Guide (PE 009, equivalent to the EU GMP Guide since 1989), the GDP Guide (PE 011), and an extensive library of aide-memoires, Q&A documents, and concept papers covering APIs, sterile products, biologicals, radiopharmaceuticals, computerised systems, quality risk management, cross-contamination, data integrity, blood/tissues/ATMPs, and pharmacovigilance. Its operational platform is the PIC/S Inspectorates' Academy (PIA), a web-based educational centre delivering standardised GMP training, supported by Expert Circles, Joint Visit Programmes, and Coached Inspection Programmes. The technology substrate is principally regulatory and procedural — no commercial software product, APIs, or AI/ML capabilities are evidenced.

Revenue comes from annual membership fees paid by Participating Authorities and one-time application fees from authorities entering the multi-year accession process (up to 6 years, with applicants paying 80% of the membership fee during assessment). Specific fee amounts are not publicly disclosed. Distribution occurs through the PIC/S website, the PIA Academy, annual seminars, and expert circle meetings, with relationships to 7 Associated Partner Organisations (WHO, EMA, EDQM, EC, UNICEF, WOAH, AUDA-NEPAD) and privileged relationships with professional associations (ISPE, PDA, ECA). The organisation is governed by a Committee of Participating Authorities with an elected Chairperson and Executive Bureau, and supported by a small Secretariat of approximately 10 employees — a lean central staff typical of intergovernmental regulatory bodies.

Name

PIC/S - Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

Legal name

PIC/S - Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

Website

https://picscheme.org

Company type

Private

Founded year

1971

Operating status

Operating

Headcount range

1–10 employees

Short description

PIC/S is an intergovernmental organisation, headquartered in Geneva, that harmonises Good Manufacturing Practice (GMP) standards and trains pharmaceutical inspectors for 57 Participating Authorities across 55+ jurisdictions worldwide, supporting mutual recognition of inspections.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulatory Standards and Inspection Services

NAICS

Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors (926150)

akta.pro primary industry

Manufacturing Quality, GMP Inspections & Compliance (HLAJADAG)

akta.pro secondary industries

Drug Regulators (Human Pharmaceuticals) (HLAJADAA), Clinical Trials Authorization & Oversight (GCP) (HLAJADAF), Pharmacovigilance Quality & Compliance (PV audits, QPPV support, PSMF) (HLAGAKAH)

Keywords

• Pharmaceutical inspection
• GMP harmonization
• Regulatory standards
• Inspector training
• Mutual recognition

Headquarters

HQ city

Geneva, Geneva

HQ country

Switzerland

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Others

Revenue model

1. Membership Fees: Participating Authorities pay annual membership fees. Applicants during the assessment process pay annual fees corresponding to 80% of the full membership fee.
2. Application Fees: One-time application fee charged when an authority submits its membership application. The complete application and all supporting documents must be received before assessment begins.

Pricing tiers

Go-to-market motion3 records

Distribution channels3 records

Marketing channels7 records

Core offering

PIC/S develops, implements and maintains harmonised GMP and GDP standards (PIC/S GMP Guide PE 009, GDP Guide PE 011 and specialised Annexes) and operates a global training and assessment infrastructure—principally the PIC/S Inspectorates' Academy (PIA)—for national pharmaceutical inspectorates. It assesses candidate Competent Authorities through a formal accession procedure, runs Expert Circles across specialised areas (APIs, computerised systems, blood/tissues/ATMPs, QRM, cross-contamination, GPV, GCP) and enables mutual recognition of GMP inspections between its 57 Participating Authorities.

Product overview

PIC/S is a regulatory harmonisation organisation operating two parallel frameworks - the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme). The organisation provides a portfolio of harmonised GMP/GDP guidelines and guidance documents (including PIC/S GMP Guide PE 009, GDP Guide PE 011, and various aide-memoires), supported by the PIA Academy which delivers web-based training programmes and expert circles covering specialised areas such as API inspections, computerised systems, quality risk management, blood/tissues/cells, cross-contamination control, pharmacovigilance, and clinical practices. The core offering is standards harmonisation and inspector training, not a unified software product.

Differentiator

Problem solved

Functional benefit

Brands

• PIA Academy (PIC/S Inspectorates' Academy): 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. Motto: 'Inspection Excellence Through Harmonised Training'.

Products and services

• PIC/S GMP Guide (PE 009) Main harmonised GMP standard covering medicinal products manufacturing, distribution and inspection requirements; includes Part I (basic GMP), Part II (ICH Q7 for APIs) and Annexes covering sterile products, biologicals, radiopharmaceuticals and computerised systems. Equivalent to the EU GMP Guide since 1989. Targeted at pharmaceutical inspectorates and manufacturers.
• PIC/S GDP Guide (PE 011) Guide to Good Distribution Practice for Medicinal Products covering supply-chain inspection requirements for Competent Authorities and pharmaceutical distributors.
• PIA Academy (PIC/S Inspectorates' Academy) Web-based educational centre under the PIC/S umbrella that harmonises and standardises GMP training internationally for inspectors from Participating Authorities; delivers seminars, expert circles, joint visits, coached inspections and specialised programmes (motto: 'Inspection Excellence Through Harmonised Training').
• Expert Circles Specialised expert groups covering API, Computerised Systems, GDP, Human Blood/Tissues/Cells & ATMPs, Quality Risk Management, Control of Cross-Contamination in Shared Facilities (CCCISF), Good Pharmacovigilance Practices (GPV) and Good Clinical Practices (GCP). The 8th GDP Expert Circle (Sept 2025) gathered 42 participants from 23 authorities.
• API International Training Programme International training programme comprising General Training on ICH Q7 (open to regulators and industry), Advanced Training (regulators only), and Q&A sessions for regulators and industry.
• PIC/S Accession Procedure (membership assessment service) Formal procedure through which Competent Authorities apply to become PIC/S Participating Authorities, including document submission, translation, assessment by a Rapporteur/Co-Rapporteur appointed by the PIC/S Committee, with a maximum 6-year timeframe.

Quantifiable outcome

• 160+ participants from 55 jurisdictions at 2025 Annual Seminar
• +2 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

25 partnerships are on record, tiered core, major and minor.

• AUDA-NEPAD (African Union Development Agency - New Partnership for Africa's Development)coreStrategic or Co-development PartnerPIC/S signed co-operation agreement with AUDA-NEPAD. The agreement covers training of Inspectors in GMDP, participation at meetings, and exchange of information. Located at 230, 15th Road, Midrand, Johannesburg, South Africa.
• European Commission (DG SANTE)coreStrategic or Co-development PartnerEuropean Commission became Associated Partner Organisation in 2022. Prior to joining, EC directly consulted on GMP-related guidance documents. In 2015, EC financially supported PIC/S International Training Programme on API. Located at BE - 1049 Brussels, Belgium.
• European Medicines Agency (EMA)coreStrategic or Co-development PartnerFirst agreement signed by PIC/S in 2007 (revised 2010, 2022). Covers training, exchange of information, and exchange of GMP inspectorate audit reports under EU JAP and PIC/S JRP. In 2022, new Working Arrangement signed for exchange of non-public information on medicinal products. Located at Domenico Scarlattilaan 6, NL - 1083 HS Amsterdam, The Netherlands.
• European Directorate for the Quality of Medicines (EDQM)coreStrategic or Co-development PartnerCo-operation agreement signed in 2007 covering Active Pharmaceutical Ingredients (APIs) and Blood, Tissues and Cells. Exchanges planned inspections with PIC/S, particularly in non-PIC/S countries. EDQM Inspectors regularly attend PIC/S training events. First Partner Organisation to officially host a PIC/S event. Located at 7 allee Kastner, CS 30026, FR - 67081 Strasbourg, France.
• UNICEFcoreStrategic or Co-development PartnerCo-operation agreement signed in 2008 with UNICEF Supply Division. GMDP Inspectors from UNICEF regularly participate in PIC/S training events and share inspection planning with PIC/S. Hosted 8th GDP Expert Circle meeting in Copenhagen. Located at Supply Division, Oceanvej 10-12, DK - 2100 Copenhagen O, Denmark.
• World Health Organization (WHO)coreStrategic or Co-development PartnerCo-operation agreement signed in 2009 (revised 2015). Relations date back to the beginning of PIC Convention when first PIC GMP Guide was based on WHO GMP Guide. WHO has observer status since 1994. GMP Inspectors from WHO Prequalification Programme regularly participate in PIC/S training. Located at Avenue Appia, 20, CH - 1211 Geneva 27, Switzerland.
• World Organisation for Animal Health (WOAH)coreStrategic or Co-development PartnerExchange of letters signed in 2019 defining co-operation in GMP standards and good quality for veterinary medicinal products including veterinary vaccines. Located at 12, rue de Prony, FR - 75017 Paris, France.
• International Society for Pharmaceutical Engineering (ISPE)majorStrategic or Co-development PartnerPrivileged relations maintained as one of three main professional associations. ISPE provides valuable comments on draft PIC/S guidance documents and provides speakers to PIC/S Seminars. Actively interested in supporting PIA Academy. PIC/S participated in ISPE China Annual Spring Conference 2014.
• Parenteral Drug Association (PDA)majorStrategic or Co-development PartnerPrivileged relations maintained as one of three main professional associations. PDA worked with PIC/S on API International Training Programme (ICH Q7). Provides comments on draft guidance documents and shares technical guidelines with PIC/S Inspectors. Open their training courses to Regulatory Authorities.
• European Compliance Academy (ECA)majorStrategic or Co-development PartnerPrivileged relations maintained as one of three main professional associations. Provides valuable comments on draft PIC/S guidance documents. Shares technical guidelines with PIC/S Inspectors. Interested in supporting PIA Academy.
• Association of South East Asian Nations (ASEAN)majorStrategic or Co-development PartnerPIC/S Membership is defined as essential criterion for ASEAN Sectoral MRA on GMP inspections. Exchange of letters signed in 2019 with ASEAN Pharmaceutical Product Working Group (PPWG) for GMP cooperation. One PIC/S Participating Authority acts as Liaison Officer between PIC/S and ASEAN.
• Heads of Medicines Agencies of the European Economic Area (EEA HMA)majorStrategic or Co-development PartnerLetter of agreement entered into force August 15, 2016. Cooperate on EEA Joint Audit Programme (JAP) and PIC/S Joint Reassessment Programme (JRP). Both programmes deemed equivalent. Audit schedules exchanged to avoid duplication.
• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)majorStrategic or Co-development PartnerPIC/S Observer since 2017. PIC/S originally developed API GMP Guide which became ICH Q7A in 2000. PIC/S handed over Q&A document to ICH in 2013, incorporated into ICH Q7 Q&A published 2016. Pilot launched May 1, 2020 on cooperation in ICH Q9 and Q12.
• International Coalition of Medicines Regulatory Authorities (ICMRA)majorStrategic or Co-development PartnerPIC/S supports ICMRA's objectives on better use and sharing of GMP resources. Since 2016, PIC/S represented in ICMRA 'GMP reliance framework on equivalency.' PIC/S Guidance on Inspection Reliance (PI 048-1) adopted April 2018. Since 2022, collaboration on Pharmaceutical Quality Knowledge Management System (PQ KMS).
• Organisation for Economic Co-operation and Development (OECD)minorStrategic or Co-development PartnerInvited PIC/S to participate in 2015 survey on international regulatory cooperation. PIC/S accomplishments highlighted, particularly in training. PIC/S invited to OECD meetings on international regulatory cooperation.
• APIC (Active Pharmaceutical Ingredients Committee)minorOthersListed among other industry and professional associations maintaining relations with PIC/S.
• ASTM InternationalminorOthersListed among other industry and professional associations maintaining relations with PIC/S.
• DIA (Drugs Information Association)minorOthersListed among other industry and professional associations maintaining relations with PIC/S.
• EFPIA (European Federation of Pharmaceutical Industries and Associations)minorOthersListed among other industry and professional associations maintaining relations with PIC/S.
• Global Self-Care FederationminorOthersListed among other industry and professional associations maintaining relations with PIC/S.
• IFPMA (International Federation of Pharmaceutical Manufacturers Associations)minorOthersListed among other industry and professional associations maintaining relations with PIC/S.
• ISCT (International Society for Cell & Gene Therapy)minorOthersListed among other industry and professional associations maintaining relations with PIC/S.
• RAPS (Regulatory Affairs Professionals Society)minorOthersListed among other industry and professional associations maintaining relations with PIC/S.
• SQA (Society of Quality Assurance)minorOthersListed among other industry and professional associations maintaining relations with PIC/S.
• VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products)minorStrategic or Co-development PartnerListed among other industry and professional associations maintaining relations with PIC/S. VICH focuses on veterinary medicinal products harmonization.

Scale indicators5 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• U.S. Food and Drug Administration (FDA): FDA is the US national regulator and a Participating Authority in PIC/S. It is much broader in scope than PIC/S (covering all regulated products and market authorization) but operates its own GMP inspection framework that PIC/S members often reference and rely upon.
• European Medicines Agency (EMA): EMA is the EU-wide medicines regulator with an EU GMP Guide that is equivalent to PIC/S GMP. EMA is broader than PIC/S (covering market authorization, pharmacovigilance, clinical trials) but is a key Associated Partner for PIC/S on GMP training and information exchange.

Direct peers

• International Coalition of Medicines Regulatory Authorities (ICMRA): ICMRA is a chief-level coalition of medicines regulators focused on supply-chain integrity and GMP reliance. PIC/S sits on ICMRA's GMP reliance framework and co-developed Inspection Reliance guidance, making it a directly comparable regulator-to-regulator collaboration body.
• European Directorate for the Quality of Medicines (EDQM): EDQM operates the European Pharmacopoeia and runs a CEP certification programme plus its own GMP inspections, particularly in non-PIC/S countries. It is the closest direct peer to PIC/S in scope and has a long-standing co-operation agreement with PIC/S covering APIs and Blood/Tissues/Cells.
• International Council for Harmonisation (ICH): ICH harmonizes technical requirements for pharmaceuticals across major regulatory regions. PIC/S is an ICH Observer since 2017 and originated ICH Q7; both organizations set pharmaceutical standards consumed by the same regulatory audience.
• World Health Organization (WHO) Prequalification Programme: WHO Prequalification inspects manufacturing sites of vaccines, medicines, and diagnostics for UN procurement. It is directly comparable to PIC/S because both operate GMP inspection frameworks for pharmaceutical manufacturers and regularly exchange inspectors at training events.

Others

• Parenteral Drug Association (PDA): PDA is a global industry association focused on parenteral and sterile manufacturing. It co-developed PIC/S's API International Training Programme on ICH Q7 and shares technical guidelines with PIC/S inspectors, making it a closely adjacent enabling organization.
• World Organisation for Animal Health (WOAH): WOAH is an Associated Partner of PIC/S for veterinary medicinal products and vaccines. It is comparable as an intergovernmental standards body setting quality requirements but operates in a different (animal health) domain.
• International Society for Pharmaceutical Engineering (ISPE): ISPE is a major industry professional association providing GMP training and guidance. It is a privileged partner that comments on PIC/S draft guidance and supports the PIA Academy, but it is industry-led rather than regulator-led.

Regional players

• ASEAN Pharmaceutical Product Working Group (PPWG): ASEAN PPWG coordinates pharmaceutical regulatory cooperation across Southeast Asia and uses PIC/S membership as an essential criterion for its GMP MRA. It is a comparable regional harmonization player but focused only on ASEAN geography.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/picscheme
• LinkedInlinkedin.com/company/picscheme

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about PIC/S - Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme