pics gmp history (ppt)

A: The Pharmaceutical Inspection Co-operation Scheme (PIC/S)

Q: 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.

A: PIC/S mission

Q: Is to lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates in the field of medicinal products.

A: The history of PIC/S (Pharmaceutical Inspection Co-operation Scheme)

Q: Spans over five decades, evolving from a treaty among a handful of Western European nations into a global network of regulatory authorities.

A: October 1972

Q: In ________, the European Free Trade Association (EFTA) established the Pharmaceutical Inspection Convention (PIC) under the official name "The Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products"

A: European Free Trade Association (EFTA)

Q: In October 1972, the ________ established the Pharmaceutical Inspection Convention (PIC) under the official name "The Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products"

A: Pharmaceutical Inspection Convention (PIC)

Q: Established in October 1972 by the European Free Trade Association (EFTA) under the official name "The Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products"

A: "The Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products"

Q: The official name under which the European Free Trade Association (EFTA) established the Pharmaceutical Inspection Convention (PIC) in October 1972.

A: 10 EFTA nations (Austria, Denmark, Finland, Iceland, Liechtenstein, Norway, Portugal, Sweden, Switzerland, and the United Kingdom)

Q: Original Members of PIC (1972).

A: Mutual recognition of GMP inspections to eliminate duplicate site audits and streamline cross-border drug trade

Q: Primary Goal of PIC (1972).

A: A formal, legally binding international treaty signed between sovereign states

Q: Structure of PIC (1972).

A: By the early 1990s

Q: ________, the PIC framework hit a critical legal roadblock.

A: European Union law

Q: Was updated so that individual EU member states were no longer legally permitted to sign treaties with non-EU countries independently; only the European Commission was authorized to do so.

A: November 2, 1995

Q: To bypass this legal obstacle without abandoning their progress, member states created a new, parallel structure on ________: the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme).

A: Pharmaceutical Inspection Co-operation Scheme (PIC Scheme)

Q: A new, parallel structure created on November 2, 1995 to bypass the legal obstacle without abandoning their progress.

A: Legally binding treaty between countries

Q: Legal Nature of PIC (1972).

A: Informal agreement between health authorities

Q: Legal Nature of PIC Scheme (1995–Present).

A: Heads of State / Governments

Q: Signatories of PIC (1972).

A: Regulatory bodies (e.g., US FDA, TGA, MHRA)

Q: Signatories of PIC Scheme (1995–Present).

A: European-centric

Q: Scope of PIC (1972).

A: Global

Q: Scope of PIC Scheme (1995–Present).

A: MHRA

Q: Medicines and Healthcare products Regulatory Agency- United Kingdom

A: TGA

Q: Therapeutic Goods Administration- Australia

A: Australia (TGA), Canada (Health Canada), the United States (US FDA in 2011), Japan (PMDA), and dozens of agencies across Asia, Latin America, and Africa

Q: Landmark additions since 1995 after removing the requirement for a formal political treaty allowed non-European regulatory agencies to join rapidly.

A: 57 participating authorities

Q: Today, PIC/S consists of ________.

A: GMP Harmonization

Q: Developing identical standards so inspectors worldwide evaluate sites using the same yardstick.

A: Inspector Training

Q: Running advanced training programs through the PIC/S Inspectorates' Academy (PIA).

A: Building Trust

Q: Conducting audits of member authorities to ensure everyone enforces GMP standards with equal rigor.

A: The PIC Convention (1972)

Q: Founded as a formal international treaty among 10 EFTA countries to recognize each other's manufacturing inspections.

A: The Legal Shift (Early 1990s)

Q: Incompatibility between European Law and the formal PIC Treaty prevents new countries from joining.

A: Formation of PIC/S (1995)

Q: The PIC Scheme is launched as an informal, non-binding arrangement between regulatory agencies (rather than countries).

A: Global Expansion (2000s- Present)

Q: Major global regulators join, expanding membership beyond Europe to North America, Asia, and Latin America.

A: The adoption of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP in the Philippines

Q: Represents a major shift toward aligning local drug manufacturing with international standards.

A: Regional trade commitments and a push for global regulatory harmonization

Q: Driven primarily by ________, the transition fundamentally reshaped how the Philippine Food and Drug Administration (FDA) regulates pharmaceuticals.

A: WHO- Based Regulations (1974 & 1999)

Q: The Philippines initially relied on WHO guidelines for Good Manufacturing Practice, formalized under Administrative Order (AO) No. 220 s. 1974 and later upgraded via AO 43 s. 1999.

A: Official Adoption (AO 2012-0008) (June 2012)

Q: The Department of Health (DOH) issued Administrative Order No. 2012-0008, officially adopting the PIC/S Guide for Good Manufacturing Practice for Medicinal Products as the national standard.

A: Administrative Order No. 2012-0008

Q: In June 2012, the Department of Health (DOH) issued ________, officially adopting the PIC/S Guide for Good Manufacturing Practice for Medicinal Products as the national standard.

A: ASEAN MRA Integration (January 2020)

Q: The Philippines FDA became officially listed under the ASEAN Mutual Recognition Arrangement (MRA) on GMP, enabling PIC/S-based inspection reports to be recognized across member states.

A: Application for Full Membership & Auto-Updates (2023- Present)

Q: The FDA PH formally submitted its application for full PIC/S membership in June 2023. Under local regulations, any revisions to the PIC/S Guide (such as updates to Annex 1) are automatically adopted into Philippine regulation.

A: June 2023

Q: The FDA PH formally submitted its application for full PIC/S membership in ________.

A: ASEAN Harmonization

Q: As part of the ASEAN Economic Community, member states agreed to harmonize drug regulatory frameworks using PIC/S standards as the common baseline.

A: Export Capability

Q: Adopting PIC/S allows Philippine pharmaceutical manufacturers to produce drugs that meet global market entry criteria, making local exports far more viable.

A: Foreign Manufacturer Oversight

Q: The regulatory shift gave the Philippine FDA a structured mechanism to assess foreign manufacturing sites supplying drugs into the country through Foreign GMP Clearance procedures.

A: Local Manufacturers Practical Impact

Q: Must maintain strict compliance with updated PIC/S guides (e.g., modern contamination control strategies, environmental monitoring, data integrity standards). Re-inspections occur on a risk-based schedule.

A: Foreign Manufacturers (Importers) Practical Impact

Q: To obtain a Foreign GMP Clearance to import drugs into the Philippines, foreign facilities must either present proof of inspection by a PIC/S-recognized authority or undergo an on-site inspection by the PH FDA.

A: Local Regulatory Inspectors Practical Impact

Q: PH FDA inspectors undergo specialized training via the FDA Academy to ensure their audit methods match the standards expected by global PIC/S members.