Pharmaceutical inspection convention M. Pharmacy
- 1. By : Priyanka Patil First Year M. Pharm
- 2. • PIC/S is a combine term used for the execution of activities of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme. • PIC/S was established to harmonize, educate, and update aspects relating to Good Manufacturing Practice among member countries. PIC/S is also a body that even harmonized relation among regulatory authorities and governments. • The presentation helps in understanding the origin, purpose, objective, role and functions of PIC/S.
- 3. • In 1995, PIC/S was established as a provision to streamline with long back established Pharmaceutical Inspection Convention of 1970 with some flexibility. • Formation of a PIC Scheme, less formal, more flexible, with no legal status that in turn brings understanding between health authorities. • Thus PIC/S is a parallel scheme of both Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme. PIC/S has brought understanding among health and led to joint execution of activities among health authorities and governments.
- 4. • The main objective is to harmonize Good Manufacturing Practice requirements, bring about uniform-mutual recognition inspections, educate and exchange information, among different countries and attain mutual confidence of drug regulatory authorities • The role of PIC scheme is to safe guard public health by providing good quality medicines by bringing a harmonization in Good Manufacturing Practice among countries. • To achieve this harmonization, regular awareness along with training, sharing information and experience, implementing procedures to be followed relating to manufacture and quality control of medicinal products so that equivalent standards among countries can be implemented
- 5. • To meet the objectives of PIC/S in terms of harmonisation of GMP • The committee makes recommendations, update and improve GMP, promote cooperation relating to quality assurance of inspections and quality system, educate the authorities by means of training and exchange of information and helps in bringing out new guidelines relating to manufacturing and quality control of medicinal products. • Decides suggestions and changes necessary for the country to become a member of PIC/S.
- 6. • PIC/S brings about an international harmonization among countries with relating to Good Manufacturing Practice, quality maintenance systems of medicinal products. • In addition , implementation of high standards of quality along with mutual understanding among members is achieved. • PIC/S brings about a single network system relating to GMP of medicinal products • It helps member regulatory authorities in sharing, facilitating, recalling, concluding aspects relating to manufacture, quality and inspection systems among inspectorates, pharmaceutical industries. • PIC/S also brings about single window export facilitation to enhance marketing of the medicinal products.
- 7. • PIC/S provides guide lines for industry, inspectorates and inspectors as mentioned below: Guidance to Industry: • PE 009-9 : Good Manufacturing Practice for Medicinal Products (Part I, II, Annexes) • PI 010-4 : Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects Guidance to Inspectorate: • PIC Convention • PIC/S Scheme • Participating Authorities & Partners • PI 002-3 : Quality System Requirement for Pharmaceutical Inspectorate • PI 013-3 : Standard Operating Procedure PIC/S Inspection Report Format
- 8. Guidance to Inspectors: • PI 009-3 : Aide-Memoire Inspection of Utilities • PI 021-2 : Aide-Memoire on GMP Particularities for Clinical Trial Products • PI 023-2 : Aide-Memoire on Inspection of Quality Control Laboratories • PI 024-2 : Aide-Memoire on Inspection of Biotech • PI 025-2 : Aide-Memoire on Medicinal Gases • PI 028-1 : Aide-Memoire on Packaging • PI 030-1 : Aide-Memoire on the Inspection of APIS • PE 005-3 : PIC/S GMP Guide for Blood Establishments
- 9. • Guidance to Inspectors: • PE 010-3 : Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments • PI 005-3 : Guidance on Parametric Release • PI 006-3 : Validation Master Plan Installation and Operational Qualification Non-Sterile • Process Cleaning Validation • PI 007-6 : Validation of Aseptic Processes • PI 008-3 : PIC/S Guide to Inspections of Source Plasma Establishments and Plasma
- 10. • Warehouses (Inspection Guide) • PI 011-3 : Good Practices for Computerized Systems in Regulated GXP Environments • PI 012-3 : Recommendation on Sterility Testing • PI 014-3 : Isolators used for Aseptic processing and Sterility Testing • PI 032-2 : Technical Interpretation of Revised Annex 1 to PIC/S GMP Guide