Pharmaceutical Inspection Co-operation Scheme (PIC/S)

1. Pharmaceutical Inspection Co-operation Scheme (PIC/S) Che Mohd Zin Bin Che Awang Pengarah Biro Pengawalan Farmaseutikal Kebangsaan

2. Pharmaceutical Inspection Convention (PIC) • Founded by European Free Trade Association (EFTA) in 1971 • A legal Treaty between countries • Initially only 10 member countries – Austria, Denmark, Finland, Iceland, Liechtenstein, Norway, Portugal, Sweden, Switzerland and UK • 1993 – 18 members : Australia, Austria, Belgium, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Liechtenstein, Norway, Portugal, Romania, Sweden, Switzerland, UK

3. Original Goals of PIC • Establish Harmonised GMP requirements • Develop mutual recognition of inspections • Implement a uniform inspection system • Conduct training of Inspectors • Build mutual confidence

4. Formation of Pharmaceutical Inspection Co-operation Scheme (PIC/S) • After 1993, no new members of PIC possible • Under EU law, only EC authorised to sign agreements with other countries • Amendment of Convention difficult • PIC/S was thus developed and implemented

5. Features of PIC/S • Started operations - 2 November 1995 • International agreement between pharmaceutical inspection authorities • Provides an active and constructive co-operation in GMP • Networking between competent authorities • Development and maintenance of mutual confidence • Exchange of information & experience on GMP • Mutual training of inspectors • Developing quality systems for Inspectorates • International harmonisation of GMP

6. Members of PIC/S • 24 participating authorities – November 2000 • Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Liechtenstein, Netherlands, Norway, Portugal, Romania, Singapore, Slovak Republic, Spain, Sweden, Switzerland and United Kingdom

7. Applications for Membership • Greece • Malaysia • Chinese Taipei (Taiwan) • Estonia • Latvia • UK-based Veterinary Medicine Directorate

8. Accession Procedure • Useful documents – Guidelines for accession to PIC/S, Application form, Questionnaire on National Inspection Systems

9. Accession Procedure • Steps to Accession – General interest and commitment, Written application plus supporting documents, Appointment of Rapporteur to evaluate, Applicant invited to Committee meeting to answer questions, PIC/S delegation undertakes assessment visit – observe 3 or 4 inspections, Delegation report issued to applicant & committee, Committee decides on membership

10. PIC/S Press Release – Nov 2000 • PIC/S Committee Meeting & PIC/S Seminar, October 2000, Colmar, France • 41 delegates and observers from 25 countries • Reviewed applications from Greece, Malaysia and Chinese Taipei • Assessment visits to Estonia and Latvia scheduled for November / December 2000 • Lithuania and UK-based Veterinary Medicine Directorate (VMD) expressed interest to join

11. PIC/S Press Release – Nov 2000 • EU Heads of Inspection Agencies expressed desire to adopt a similar scheme. Proposal to adopt PIC/S – EU re-assessment procedure • Co-operation with the EMEA • Training of inspectors - Working Group on the Training of Inspectors • PIC/S Joint Visits Program – 17 joint visit groups now operational • PIC/S Seminars • PIC/S Expert Circles

12. Future PIC/S Seminars • 2001 – Prague, Czech Republic – Utilities Used By The Manufacturer Of Pharmaceuticals • 2002 – Canada - The Interface Between Good Clinical Practice (GCP) and GMP in the Manufacture and Audit of Clinical Trial Products • 2003 – Slovak Republic – Inspection of Quality Control

13. PIC/S On Line • PIC/S Web site launched on 12 May 2000 • http: //www.picscheme.org

14. Benefits of Joining PIC/S • Forced improvements and upgrading • Increase knowledge and gain more experience in GMP and inspections • Networking and interactive communication • Exchange of useful information • To facilitate export of medicinal products • To facilitate mutual recognition agreements

15. Efforts Towards Becoming a Member of PIC/S • Strengthening the GMP Inspectorate via co-operation with the Pharmacy Division, Ministry of Health Malaysia • Adoption and implementation of European GMP Guidelines ( Eudralex ) to upgrade GMP of local manufacturing premises • Implementation of validation requirements and separate facilities requirement for cephalosporins • Implementation of a quality system for inspection and licensing • New revised format for Site Master File • Modular training in International GMP for industry

16. Efforts Towards Becoming a Member of PIC/S • To focus on training on documentation aspects for traditional medicines manufacturers • To upgrade GMP for traditional medicines in accordance to Eudralex • Commitment and participation in PIC/S activities • Establishing contacts and networking with PIC/S • To propose a time-frame approach in the implementation of GMP for active pharmaceutical ingredients (API), clinical trial products, medicinal gases, blood banks, veterinary products, and hospital pharmacies – 8th Malaysia Plan.

17. Target of Becoming a Member of PIC/S • Assessment by PIC/S delegation – 12 to 16 March 2001 • PIC/S Inspection Team – Australia, Switzerland, United Kingdom, Singapore, Slovak Republic, and PIC/S Secretariat • 4 factories to be inspected ( sterile, non-sterile, traditional and another small manufacturer ) • Next PIC/S Committee Meeting – May 2001 • Target - Malaysia to become member of PIC/S by May 2001

18. Plans After Becoming a Member of PIC/S • To collaborate with industry towards establishing mutual recognition agreements or co-operative arrangements with other countries ( EU, Australia, Singapore and others ) • To focus on continuous GMP training program • To collaborate with industry towards further upgrading GMP of local traditional medicines premises • To participate in joint inspections and joint visit programs with PIC/S • To conduct GMP inspections on foreign manufacturing premises ( non-PIC/S countries )

19. Terima Kasih