Pharmaceutical Inspection Co-operation Scheme (PIC/S)

Che Mohd Zin Bin Che AwangPengarah

Biro Pengawalan Farmaseutikal Kebangsaan

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

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

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

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

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

Applications for Membership

Greece Malaysia Chinese Taipei (Taiwan) Estonia Latvia UK-based Veterinary Medicine Directorate

Accession Procedure

Useful documents –

Guidelines for accession to PIC/S, Application form, Questionnaire on National Inspection Systems

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

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

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

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

PIC/S On Line

PIC/S Web site launched on 12 May 2000

http: //www.picscheme.org

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

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

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.

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

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 )