Benefits of PIC/S Membership for the Philippines

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Benefits of PIC/SMembership for the Philippines
Bob Tribe Former Chairman of PIC/S
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Overview

• Role functions of PIC/S (Pharmaceutical
  Inspection Co-operation Scheme)
• PIC/S Members
• Benefits of PIC/S membership for the Philippines
• PIC/S Accession Procedure
• PIC/S GMP Guide
• Training for PIC/S Inspectors

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PIC/S Goal

• To lead the international development,
  implementation and maintenance of harmonised GMP
  standards and quality systems of inspectorates in
  the field of medicinal products.

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Achievement of the Goal

• PIC/S Goal is achieved by
• Developing and promoting harmonised GMP
  standards and guidance documents.
• Training GMP inspectors of competent authorities.
• Assessing (and reassessing) GMP Inspectorates.
• Facilitating the co-operation and networking for
  competent authorities and international
  organisations.

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Main features of PIC/S

• Commenced operating in November 1995.
• Previously existed as PIC (Pharmaceutical
  Inspection Convention) from Oct 1970 to Nov95.
• Is a Cooperative Arrangement between GMP
  regulatory authorities ie. not a legal treaty.
• A forum for
• networking and confidence building
• Exchange of information and experience on GMP
• Focus on Quality Systems for Inspectorates
• Focus on training of GMP inspectors
• International harmonisation of GMP
• No obligation for member authorities to accept
  inspection reports of other members.

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Austria Belgium Czech Rep. Denmark Estonia
Finland France Germany Greece Hungary
Iceland Ireland Italy Latvia Liechtenst.
Lithuania Malta Netherlands Norway
Poland Portugal Romania Slovak Rep.
Spain Sweden Switzerland UK
37 PIC/S Members (at 1 January 2010)
Canada
Cyprus
Israel
Malaysia
Singapore
Australia
South Africa
Argentina
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How PIC/S Operates

• Secretariat (Geneva based)
• Executive Bureau (Chairman, two Deputy Chairmen,
  four Members of PIC/S Committee)
• PIC/S Committee (usually the Chief Inspector of
  each Agency)
• Small Budget (members pay annual membership fee)
• Good relationships and collaboration (family
  atmosphere)
• Training opportunities (eg. Seminars, Joint
  visits, coached inspections)
• Information exchange (eg. inspection reports,
  Rapid Alerts)
• Development of GMP Guides guidance documents

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Benefits of PIC/S Membership

• For Regulatory Authorities
• Accession forces improvements ie. Discipline.
• Cost savings more effective use of resources.
• Inspector training (Seminars, Joint Inspections,
  coached inspections).
• Involvement in developing international GMPs.
• Promotion of harmonisation of GMP inspections.
• Sharing of information experiences.
• Networking personal contacts.

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Benefits of PIC/S Membership

• For Industry
• Improved consumer protection confidence.
• Reduced duplication of inspections.
• Cost savings.
• Export facilitation.
• Enhanced market access.
• Reputation of industry enhanced.
• Transparent inspection standards.
• Consistency of inspections.

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Growth in Australian Exports resulting from
PIC/S membership
PIC/S Membership
Source The Australian Pharmaceutical Industry
and its Global Context, Working Paper No. 7,
September 2002. Mr George
Messinis, Centre for Strategic Economic Studies,
Victoria University of Technology, Melbourne
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Benefits of PIC/S Membership

• For Patients Consumers
• Increased confidence in the quality of medicines
  supplied in the Philippines.
• More reliable consistent quality of medicines.
• Improved patient consumer safety protection.
• Better control of counterfieted medicines.
• Improved access to affordable quality medicines.

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Applicants currently being assessed for PIC/S
membership
The GMP Regulatory Authorities of

• Iran
• Ukraine
• Slovenia
• US FDA

• Thailand
• Indonesia
• Philippines

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Agencies showing an interest in joining PIC/S
The GMP Regulatory Authorities of

• Taiwan
• Brazil
• Bulgaria
• Croatia
• PR of China

• Japan
• Saudi Arabia
• South Korea
• NZ
• Hong Kong

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PIC/S Accession Procedure

• Steps to Accession
• General interest commitment, eg. attend
  Seminars.
• Written application to Secretary supporting
  documents (Philippines send application in June
  2009).
• PIC/S Committee appoints Rapporteur to evaluate.
• Applicant invited to Committee meeting to answer
  questions of Rapporteur and Committee.
• PIC/S delegation undertakes assessment
  visit(assesses Inspectorates procedures
  Quality System, observe 3 or 4 inspections).
• Delegation report issued (to applicant
  Committee).
• Committee decides on membership.

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PIC/S GMP Guide

• PIC/S GMP Guide to GMP for Medicinal Products
  (PIC/S document PE 009-9, 1 September 2009).
• Virtually identical to EC GMP Guide
• (main difference Qualified Person vs
  authorised person).
• Divided into 3 parts
• Part I PIC/S GMP Guide (general provisions).
• Part II GMP Guide for APIs (identical to ICH
  Q7A).
• Annexes 1 to 20.

(PIC/S GMP Guide available at www.picscheme.org)
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PIC/S GMP Guide(PE 009-9, 1 September 2009)

• Introduction
• Chapter 1 Quality Management
• Chapter 2 Personnel
• Chapter 3 Premises Equipment
• Chapter 4 Documentation
• Chapter 5 Production
• Chapter 6 Quality Control
• Chapter 7 Contract Manufacture Analysis
• Chapter 8 Complaints Product Recall
• Chapter 9 Self Inspection

(PIC/S GMP Guide available at www.picscheme.org)
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PIC/S GMP GuideAnnexes

1. Sterile Medicinal Products
2. Biological Products for Human use
3. Radiopharmaceuticals
4. Veterinary medicinal products other than
   immunologicals
5. Immunological veterinary medicinal products
6. Medicinal gases
7. Herbal medicinal products
8. Sampling of starting and packaging materials

(PIC/S GMP Guide available at www.picscheme.org)
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PIC/S GMP GuideAnnexes

• Liquids, creams ointments
• Pressurized metered dose aerosol products
• Computerised systems
• Ionising radiation
• Investigational medicinal products
• Products derived from human blood or human plasma
• Qualification and validation
• Qualified person and batch release
• Parametric release
• Reference and retention samples
• Quality Risk Management (voluntary)(identical to
  ICH Q9)

(PIC/S GMP Guide available at www.picscheme.org)
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Recent Changes

• Changes to the PIC/S GMP Guide since 2006
• Product Quality Review (cl. 1.4).
• Quality Risk Management (cl. 1.5, 1.6 new
  Annex 20).
• On-going Stability Program (cl. 6.23 - 6.33).
• Counterfeiting (cl. 8.7- 8.8).
• Significant changes to Annex 1 (Sterile Medicinal
  Products).
• New Annex 19 on Reference Samples Retention
  Samples.
• New Annex 20 on Quality Risk Management.
• Many of these discussed on PharmOuts GMP
  Validation Blog at
• http//www.pharmout.com.au/blog/

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Useful PIC/S Aide Memoires

• Whilst PIC/S Aide Memoires are written for GMP
  inspectors, they can be very useful for a
  companys internal audits.
• Aide Memoire on Inspection of Utilities Sept07
• Aide Memoire on Inspection of Packaging Jan09
• Aide Memoire on Inspection of QC
  Laboratories Sept07
• Aide Memoire on Inspection of APIs Jan09
• Aide Memoire on Inspection of Biotech Sept07
• Aide Memoire on Medicinal Gases Sept07

(All available at www.picscheme.org)
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Useful PIC/S Guidance Documents

• Good Practices for Computerised Systems Sept07
• Validation (Master Plan, IQ, OQ, Process
  Cleaning) Sept07
• Site Master File Preparation (Explanatory
  Notes) Sept07
• Guidance on Parametric Release Sept07
• Recommendations on Sterility Testing Sept07
• Isolators for Aseptic Processing and Sterility
  Testing Sept07
• Validation of Aseptic Processing June09

(All available at www.picscheme.org)
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PIC/S Training for GMP Inspectors

• Training Seminars
• Joint Visits Groups
• Coached inspections
• Expert Circle meetings

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Recent PIC/S Training Seminars

• Biotechnology France, 2000
• Inspection of Utilities Czech Rep,
  2001
• Interface between GCP and GMP Canada, 2002
• Inspection of QC laboratories Slovak Rep, 2003
• Inspection of APIs Spain, 2004
• Packaging/Labelling/Prevention of
  Mix-ups Romania, 2005
• Risk Management Germany, 2006
• Inspection of Solid Dosage Forms Singapore,
  2007
• Inspection of GDP Poland, 2008
• Sterile Aseptic Manufacturing Sweden, 2009
• 120 participants from 40 different countries
• (Booklets/CDs of Seminar proceedings available
  for purchase)

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Representatives from Indonesia and Turkey
participating in the PIC Seminar on Computer
Systems, Sydney, September 1996
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Future PIC/S Seminars

• Inspection of Traditional Medicines Malaysia,
  2010
• Good Inspection Practices South Africa, 2011
• (NB Open to GMP inspectors only, including
  inspectors from non-PIC/S countries)

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PIC/S Joint Visits

• Started in 1987.
• About 30 groups, with each group comprising 3
  inspectors from 3 different countries.
• 1 inspection per year per country.
• Benefits
• for training purposes
• for uniform GMP interpretation
• for uniform inspection procedures
• for mutual confidence

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Coached Inspections

• New initiative by PIC/S.
• Started in September 2009.
• 6 applicants to date all inexperienced
  inspectors.

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Expert Circle Groups

• Human Blood and Tissues
• Hospital Pharmacy
• Computerized systems
• APIs
• Quality Risk Management
• Aim - Develop draft guidance documents
• - Training in specialized field

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PIC/S Relationship with EMEA

• EMEA representative attends PIC/S Committee
  meetings as an observer
• PIC/S-EU liaison officer attends EU Inspectors
  meetings at EMEA as an observer
• A harmonised consultation procedure
• EU PIC/S usually adopt each others GMP Guides
  guidance documents
• An Associated Partnership in place

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Liaison with other organisations

• WHO Co-operation with PQ (Prequalification of
  Medicines) and IVB (Immunization, Vaccines and
  Biologicals)
• EDQM (The European Department for the Quality of
  Medicines) An Associated Partnership in place
• ICH (participation in the development of ICH
  Guidelines)
• UNICEF - An Associated Partnership in place
• European Commission (DG SANCO, DG Enterprise)

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PIC/S Executive Bureau (2010)

• PIC/S Executive Bureau
• Chairman T Gråberg (MPA, Sweden)
• 1st Dep. Chairman H Baião (INFARMED, Portugal)
• 2nd Dep. Chairman J Gouws (MCC, South Africa)
• Member V Revithi (EOF, Greece)
• Member P Hargreaves (MHRA, UK)
• Member M Boon (HSA, Singapore)
• Member J Holy (ISCVBM, Czech Republic)

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www.picscheme.org
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PIC/S contact details

• PIC/S Secretariat
• 14, Rue du Roveray
• CH - 1207 Geneva
• Switzerland
• Tel [phone]
• Fax [phone]
• Email info_at_picscheme.org
• Web site www.picscheme.org