Geneva, 18 July 2011: Scrip, World Pharmaceutical News, titles FDA's Hamburg declares no one can "inspect world on its own" in an article relating to PIC/S 40th anniversary. The article (© Scrip, Elizabeth Sukkar) can be downloaded from the link below.

Geneva, 9 June 2011: A second, more detailed press release has just been issued on the PIC/S Committee meeting and 40th Anniversary Symposium, which took place in Geneva (Switzerland) on 30-31 May 2011. The press release can be downloaded from the link below.

Geneva, 8 June 2011: Dr. Margaret Hamburg, US FDA Commissioner, delivered a key note address at PIC/S' 40th Anniversary Symposium in Geneva (Switzerland) on 31 May 2011. The speech can be downloaded from the link below (click on "document"). Other speeches by Dr. Hamburg are also available on the FDA's web site at the following link: http://www.fda.gov/NewsEvents/Speeches/default.htm

Geneva, 1 March 2012: The Parenteral Drug Association (PDA) Europe will be holding in co-operation with PIC/S a Workshop on 9-10 May 2012 in Geneva Switzerland.

The workshop will be on GMP Inspection Practices and Trends and will bring together inspectors and industry sharing experiences gained in GMP inspection.

Geneva, 6 June 2011: The PIC/S 40th anniversary took place on 31 May 2011 in Geneva (Switzerland).

The press release regarding this event can be downloaded from the link below:

Geneva, 6 June 2011: The Pharmaceutical Inspection Co-operation Scheme (PIC/S) celebrated its 40th anniversary at a landmark symposium dedicated to “40 Years of Co-operation & Mutual Confidence: Challenges & Future Perspectives” held in Geneva on 31 May 2011.

Many Heads of Agencies attended the event including Dr. Margaret Hamburg, US FDA Commissioner, who delivered at this occasion a keynote address on “The importance of PIC/S in our globalized world” and called upon all Regulatory Authorities to co-operate more closely and share information on GMP inspections, in particular in third countries

The objectives of the symposium were to celebrate 40 years of PIC/S as well as promote and highlight PIC/S contributions to international issues. The symposium was opened by Mr. Tor Gråberg, PIC/S Chairman, and was divided into three sessions, (i) Key considerations for becoming a PIC/S Participating Authority; (ii) Management of risk; (iii) Challenges ahead and the future of PIC/S.

The symposium was attended by more than 160 participants from more than 50 countries including Competent Authorities from all continents, demonstrating that from a purely European organisation, created back in 1971, it has now become truly global. All PIC/S partners: EMA, EDQM, UNICEF and WHO were equally present as well as professional and industry associations such as APIC, EFPIA, ISPE, IFPMA, PDA. 

Geneva, 18 November 2011: the PIC/S Committee met on 7-8 November 2011 in Cape Town (South Africa).

The meeting was followed by the PIC/S annual training seminar on 9-11 November. The topic of the seminar was "Good Pharmaceutical Inspection Practices".

The press release regarding these events can be downloaded from the link below: 

(Geneva, 18 February 2011). On 28 December 2010, PIC/S and EMA (the European Medicines Agency) signed a new cooperation agreement by which they have agreed to strengthen their co-operation in the field of Good Manufacturing and Distribution Practice (GMDP) in areas of common interest with a view to the sharing of resources and avoidance of duplication of activities.

The cooperation will focus on the training of inspectors in the field of GMDP as well as include mutual participation to each other’s meetings, exchange of information and cooperation in the auditing of GMP inspectorates.

The Cooperation Agreement can be downloaded from the EMA website : http://www.ema.europa.eu  under Partners & networks / International Organisations / PIC/S

Geneva, 17 April 2012: On 10 April 2012, the Korea Food and Drug Administration (KFDA) applied for PIC/S membership. The Rapporteurs will be appointed at the next PIC/S Committee Meeting on 7-8 May 2012 in Geneva.

Geneva, 15 February 2011: At its meeting in Kuala Lumpur (8-9 November 2010), the PIC/S Committee has adopted the revision of the Explanatory Notes for Industry on the Preparation of a Site Master File (PE 008-4).  The main purposes of the revision are the simplification of the document and the implementation of requirements in relation with quality risk management.

The revised document enters into force on 1 January 2011.  On 15 February, the PIC/S Secretariat added a footnote into the revised SMF without formally amending the document.  The footnote indicates that a D-U-N-S reference is required for Site Master Files submitted to EU/EEA authorities for manufacturing sites located outside of the EU/EEA. 

The SMF will become compulsory in the EU/EEA upon the entry into force of the revised Chapter 4 of the EU GMP Guide (the SMF will be included in Part 3 of the EU/EEA GMP Guide).  The Commission has published the EU/EEA SMF on its website. 

The PIC/S SMF can be downloaded from the link below:

Geneva,2 April 2012: The PIC/S Committee has adopted an Aide-Memoire on Assessment of Quality Risk Management Implementation(PI 038-1), which will enter into force on 2 April 2012.

The Aide-Memoire has been developed by the PIC/S Expert Circle on Quality Risk Management. The purpose of the document is to assist GMP inspectors in the assessment of QRM implementation in industry during regulatory inspections. Parts of the Aide-Memoire may also be useful (with suitable modification) during other GXP inspections where similiar principals of QRM also apply.

This Aide-Memoire should also contribute to a harmonised approach for inspection of QRM in industry between the different PIC/S Participating Authorities.

The document can be downloaded from the link below:

On 1 January 2011 the US Food and Drug Administration (FDA) and the Ukraine’s State Inspectorate for Quality Control of Medicines (SIQCM) will officially become the 38th and 39th Particicpating Authorities of the Pharmaceutical Inspection Co-operation Scheme, repsectively.

Geneva, 16 January 2012: the revised PIC/S Scheme which was formally adopted at the PIC/S Committee Meeting in Cape Town on 7-8 November 2011 entered into force on 1 January 2012.

The Scheme was revised in order to reflect several novelties concerning in particular the inclusion of a reference to Good Distribution Practices (GDP), the new PIC/S pre-accession process, structural changes as well as the better sharing of information and of confidentiality.

The revised PIC/S Scheme (PICS 01 95 (Rev 5)) can be downloaded from the link below:

Geneva, 26 March 2012: On 9 March 2012 Japan's Ministry of Health, Labour and Welfare (MHLW) applied in its name as well as on behalf of the Pharmaceuticals and Medical Devices Agency (PMDA) and the Japanese Prefectures for PIC/S membership.The Rapporteurs will be appointed at the next PIC/S Committee Meeting on 7-8 May 2012 in Geneva.

The PIC/S Committee met on 8-9 November 2010 in Kuala Lumpur (Malaysia).

The meeting was followed by the PIC/S annual training seminar on 10-12 November. The topic of the seminar was the "GMP inspection of manufacturers of traditional / herbal medicinal products".

In the margins of the Seminar, a PIC/S - ASEAN forum also took place on 12 November in the afternoon.

The press release regarding these events can be downloaded from the link below:

Geneva, 16 February 2012: The PIC/S Expert Circle on Quality Risk Management has developed a Recommended Model for Risk-Based Planning in the GMP Environment (PI 037-1).

This PIC/S Recommendation sets out a simple and flexible Quality Risk Management tool that may be used by Inspectorates when planning the frequency and scope of GMP. It is a methodology that is based upon the concept of rating manufacturing sites on the basis of an estimated risk that they may pose to patients, consumers, animals and users of medicines. The methodology also takes into account the risk to product quality.

This document was adopted by the PIC/S Committee on 19 December 2011 and entered into force on 1 January 2012.

The document can be downloaded from the link below:

On 9-12 August 2010, a reduced PIC/S Audit Team conducted a follow-up (FUP) on-site visit at the FDA Headquarters in silver Spring (Maryland) in order to verify a number of issues noted during the August 2009 PIC/S on-site assessment visit.

Following this FUP visit, the PIC/S audit team concluded that most outstanding issues had been addressed by US FDA or that the appropriate actions will be taken to address them in the near future.

As a next step, the PIC/S Audit Team will present its conclusions to the PIC/S Committee in Kuala Lumpur (Malaysia) on 8-9 November 2010 and recommend to the Committee to accept the accession of US FDA to PIC/S as from 2011.

A US FDA delegation will participate in the Committee meeting and report on the on going implementation since the FUP visit. 

Additional reading on this topic is available in the article below: 

Registration for the 2010 Seminar on the "Inspection of Manufacturers of Traditional / Herbal Medicinal Products" (Kuala Lumpur, 10-12 November 2010) is now open on the seminar's website

Geneva (22 June 2010): Recently, PIC/S has been invited by the European Commission to participate in an initiative for enhanced international co-operation in the field of APIs. PIC/S believes that the proposal is a recognition of its important role in the field of APIs, in particular with regard to: 

• the assessment of Competent Authorities;
• training (through the PIC/S Expert Circle on APIs) and;
• sharing of information related to APIs inspections.

On 22 June 2010, the PIC/S Chairman sent a positive response to the Commission regarding PIC/S’ involvement.

In relation with the Commission’s proposal, the PIC/S Expert Circle on APIs has started developing, in co-operation with other partners (e.g. EDQM, EMA, ICH, US FDA, WHO, etc.), an international training for inspectors on APIs.  The training will focus on i) an introduction to ICH Q7 (basic course) and ii) on how to inspect APIs (advanced course).

Geneva (16 June 2010): The PIC/S Secretariat has received the following membership applications in the past three months:

- 14 June 2010: Taiwan Food and Drug Administration (TFDA)

- 7 June 2010: Veterinary Medicines Directorate (VMD) 

- 16 April 2010: Medicines and Medical Devices Safety Authority (Medsafe)

With the application of TFDA and Medsafe, five Australasian Competent Authorities are currently assessed for joining PIC/S. Other applications are expected from this very dynamic region. Recently, the Hong Kong Pharmacy and Poison Board also announced its intention to apply for PIC/S membership in the near future (see news below).

VMD, located in Surray (UK), is the third veterinary authority to apply for PIC/S membership (after the Czech Institute for State Control of Veterinary Biologicals and Medicines [ISCVBM] and the French Agency for Veterinary Medicinal Products [ANMV] - both being PIC/S Participating Authorities). The competent authority for the inspection of medicinal products for human use in the UK, the MHRA, is a founding member of PIC/S.

According to PIC/S rules, several Competent Authorities from the same country can apply for membership. The PIC Scheme is an arrangement between national drug regulatory authorities - not between States.

Geneva (19-20 May 2010) The 31st meeting of the PIC/S Committee took place in Geneva (Switzerland) on 19-20 May 2010.

The meeting was preceded by a meeting of the PIC/S Executive Bureau on 17 May and a meeting of the Sub-Committee on Training on 18 May. 

To read the press release, click on the link below.

Geneva (20 May 2010): The PIC/S Committee has endorsed a Memorandum of Understanding (MoU) between PIC/S and the Russian Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor) with a view to encourage the latter’s application for PIC/S membership.

Geneva (19-20 May 2010): A delegation form US FDA participated in the last meeting of the PIC/S Committee meeting.

Following discussions with the delegation the Committee decided to send a reduced audit team for a follow-up visit to the USA from 9 to 13 August 2010 in order to review the outstanding issues in the assessment of US FDA’s application for PIC/S membership.

Geneva (18 May 2010): In the margin of the Committee meeting, the PIC/S Chairman together with several Executive Bureau Members met with a Delegation from Hong Kong SAR led by Dr. P. Y. Lam, Director of Hong Kong’s Department of Health.  The meeting focused on the Department of Health’s intention to submit an application for PIC/S membership.

A Memorandum of Understanding (MoU) was signed in Moscow on 12 February 2010 between the PIC/S Chairman and the Head of the Federal Service on Surveillance in Healthcare and Social Development in the Russian Federation (Roszdravnadzor).

The MoU aims at facilitating Roszdravnadzor's application for PIC/S membership (and accession to PIC/S).

The MoU will only come into effect after its formal approval by the PIC/S Committee at its next meeting in Geneva on 19-20 May.

An informal Working Group within PIC/S has developed an example of methodology for the implementation of Quality Risk Management (QRM) in industry.

This example of methodology is not intended to be issued by PIC/S as a recommendation or as a guideline for industry and / or for GMP inspectors but it could be used by PIC/S for training purposes.

Whether this example is used by industry for other purposes is of no concern to PIC/S and will not influence the outcome of PIC/S inspections.

To download the document click on the link below:

PIC/S has published a revised version of the recently adopted Recommendation for the technical interpretation of Annex 1 to the PIC/S GMP Guide, which has been prepared by Switzerland / Swissmedic.

The revised Recommendation is the outcome of recent consultations of EEA and PIC/S Competent Authorities in order to reach a common document between the EEA and PIC/S.

The Recommendation summarises the interpretations which an inspector from a national regulatory authority should adopt when performing an inspection of a manufacturer of sterile medicinal products.

The PIC/S Committee met in Uppsala (Sweden) on 2-3 November 2009.

Main highlights:

♦ Election of new Chairman and Deputy Chairpersons;

♦ Enlarged Executive Bureau to better reflect regional representation in PIC/S;

♦ US FDA application for PIC/S membership: giant leap forward;

♦ Adoption of technical interpretation or revised Annex 1 to PIC/S GMP Guide

The meeting was followed by the annual PIC/S Seminar on "Aseptic & Sterile manufacturing from APIs to finished dosage forms". The Seminar was attended by more than 100 participants from almost 50 national regulatory authorities or international organisations from all continents.

To download the Press Release click on the link below:

The revised PIC/S GMP Guide (PE 009-9) was adopted by the PIC/S Committee at its meeting in Geneva on 5-6 May 2009. The revision concerns Annex 3.

The revised PIC/S GMP Guide entered into force on 1 September 2009.

On 1 July 2009 Lithuania's State Medicines Control Agency (SMCA) became the 37th PIC/S Participating Authority.

On 1 June 2009 the Philippines' Bureau of Food and Drugs applied for PIC/S membership.

On 27 May 2009 PIC/S and the World Health Organization (WHO) signed a co-operation arrangement.  The co-operation will be implemented between PIC/S and WHO’s team on Quality Assurance and Safety and WHO’s team on Biologicals and Medicines. It will focus on the training of inspectors and on the sharing of documents.