News

May 2017

2017 PIC/S Seminar (Chinese Taipei)

Geneva, 15 May 2017: Registrations for the 2017 PIC/S Seminar on "Quality Control Laboratories: How to inspect" (Taipei, 13-15 September 2017) are now open (for National Drug Regulatory Authorities only).

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Taiwan Food and Drug Administration, Ministry of Health and Welfare (TFDA) is honoured and proud to announce that the registration is open for the PIC/S Committee Meeting and 2017 PIC/S Seminar hosted by Chinese Taipei / TFDA in Taipei from 11-15 September 2017.

The Seminar, which will take place from 13-15 September, will be on " Quality Control Laboratories: How to Inspect " and consist in a mix of presentations and workshops.

Quality control is part of Good Manufacturing Practice for ensuring the safety, quality and efficacy of pharmaceutical products. Thus, the quality control laboratory plays an integral role in confirming the quality of medicinal products. Through the seminar, participants will be introduced to basic concepts, current and trending regulatory requirements, as well as specific quality issues which have impacted on the regulatory compliance of Quality Control Laboratories. The program will include topics related to GMP inspections on QC lab and will delve into OOS/OOT investigation, data integrity issues and aspects of test methods validation and verification in the context of technical transfer. The seminar will also be a great platform for both novice and experienced inspectors to enhance their inspection skills through knowledge sharing and discussion.

For more information: click here 

April 2017

PIC/S reaffirms its stance on proposed EU ATMP GMP Guidelines and highlights gaps relating to patient safety

Geneva, 25 April 2017: On 24 April 2017, PIC/S sent a letter in response to a reply received from the European Commission on 5 April 2017 in connection with PIC/S' stance on the proposed EU Advanced Therapy Medicinal Products (ATMP) GMP Guidelines, which will not only lower GMP standards for ATMP at the risk of patients but also lead to an internationally non harmonised approach to the implementation of GMP for ATMP.

In its latest letter, PIC/S reaffirms its position and highlights gaps relating to patient safety, while welcoming the Commission's proposal for engagement with PIC/S on its initiative and seeking clarification on the scope of co-operation proposed.

For reasons of transparency and rights of patients, this letter has been published via the link below:

March 2017

PIC/S events in Geneva, Switzerland, 8-10 February 2017

Geneva, 7 March 2017: the PIC/S Committee met on 9-10 February 2017 in Geneva (Switzerland), preceded by a meeting of the PIC/S Executive Bureau on 8-9 February 2017.

The press release regarding these meetings can be viewed here.

March 2017

PIC/S takes strong stance on European Commission's proposed stand-alone ATMP GMP Guidelines

Geneva, 2 March 2017: On 24 February 2017, PIC/S sent a letter to the European Commission regretting the complete absence of co-operation and drawing attention to the Commission’s responsibilities resulting from the development of its proposed stand-alone Advanced Therapy Medicinal Products (ATMP) GMP Guidelines, which will not only lower GMP standards for ATMP at the risk of patients but also lead to an internationally non harmonised approach to the implementation of GMP for ATMP.

For reasons of transparency, this letter has been published via the link below:

December 2016

Revision of PIC/S GMP Guide (PE 009-13)

Geneva, 22 December 2016: the following Chapters of the PIC/S GMP Guide have been revised:

  • Chapter 1 on “Quality Management” (which has become “Pharmaceutical Quality Systems”); 
  • Chapter 2 on “Personnel”;
  • Chapter 6 on “Quality Control”; 
  • Chapter 7 on “Contract Manufacture and Analysis” (which has become “Outsources Activities”).

The revised Chapters 1, 2, 6 & 7 of the PIC/S GMP Guide are based on the equivalent Chapters of the EU GMP Guide with some minor differences in terms of language. Chapters 1, 2 & 7 have been aligned to ICH Q10 and the principles of “Pharmaceutical Quality System” have been integrated. A section on consultants has been added in Chapter 2. The scope of Chapter 7 has been expanded beyond the scope of “contract manufacture and analysis”. Both Chapters 1 and 7 have been renamed to reflect the changes. In Chapter 6, all sections have been reviewed and amended and a new section on “Technical transfer of testing methods” has been added.

The revision has been successfully completed by the PIC/S Sub-Committee on the Harmonisation of GM(D)P, led by Paul Gustafson (Canada/RORB). The revised GMP Guide (PE 009-13) will enter into force on 1st January 2017. All non-EEA Participating Authorities of PIC/S (and Applicants) have been invited to transpose the revised Chapters of the PIC/S GMP Guide into their own GMP Guides.

To download the revised GMP Guide (PE 009-13), please consult the page “Publications” or click on the link below: