안녕하세요.

GMPSchool입니다.

2017년 1월 1일부터 개정된 PIC/S 의 의약품에 대한 가이드가 발효되었습니다.

Chapter 1  “Pharmaceutical Quality Systems”
Chapter 2  "Personnel"
Chapter 6  "Quality Control"
Chapter 7  "Outsources Activities"

위의 4개 Chapter가 변경되었으며 자세한 내용은 하단의 내용을 참조하시기 바랍니다.

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

On 1st of January 2017, revision 13 of the PIC/S Code of GMP for medicinal products (PIC/S PE 009-13) entered into force. Four Chapters  of PIC/S PE 009-13 were revised to align with the current EU GMP code and ICH Q10. This was conducted “with some minor differences in terms of language“. The PIC/S website indicates that the PIC/S PE 009-13 revision was managed by the PIC/S Sub-Committee on the Harmonisation of GM(D)P, led by Paul Gustafson (Canada/RORB).

What are the main changes?

The title of Chapter 1  of PIC/S PE 009-13 has now been changed to “Pharmaceutical Quality Systems” and the title of Chapter 7 has now become “Outsources Activities”. These two Chapters, along with Chapter 2 Personnel have been revised to reflect the current version of ICH Q10 and the lifecycle stages.

Chapter 2 Personnel has a new section on consultants that states: “Consultants should have adequate education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records should be maintained stating the name, address, qualifications, and type of service provided by these consultants.”

In Chapter 6 Quality Control, “all sections have been reviewed and amended“. A new section on “Technical transfer of testing methods” for analytical methods has been added.

The scope of Chapter 7 Outsources Activities has been expanded and not just focused on contract manufacture and analysis.

As discussed in a 2016 blog titled Outdated Australian GMPs – Should we be doing more to protect our “brand Australia”?, the gap between PIC/S PE 009-13 and the version adopted by the TGA (PIC/S PE009-8) continues to widen. The blog stated that there is an inevitability around the TGA moving to a more current version of PIC/S. After all, this is what being part of the international harmonised community is about.

But, is it time for Australia to ‘bite the bullet’ and align with current PIC/S PE009 to ensure we stay harmonised with the international standards?

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출처 : https://www.pharmout.net/