pics gmp history (file)

The system of standards intended to ensure high standards of quality assurance in the development, manufacture, and control of medicinal products.

Good Manufacturing Practice (GMP)

The organization/scheme responsible for the PIC/S GMP Guide.

Pharmaceutical Inspection Co-operation Scheme (PIC/S)

The guide that contains standards for the manufacture of medicinal products and its Annexes.

Guide to Good Manufacturing Practice for Medicinal Products

The PIC/S document number for the GMP Guide dated 25 August 2023.

PE 009-17

Products to which the GMP standards primarily apply.

Medicinal products intended for human use

Products for which the same kind of GMP attention is recommended even though the standards primarily apply to human medicines.

Veterinary products

The standards intended to serve manufacturers as a basis for developing specific rules adapted to their individual needs.

PIC/S GMP standards

Methods other than those described in the Guide that are acceptable when they can achieve the principles of the Guide.

Alternative acceptable methods

New concepts or technologies that may be used when they have been validated and provide at least equivalent quality assurance.

Validated new concepts or technologies

The section that covers GMP principles for the manufacture of medicinal products.

Part I

The section that covers GMP for active substances used as starting materials.

Part II

Sections that provide details on specific areas of manufacturing activity.

Annexes

The reference section containing terms used throughout the Guide, located after the Annexes.

General Glossary

The glossary specifically covering active pharmaceutical ingredients, located at the end of Part II.

API Glossary

The type of manufacturing process where more than one Annex may apply at the same time.

Manufacturing processes with simultaneous Annex applicability

An example of a manufacturing area for which an Annex may apply together with another Annex.

Sterile preparations

Another example of a manufacturing area that may have an Annex applied simultaneously with other Annexes.

Radiopharmaceuticals

Another manufacturing area specifically mentioned as potentially requiring simultaneous Annexes.

Biological medicinal products

The original GMP standards from which the PIC/S GMP Guide was derived.

PIC Basic Standards

The year of the original PIC Basic Standards.

1972

The organization whose GMP Guide served as the basis for the original PIC/S GMP Guide.

World Health Organization (WHO)

The international organization whose GMP Guide was the source of the original PIC/S GMP Guide.

WHO

The purpose of further developing the PIC/S GMP Guide to meet stricter manufacturing and health requirements.

To ensure high-quality medicines

The newer pharmaceutical areas specifically mentioned as being incorporated into the Guide.

Biologicals and radiopharmaceuticals

The scientific and industrial technologies specifically mentioned in the development of the Guide.

Biotechnology and parametric release

The agreement/framework under which high-quality medicines were intended to be produced.

PIC Convention and PIC Scheme

The year when the EU adopted its own GMP Guide.

1989

The GMP Guide adopted by the EU in 1989 that was equivalent in GMP requirements to the PIC/S GMP Guide.

EU GMP Guide

The way the EU and PIC/S GMP Guides have been developed since 1989.

In parallel

The relationship between the EU and PIC/S GMP Guides in terms of GMP requirements.

Practically identical

The term used in the PIC/S Guide for what the Pharmaceutical Inspection Convention calls a pharmaceutical product.

Medicinal Product

The references removed from the PIC/S Guide that are present in the EU context.

EU Directives and MRAs

The type of agreements represented by the abbreviation MRA.

Mutual Recognition Agreements

The term used by PIC/S for the person responsible for the relevant GMP function.

Authorised Person

The term used by the EU Guide instead of “Authorised Person.”

Qualified Person

The pharmacopoeia specifically mentioned in the EU context that was changed in the PIC/S Guide.

European Pharmacopoeia

The term used by the PIC/S Guide because not all participating authorities are parties to the European Pharmacopoeia Convention.

European or other relevant Pharmacopoeia

The active substances used as starting materials in medicinal product manufacture.

Active Pharmaceutical Ingredients (APIs)

The GMP guide specifically developed for active pharmaceutical ingredients.

Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

The ICH guideline adopted as the stand-alone GMP guide for APIs.

ICH Q7A

The organization that developed ICH Q7A.

International Conference on Harmonisation (ICH)

The date when the PIC/S Committee adopted the GMP Guide for APIs as a stand-alone guide.

22 May 2001

The document number initially assigned to the stand-alone API GMP Guide.

PE 007

The date when the PIC/S Committee decided to make the API Guide Part II of the current Guide.

29–30 May 2006

The part of the PIC/S GMP Guide where the API GMP Guide was incorporated.

Part II

On 21 December 2000, which Annex was revised?

Annex 14

On 21 December 2000, what happened to the Annex numbering?

All Annexes were renumbered

On 21 December 2000, what additional document feature was included?

Revision history

On 10 August 2001, which paragraph of Annex 1 was amended?

Paragraph 42

On 10 August 2001, which Annex was revised?

Annex 6

On 10 August 2001, which two new Annexes were introduced?

Annexes 15 and 17

On 10 August 2001, what happened to the glossary?

It was amended

On 15 January 2002, which two new Annexes were introduced?

Annexes 4 and 5

On 15 January 2002, what external GMP reference was added?

Annex 18 of the EC GMP Guide

On 1 September 2003, which Annex was amended?

Annex 1

What section of Annex 1 was mainly amended on 1 September 2003?

Section 3

On 1 July 2004, which Annex was revised?

Annex 13

What additional administrative change occurred on 1 July 2004?

Change in the Editor's coordinates

On 1 January 2006, which chapter was revised?

Chapter 1

On 1 June 2006, which chapter was revised?

Chapter 6

On 1 August 2006, which chapter received corrections?

Chapter 6

On 1 August 2006, which chapter was revised?

Chapter 8

On 5 April 2007, what major structural change occurred?

The Guide was reorganized into Part I, Part II, and Annexes

On 5 April 2007, what document was incorporated as Part II?

PE 007 — API Guide

What new Annex was introduced under PE 009-6?

Annex 19

What part of the Guide was revised under PE 009-6?

Introduction

On 1 September 2007, what historical section was revised?

General Introduction (“History”)

On 1 September 2007, what section related to APIs was revised?

Introduction to Part II

What was deleted from Chapter 6 and Annex 13 under PE 009-7?

Footnotes

On 15 January 2009, which chapter was revised?

Chapter 1

On 15 January 2009, which Annex was revised?

Annex 1

What new Annex was introduced under PE 009-8?

Annex 20

On 1 September 2009, which Annex was revised?

Annex 3

On 1 January 2013, which chapter was revised?

Chapter 4

On 1 January 2013, which Annexes were revised?

Annexes 6, 7, 11, and 13

On 1 March 2014, what major principle was introduced into Part II?

Quality Risk Management (QRM) principles

On 1 March 2014, which Annexes were revised?

Annexes 2 and 14

On 1 October 2015, which Annex was revised?

Annex 15

On 1 January 2017, which Part I chapters were revised?

Chapters 1, 2, 6, and 7

On 1 July 2018, which Part I chapters were revised?

Chapters 3, 5, and 8

On 1 July 2018, which Annex was revised?

Annex 17

On 1 May 2021, which Annex was revised?

Annex 2

On 26 January 2022, what happened to PE 009-16?

It was adopted by the Committee

On 1 February 2022, what happened to PE 009-16?

It entered into force

Under PE 009-16, which Annex was revised?

Annex 13

Under PE 009-16, which new Annex was introduced?

Annex 16

What is the date of PE 009-17?

25 August 2023

What was revised under PE 009-17?

Annex 1

What is the document title of PE 009-17?

Guide to Good Manufacturing Practice for Medicinal Products

Who is listed as the editor of the Guide?

PIC/S Secretariat

1972

PIC Basic Standards / WHO GMP origin

1989

EU adopted its own GMP Guide

21 December 2000

PH 1/97 (Rev.) — Annex 14 revision + Annex renumbering

10 August 2001

PH 1/97 (Rev. 2) — Annexes 15 & 17 + Annex 6 revision

22 May 2001

ICH Q7A / PE 007 API Guide adopted

15 January 2002

New Annexes 4 & 5

1 September 2003

Annex 1 amendment

1 July 2004

Annex 13 revision

1 January 2006

Chapter 1 revision

1 June 2006

Chapter 6 revision