Worldwide harmonized GMP for active pharmaceutical ingredients published as "Consensus Draft Guideline"

GMP-News Nr. 65

3 August 2000

Worldwide harmonized GMP for active pharmaceutical ingredients published as "Consensus Draft Guideline"


The official publication of the draft GMP for active pharmaceutical ingredients from working group ICH Q7A has been long awaited. 

Now it's here, the “Draft Consensus Guideline – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (APIs)”. This draft was published for consultations on July 19, 2000 as Step 2 of the ICH process. 

Now what does this all mean? 

First of all this means that the European Union, Japan and the USA (FDA) have agreed on a common Draft Guide. What is more, owing to the World Health Organization's observer status, the Pharmaceutical Inspection Convention Scheme (PIC/S) and, inter alia, China, India and Australia, a worldwide harmonization has been achieved. 

Although this Guide still has draft status, it is expected that only minor changes will be made until the final document is published. 

The publication signifies the codification of the state of the art in the case of GMP for active pharmaceutical ingredients.  

The document answers the following questions:

  • When does API manufacturing begin?

  • What are the requirements as regards rooms and equipment?

  • What documents are necessary for production, storage and quality control?

  • What requirements are to be placed on validation and change control?

  • What is to be observed during reworking and reprocessing?

Chapters 16, 17, 18 and 19 concern the special regulations, which include:

  • Contract manufacture of APIs

  • Requirements as regards agents, brokers, distributors, repackers and relabelers

  • Specific guidance for APIs manufactured by cell culture / fermentation

  • APIs for use in clinical trials

This year the European GMP Conference for Active Pharmaceutical Ingredients is taking place for the third time. The conference, which was held in Brussels in the two previous years, is organized by APIC, a sector committee of the European Chemical Industry Council (CEFIC). The conference will take place in Hamburg on September 6 -8, 2000. 

Click here to read the program.

Click here to load the ICH Guide!



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