06.08.2004

New Q-and-A Website on cGMP by FDA

GMP News No. 447

GMP News
6 August 2004

New Q-and-A Website on cGMP by FDA

Within the framework of FDA's cGMP Initiative, the Center for Drug Evaluation and Research (CDER) has opened up a new questions-and-answers (Q-and-A) section on its website. It is meant to help render FDA's current cGMP interpretation more transparent. These questions and answers are classified by CDER as high as Level 2 guidance, and the section is run jointly by CDER, CBER, CVM, and ORA.

The questions and answers that have now been published deal with many aspects of chapter 21 CFR 211 "Current Good Manufacturing Practice for Finished Pharmaceuticals." They cover the following topics:

Organisation and Personnel
Buildings and Facilities

Equipment

Control of Components and Drug Product Containers and Closures

Production and Process Controls

Packaging and Labeling Control

Holding and Distribution

Laboratory Controls

Records and Reports

Returned and Salvaged Drug Products

Under "equipment" you will find e.g. the question whether built-in auto-calibration features of analytical balances fully replace external performance checks. Regarding "production and process controls" there is a discussion about non-obvious sources of contamination that can cause a positive media fill result.

Another interesting question in the field of "records and reports" is: May an internal audit report be destroyed after the corrective measures have been carried out?

Moreover, the individual answers list useful literature- and cross references. They also include the name and e-mail address of the author, who can be contacted for further information!

In this way, a number of questions and answers have already been compiled on these CDER web pages.

Unfortunately, the introduction does not explain where the questions come from and in which intervals new questions are added. This section will certainly establish itself as an important source of information for all those who work in a GMP-regulated environment.

You will find the Q-and-A website at:
http://www.fda.gov/cder/guidance/cGMPs/default.htm.

If you are looking for interpretations of FDA's cGMP requirements on the above topics, we recommend you:

Equipment	FDA/GMP-Compliant Qualification and Validation in Sterile Production in Berlin, Germany, on 18-19 October 2004
Control of Components and Drug Product Containers and Closures	FDA and EU GMP Compliance in Quality Assurance Units in Milan, Italy, on 6-8 October 2004
Production and Process Controls	Microbiological Facility Control in Berlin, Germany, on 5-7 October 2004 Process Simulation/Media Fill in Barcelona, Spain, on 16-17 November 2004
Packaging and Labeling Control	FDA/GMP Compliant Extractables and Leachables in Berlin, Germany, on 2-3 December 2004
Laboratory Controls	FDA Compliance in Analytical Laboratories in Madrid, Spain, on 10-12 November 2004
Records and Reports	GMP/FDA-Compliant Batch Record Review in Frankfurt/Main, Germany, on 14-15 October 2004 FDA/EU Requirements for Lab Computers and Records in Barcelona, Spain, on 27-29 October 2004

Author:
Dr Ulrich Herber
CONCEPT HEIDELBERG

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