New Q-and-A Website on cGMP by FDA

GMP News No. 447

6 August 2004

NewQ-and-A Website on cGMP by FDA

Within the framework of FDA's cGMP Initiative, the
Center for Drug Evaluationand 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 cGMPinterpretation more transparent. These questions and answers areclassified by CDER as high as Level 2 guidance, and the section is runjointly by CDER, CBER, CVM, and ORA.

The questions and answers that have nowbeen published deal with many aspects of chapter 21 CFR 211 "CurrentGood Manufacturing Practice for Finished Pharmaceuticals." They coverthe following topics:

    • Organisation and Personnel
    • Buildings and Facilities
  • Equipment
  • Control of Components and Drug ProductContainers 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 finde.g. the question whether built-in auto-calibration features of analyticalbalances fully replace external performance checks. Regarding"production and process controls" there is a discussion aboutnon-obvious sources of contamination that can cause a positive media fillresult.

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

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

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

Unfortunately, theintroduction does not explain where the questions come from and in whichintervals new questions are added. This section will certainly establishitself as an important source of information for all those who work in aGMP-regulated environment. 

You will find the Q-and-A website at:

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

Dr Ulrich Herber


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