FDA's System-based Approach to Inspections as Reflected in the Warning Letters

GMP News No. 329

GMP News
21 July 2003
 

FDA's System-based Approach to Inspections
as Reflected in the Warning Letters

 
Since February 2002, the FDA has been following a new inspection approach that aims at conducting and evaluating inspections with regard to specific systems. In doing so, the Agency distinguishes between the following systems:
  • Quality System
  • Facilities and Equipment System
  • Materials System
  • Production System
  • Packaging and Labeling System
  • Laboratory Control System

The idea underlying this approach is that deficiencies in one system will affect all other systems as well.

Therefore, these systems are not congruent with the subparts B - K of 21 CFR 211.

As an example, we will have a look at the "Quality System." One can assign the following paragraphs of the CFR 211 subparts to the individual parts of the quality system:

Failure Investigations

211.22 ("Responsibilities of quality control unit")

Training / Qualification

211.25 ("Personnel qualifications")

Validation / Computer

211.68 ("Automatic, mechanical, and electronic equipment")

Rejects

211.89 / 110 ("Rejected Components, drug product containers, and closures"/ "Sampling and testing of in-process materials and drug products")

Validation / Manufacturing

211.110 ("Sampling and testing of in-process materials and drug products")

Change Control

211.100 / 160 ("Written procedures; deviations" / "Lab controls - General requirements")

Reprocessing / Rework

211.115 ("Reprocessing")

Quarantine Products

211.142 ("Warehousing procedures")

Stability Failures

211.166 ("Stability testing")

Product Reviewers

211.180 ("Records and Reports - General Requirements")

Validation / Lab. Method

211.194 (Laboratory records")

Complaint Files

211.198 ("Complaint Files")

Returns / Salvages

211.204 / 208 ("Returned drug products"/ "Drug product salvaging")

The new inspection approach is reflected by the kind and frequency of the citations in the Warning Letters issued since February 2002.

Practically all of the CFR paragraphs (except for 211.89; 211.115; 211.204; 211.208) appeared with increasing frequency in the Warning Letters issued after February 2002, reaching a peak in the second half of 2002.

This trend can be verified quite well with the example of the "Laboratory Controls" system. There was e.g. a rapid increase in the Warning Letter references to paragraph 211.165 ("Testing and release for distribution") towards the end of 2002. Batch release testing is certainly one of the most important tasks of the QC laboratory, and it is no wonder that the FDA inspectors have more and more often an especially critical look at this point within the framework of the new inspection approach.

The same is true of 211.166 ("Stability testing"), which is also more and more frequently referenced in Warning Letters.

If this hot topic is also of interest to you, we recommend you to visit the international conference on "Stability Testing" that takes place in Barcelona on 18 and 19 November 2003. Top-level speakers from industry and authority will inform you about the most important innovations in this field.

What is also in the focus of FDA inspections is the topic of computerised systems in the laboratory, above all the consequences of FDA's new Part 11 approach for the QC lab. Hear all about the current state of affairs at our GMP Education Course "FDA/EU Requirements for Laboratory Computers and Records."

The University of Heidelberg organises a conference with workshop on Process Analytical Technology (PAT) titled "NIR and FDA's PAT Initiative." An FDA official will be among the speakers.

Author:
Dr Gerhard Becker
CONCEPT HEIDELBERG
  

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK