It is here reported the text of  a FDA 2006 ”warning letter”  (from the FDA “Documentation and Standard Operating Procedures for cleaning” document)  in which is clearly presented the “poor record keeping” of a pharmaceutical industry.

“Laboratory records did not always include a description and identification of the sample received for testing, the date the sample was taken, the date the sample was received for testing and the data derived from the testing. 

There was no record that the laboratory received personnel monitoring sample of one person for the redacted fills. There was no record of analysis, yet the results were reviewed as acceptable. We are concerned about the failure to effectively review records at your facility.

In addition, analyst in the redacted Microbiology Laboratory do not enter the date on which the results are read into the logbook. Your proposed corrective action appears acceptable, but again there were several logbook record keeping deficiencies noted on the previous FDA 483 document”.

Note: Q7A means the Expert Working Group of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Copies of this document are available from:

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129098.pdf

http://www.fda.gov/cder/guidance/index.htm

http://www.fda.gov/cber/guidelines.htm

- Myths and misconceptions associated with pharmaceutical microbiology
- Endotoxin detection strategies and overcoming recovery challenges
- Microbiological advances for nonsterile and sterile manufacturing
- Validation of microbiological methods and implementation of rapid methods
- Strategies for microbiological investigations
- Current regulatory perspectives and an open panel discussion with regulators

See the related events:

- 17 February 2014: Pre-Conference Workshop on Bacterial Endotoxin Testing

- 20 February 2014: Microbial Contamination Control in the Pharmaceutical Industry

- 20-21 February 2014: Rapid Microbiological Methods & the new Technical Report 33

- 20-21 February 2014: The A to Z’s of Biofilm Control, Monitoring, Validation and Excursion Investigations of Pharmaceutical Water Systems. Register Here.

pda@pda.org

- Jan. 28-29: Joint Regulators/QbD Workshop – Take part in discussions with regulators from EMA, AESGP, APIC, efpia, EGA and IFAH and way forward with QbD.

February 2014

- Feb. 18-19: Pharmaceutical Microbiology – The comprehensive scientific program will include presentations from regulatory, industry and technology representatives from around the world.

- Feb. 28: Call for Papers! We would like to invite you to submit a paper or poster abstract for presentation at the 2014 PDA Europe Conference on Pharmaceutical Freeze Drying Technology in Brussels, Belgium.