Two Recent Warning Letters for Manufacturers of Sterile Products

GMP News No. 589

GMP News
22 August 2005
 

Two Recent Warning Letters for Manufacturers of Sterile Products

 
Many of ECA’s latest activities touched on FDA’s new initiatives (cGMP Initiative, CMC risk-based approach, new GMP Inspection programme). For example in our GMP News, dated 25 July 2005, we discussed FDA’s Pilot Risk-Ranking Model for GMP Inspections. It seems that all these approaches are more and more put into practice. Recently, FDA's CDER and CBER released Warning Letters that point out to current GMP inspection trends. Subject to both inspections were companies producing sterile and therefore high risk products. Statements in those warning letters like "You are responsible for evaluating whether each observation on the Form FDA 483 represents an isolated incident or a systemic problem" reference to FDA’s system based inspection approach.

The comparison between the stated deviations and currently offered ECA courses shows that the ECA Education Courses definitely stay ahead of time. All critical topics which are mentioned in those warning letters are covered by various ECA Education Courses. To fulfil the claim to incorporate current GMP developments into all courses offered by ECA the ECA Advisory Board members will continue to assess each course continuously. Thus, you will receive the most comprehensive and up-to-date GMP training by participating in the ECA GMP Certification Programme.

The FDA Warning Letter Report with a comprehensive evaluation of all warning letters issued during one fiscal year is created every year by CONCEPT HEIDELBERG in co-operation with the European Compliance Academy. You can read a summary of the most important deviations in FY 2004 if you click here.

The following table refers to the latest inspections findings and the corresponding ECA Education Courses which will be run in the second half of 2005.

FDA Warning Letter Excerpt

Corresponding ECA Education Course

You failed to assure that your drug product meets the applicable standards of identity,

strength, quality, purity, and potency at the time of use by appropriate stability testing [21

CFR 211 .137(a), 211 .166, 680.3(e), and 610.10].

Stability Testing of Drug Substances and Drug Products, 29 – 30 November 2005, Barcelona, Spain

Your firm failed to establish and follow appropriate written procedures designed to

prevent microbial contamination of drug products … and to assure that such procedures include validation of sterilization processes, [21 CFR 211 .113(b)]

Microbiological Contamination in Pharmaceutical Production, Barcelona, Spain, 20-21 October 2005

Your quality control unit failed to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated;…

Several observations were made on the FDA 483 regarding deficient investigational practices at your firm:
Some batch records did not include complete information relating to the production and control of each batch and deviation reports were not always initiated. 21 CFR 211.192
The quality control unit did not adequately review records to assure that no errors have occurred or, if errors occurred, that they were fully investigated.

GMP/FDA-compliant Batch Record Review, Vienna, Austria, 6-7 October 2005

Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions [21 CFR 211 .42(c)(1 0)(v) and 600.11(a)].

Complying with the new FDA Aseptic Guide, Berlin, Germany, 29-30 September 2005

Your firm failed to establish an adequate system for monitoring environmental conditions of aseptic processing areas [21 CFR 211 .42(c)(10)(iv)].

Complying with the new FDA Aseptic Guide, Berlin, Germany, 29-30 September 2005

Your firm failed to establish the control systems necessary for aseptic processing operations to prevent contamination [21 CFR 211.42(c)(10) and 600.11(a)].

Complying with the new FDA Aseptic Guide, Berlin, Germany, 29-30 September 2005

You are responsible for evaluating whether each observation on the Form FDA 483 represents an isolated incident or a systemic problem.
A template, which gives the same investigation procedures and corrective actions, is not an adequate investigation.

FDA’s New Quality Systems and Risk Approach, Barcelona, Spain, 10-11 November 2005

Please address leachables in both normal and discolored containers in the study promised in your response.

GMP/FDA-compliant Extractables and Leachables Testing, Vienna, Austria, 29-30 September 2005

Sterility complaint investigation reports failed to identify and discuss any possible correlation of the sterility test isolate with microorganisms found in your firm’s environmental and personal monitoring. 21 CFR 211.198

Microbiological Challenges for GMP/FDA Compliance – Masterclass, Berlin, Germany, 23-25 November 2005

You will find all warning letters related to cGMP compliance in our public database. Please visit www.gmp-compliance.org. Enter a keyword below the top menu (e.g. validation, OOS) and you will be shown the warning letters with deviations regarding the keyword.

Author: Dr Ulrich Herber on behalf of ECA

  

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