May 26


When keeping your facility compliant and ready for an FDA audit, its important to have as much information as possible. Below is a list of 2013-2014’s FDA PET Facility audit results.

TOP 6 Major Issues

  1. Lack of adequate out of specification (OOS) investigations
  2. Inadequate media fill validations, aseptic techniques and environmental monitoring
  3. Analytical assay methods not validated or verified for intended use
  4. Deficiencies in production and process controls
  5. Lack of QA oversight for batch releases
  6. Lack of appropriate training records

Specific Issues

Deficiencies in Media Fills

  • Media fills did not simulate production
  • Media does not come into contact with all interior surface
  • Not all production personnel participate in media fills
  • Use of an overcrowded laminar flow hood
  • Use of non-sterile disinfectants
  • Dilution of drug product in unclassified area
  • Frequency of environmental monitoring not reflecting manufacturing operation
  • Storage of bulk product vial in non-sterile bag
  • Out of limit personnel monitoring results
  • No record of aseptic area having been cleaned
  • Qualification of personnel conducting aseptic operation not documented

Deficiencies in Lab Controls

In general, a failure to:

  • Identify deviations and conduct investigations
  • review batch records for release
  • review records in a timely manner
  • reject batches with OOS result
  • maintain on-site software
  • follow established procedures
  • document handling of non-conformances
  • establish change control procedures
  • train employees
  • Failure to validate methods that deviate from USP test methods
  • Failure to qualify equipment for intended use
  • Failure to maintain and calibrate equipment
  • No audit trail for gas chromatography (GC), or high performance liquid chromatography (HPLC)
  • No safeguards to prevent deletion of raw electronic test data
  • Issues with system suitability
  • Expiry of reagent, reference standards

Deficiencies in Production

  • Master batch record does not contain complete documentation of production, sampling and testing (use of sticky notes)
  • Written procedures not specific enough
  • When errors occur no decision is made to conduct an investigation
  • Inadequate qualification of chemical synthesizer
  • Cleaning not adequate for multi-product equipment
  • When processes are changed, verification to ensureconsistency isnotperformed
  • Revalidation not done on computer based programmable logic controller (PLC)

Deficiencies in Product Release

  • OOS test results are averaged to generate passing results
  • Raw test data is not retained
  • Drugs are released that did not meet specifications
  • Releasing drug without calculating or reporting the radiochemical purity in the batch record
  • Failure to conduct all QC tests for release
  • Releasing multiple lots under conditional release

Deficiencies in Documentation

  • Failure to retain raw analytical data
  • No documentation that sterility test was conducted and the lot was released
  • Equipment maintenance log missing sufficient details


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