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
- Lack of adequate out of specification (OOS) investigations
- Inadequate media fill validations, aseptic techniques and environmental monitoring
- Analytical assay methods not validated or verified for intended use
- Deficiencies in production and process controls
- Lack of QA oversight for batch releases
- 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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