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Guidance on licensing/certification inspections

Version 1.0, April 2013

29 April 2013

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Appendix 3: Examples of devices inspection nonconformities

Examples of major nonconformities include the following:

  • Lack of validation of critical processes (sterilization validation for example)
  • Evidence of gross pest infestation
  • Falsification or misrepresentation of quality test results
  • No or grossly inadequate air filtration to minimise airborne contaminants (where appropriate)
  • Cleaning program not followed and evidence of dirty premises/equipment or un-validated cleaning procedures (maybe critical if resulting contamination is a safety concern)
  • No stability program or equivalent to support the life of the product, where applicable. (For example, drug/device combinations)
  • Damage (holes, cracks, peeling paint) to walls/ceilings in manufacturing areas where product is exposed.
  • Design of manufacturing area that does not permit effective cleaning
  • Insufficient manufacturing space that could lead mix-ups (in particular with regards to segregation of sterilised and non-sterilised devices)
  • No raw material sampling area (could be other if adequate precautions are taken)
  • Sanitary fittings not used on liquid/cream manufacturing equipment
  • Stored equipment not protected from contamination
  • Individuals in charge of QC/Production not qualified by education, training and experience
  • Inadequate initial and ongoing training and/or no training records
  • Cleaning procedures not documented and/or no cleaning records
  • Production equipment cleaning procedures not validated
  • Reduced QC testing of raw materials without data to certify suppliers
  • Incomplete testing of raw materials
  • Test methods not validated
  • Unapproved/undocumented changes to master batch documents
  • Deviations from instructions not approved
  • No or inadequate internal audit program
  • No proper release for supply procedure
  • Product reworked without proper approval
  • No system/procedures for handling complaints or returned goods
  • Inadequate testing of packaging materials
  • Insufficient lighting in production or inspection areas
  • Temporary devices used for equipment repair
  • Containers from which samples have been taken not identified
  • Equipment not properly maintained

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