TGA Internet site archive
The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application.
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