Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
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