Australian Regulatory Audits for Good Manufacturing Practices (GMP) in pharmaceuticals are done by Therapeutic Goods Administration, Australia. They perform an audit of the pharmaceutical companies who want to export the pharmaceutical products in Australia.
After performing audits they provide the list of non-compliance. Companies provide the CAPA for that non-compliance to satisfy the auditors.
After performing audits they provide the list of non-compliance. Companies provide the CAPA for that non-compliance to satisfy the auditors.
- Australian code of GMP for human blood and tissues
- Australian code of good manufacturing practice for medicinal products
- Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 & 8
- Guide to interpretation of the Code of GMP for the manufacture of 18-Fludeoxyglucose injections
- Guideline for the preparation of Technical Master Files for blood, blood components and haematopoietic progenitor cells
- Guidelines for sterility testing of therapeutic goods
- PIC/S explanatory notes for pharmaceutical manufacturers on the preparation of a site master file
- PIC/S guide for good manufacturing practice for medicinal products
- What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs
- A to Z TGA
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