This guidance explains TGA's interpretation and expectations for compliance by therapeutic sunscreen manufacturers, with specific sections of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE009-13 (PIC/S Guide to GMP).
TGA has adopted the PIC/S Guide to GMP, PE009-13 (excluding Annexes 4, 5 and 14), which took effect on 1 January 2018 with a 12-month transition plan.
This guidance is not mandatory or enforceable under law. It is not intended to be restrictive. It describes a way that a sunscreen manufacturer may operate to demonstrate compliance with the PIC/S Guide to GMP, PE009-13.
This information is provided for guidance only and has been developed on the basis of current knowledge of the subject matter. It should not be relied upon to address every aspect of the relevant legislation.
In this guidance, 'we' refers to the TGA and 'you' refers to manufacturers.
Related information
For technical requirements, refer to:
Other TGA guidance relevant to sunscreen manufacturing:
- Manufacturing medicines
- Data Management and Data Integrity (DMDI) Guidance
- Release for supply of medicines
- PQRs for listed and complementary medicines
- Supplier assessment, approval and qualification for listed and complementary medicines
- Process validation for listed and complementary medicines
- Medicines labels: Guidance on TGO 91 and 92
- Uniform recall procedure for therapeutic goods
Other useful guidance:
- WHO heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms (Annex5, TRS 961)
- CPMP/ICH/381/95: ICH Topic Q 2(R1) – Note for Guidance on Validation of Analytical Procedures: Text and Methodology
- PIC/S recommendation publications
Further questions
If you have further questions, or you require further clarification of a particular requirement, email the Manufacturing Quality Branch.