The sections of the PIC/S Guide to GMP (PE009-13) that apply to sunscreens will be determined by the nature of your operations and the variety of products or dosage forms you manufacture.
In general, you should follow the principles of Part I of PE009-13, and in addition, all annexes relevant to their operations and dosage forms.
Generally speaking, you should meet the requirements of:
Annex 8 (sampling)
Annex 9 (manufacture of liquids, creams and ointments)
Annex 11 (computerised systems)
Annex 15 (qualification and validation)
Annex 19 (reference and retention samples)
Annex 20 (quality risk management), a voluntary annex; however, the principles outlined in the annex are applicable to the manufacture of therapeutic sunscreens
The following annexes are not usually relevant to sunscreen manufacture: annex 7 and 13.
The following annexes are not relevant to sunscreen manufacture: annexes 1, 2, 3, 6, 10, 12 and 17.
The TGA has not adopted annexes 4, 5, 14 and 16. Annex 18 no longer exists.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.