When handling a pharmaceutical or medical device, it is imperative in the eyes of the regulator, such as the TGA or FDA, that people within your organisation are assigned appropriate roles and responsibilities. One of the most important roles is that of the Authorised Person, who is responsible for authorising steps of the manufacturing process, or providing the final signature before product is released to the market. In this space, TGA Guidance on Release for Supply for Medicinal Product Manufacturers is relatively new.
If you’re looking to assign someone as an Authorised Person, or have such responsibilities already, it is important that you have a thorough understanding of:
- Batch review and decision making on disposition; including deviation evaluation and close-out
- GMP Agreements and auditing in contract giving and acceptance
- Process Control Plans and Quality System processes (including risk assessment tools)
- Stability and validation status of product being released
Having an understanding of these areas will ensure that your Authorised Persons lower the risk of unsafe products being released to the market.
Contact us if you’d like assistance with understanding the roles and responsibilities of an Authorised Person and the impact they have on your organisation. Or you may want be interested in our Release for Supply training program.
