Making sure your products meet current standards

Product Specifications

The ‘finished product specifications’ set out the criteria your product must meet must meet at release (the ‘release specifications’) and the criteria your product must meet if it is tested at any time during its shelf life (the ‘expiry specifications’).

If your product was ‘grandfathered’ or registered some time ago, the specifications may not reflect current requirements – including those in the current British or US Pharmacopeia and in regulatory guidelines for prescription, OTC or complementary medicines.

We can help by reviewing your existing technical documentation including product specifications and advising on the action you need to take to bring them up to contemporary standards.