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Technical review of product specificationsThe finished product specifications specify the criteria for release for sale of a manufactured product (the ‘release specifications’) and the criteria the product must meet if tested at any time during its shelf life (the ‘expiry specifications’).For products that were ‘grandfathered’ or registered some time ago the product specifications may not reflect current requirements including those in the current British Pharmacopoeia 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. Contact Us for more information. |
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Archer Emery & Associates is a member of the Australian Self-Medication Industry Inc |