Due to the constant updates of the monographs in pharmacopoeias, it is necessary to keep the specifications (SPEC) and analytical methods (MoA) of materials and products up to date.
At Azierta, we offer quality control laboratories a comprehensive service of updating and implementing new specifications and analytical procedures to ensure that their products are aligned with current regulations.
Pharmacopoeia documentation update methodology
I. Determination of critical materials and products to be integrated into the service.
II. Study of the state of updating of the selected products and materials.
III. Identification of regulatory changes that may affect the client: analysis of updated monographs and GMP environment.
IV. Valuation of the necessary changes for the update and the working times.
V. Implementation of updates: generation of new specifications and analytical procedures in the client's format and ready for review and implementation.