Finished Pharmaceutical Product Specifications. Rutendo Kuwana. Training workshop: Assessment of Interchangeable Multisource Medicines, Kenya, August 2009. Control of FPP. Four subsections Specifications Analytical procedures Validation of analytical procedures
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Training workshop: Assessment of Interchangeable Multisource Medicines, Kenya, August 2009
Validation of analytical procedures
Batch analysis (against full set of specifications)
Full info on three or more batches e.g.
Batch number and size
Date/place of manufacture and QC testing
Purpose of batches
Batch number of API
Specifications are one part of a total control strategy for the FPP designed to ensure product quality and consistency
Others include sound development studies and adherence to GMP; e.g., suitable facilities, a validated manufacturing process, in-process testing, stability testing, API testing, etc.
For the PQP, specifications should be designed to ensure consistency with the biobatch. This then becomes the starting and central point for dossier assessment
Should be as stated in the Pharmacopoeia; or
End of shelf life
the concept applies only to products and establishes more restrictive criteria for the release of the product
Compendial requirements – General chapters e.g. Dissolution, residual solvents AND specific monographs
Important reading for setting specifications:
ICH guideline Q6A (also good for generics):Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances.
ICH Q3B (R2): impurities in new drug products
ICH Q3C (R3): Impurities – Guidelines for Residual Solvents
ICH Q8 (2): Pharmaceutical development
ICH Q10: Pharmaceutical quality system
Identification of the following in FPP
Colorants (skip testing possible)
Physical tests appropriate to dosage form e.g.
LOD, friability, hardness (tabs)
Uniformity of dosage units (mass / content)
Pharmaceutical tests, e.g.
Each API in FDC products
Degradation products (related substances)
Special attention to API-API degradation products
Residual solvents (solvents used in process)
Microbial count / sterility / bacterial endotoxins
Content of APIs in FPP (assay)
Limits 95.0% – 105.0%, unless justified
Content of preservatives
Limits 90.0% – 110.0%, generally acceptable