epicur

JANUARY 18, 2024

November 1, 2023, marked the effective date of the revised United States Pharmacopeia (USP) chapters <795> and <797> Under these revised guidelines, 503A compounding pharmacies are required to comply with the new beyond-use date (BUD) regulations on their preparations, which are much shorter than what was previously allowed.

Compounding 52

Compounding Compounding Pharmacies Dosage Method Validation 52

GMPSOP

SEPTEMBER 27, 2023

However, you must validate the condition and efficacy of their use by conducting trials. Select the worst-case product for cleaning validation For multi-product equipment, it is not practical to validate the cleaning of all products that have one cleaning process and where products are alike in formulation and dosage form.

Method Validation 98

Method Validation Documentation Pharmaceutical Manufacturing Dosage 98

GMPSOP

OCTOBER 28, 2023

Validated test method A test method comprehensively describes all procedures used in sample analysis. Analytical test method validation guarantees that your test method is robust enough to provide evidence if your product meets the predetermined product specification or conforms to the failure of a product.

Documentation 52

Documentation Method Validation Packaging Data Entry 52