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

APRIL 3, 2023

Adapted and non-standard methods must be validated. Protocols are only used for specific projects such as method validation testing or equipment qualification. – Methods for data analysis and interpretation, including the statistical techniques to be used.

Documentation 52

Documentation Method Validation Compounding Data Entry 52

European Pharmaceutical Review

MARCH 6, 2024

Additionally, the new laboratory offers Ariceum the ability to carry out on-site process, method, validation and formulation development as well as preliminary stability analysis of its radiolabeled compounds.

Method Validation 89

Method Validation Clinical Pharmacology Compounding 89

GMPSOP

SEPTEMBER 27, 2023

However, you must validate the condition and efficacy of their use by conducting trials. Cleaning validation, including analytical method validation, should be conducted for the new product. If it is not, analytical method validation is required. Additional documents included each month.

Method Validation 98

Method Validation Documentation Pharmaceutical Manufacturing Dosage 98

European Pharmaceutical Review

JANUARY 25, 2024

Over time, these can leach “low molecular weight compounds” such as plasticisers, stabilisers and binding agents from CCS components or from labelling components, like inks or adhesives into the drug product. The guidance document also emphasised semipermeable CCSs as another factor to consider in relation to E&Ls.

Documentation 88

Documentation Method Validation Packaging Labelling 88

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