epicur

JANUARY 18, 2024

While both BUDs and expiration dates serve a similar purpose of decreasing patient risks associated with any changes a medication may undergo during storage, expiration dates have key advantages : Expiration dates have a high degree of accuracy—they are determined using stability testing methods validated by cGMP regulations enforced by the FDA.

Compounding 52

Compounding Compounding Pharmacies Dosage Method Validation 52

GMPSOP

SEPTEMBER 27, 2023

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. If it is not, analytical method validation is required.

Method Validation 98

Method Validation Documentation Pharmaceutical Manufacturing Dosage 98

Express Pharma

MAY 22, 2023

Drawing comparisons between R&D and manufacturing practices in the pharma and nutra sectors, the experts said that nutraceutical manufacturers should ensure that only potent ingredients with the right dosages backed by clinical studies are used in their products.

Dosage 105

Dosage Method Validation Labelling Immunity 105

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

GMPSOP

JUNE 16, 2023

In this option, the RL has to assess all the risks and mitigate those risks by repeating the test parameters and matching the results against the original validation data. It’s essential to review the TL’s validation approach in accordance with current ICH Q2 guidelines and ensure that it covers the intended use of the method.

Documentation 52

Documentation Dosage Communication Method Validation 52