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

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. Internet] European Pharmaceutical Review, Issue 3 2023. 1 References Jaafar-Thiel. cited 2024Mar].

Method Validation 88

Method Validation Clinical Pharmacology Compounding 88

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

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

Documentation 87

Documentation Method Validation Packaging Labelling 87

GMPSOP

SEPTEMBER 27, 2023

Cleaning validation protocol for pharmaceutical industry Pharmaceuticals quality assurance & validation procedures GMPSOP Cleaning validation protocol for pharmaceutical industry Last Updated on September 28, 2023 by Kazi Prev PREVIOUS POST Table of Contents What is cleaning validation in pharmaceutical industry?

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