ISPE

JUNE 2, 2023

For more information, please contact: communities@ispe.org. reduce non-value-added tests) Contract lab management Reference standards & critical reagent management Rapid micro testing Training (e.g., reduce non-value-added tests) Contract lab management Reference standards & critical reagent management Rapid micro testing Training (e.g.,

Method Validation 98

Method Validation 98

European Pharmaceutical Review

JANUARY 25, 2024

Moreover, manufacturers should document information about their safety thresholds, the guidance stated. Description on how the risks are mitigated, such as by conducting leachables studies, also should be included, the guidance noted.

FDA 98

FDA Documentation Method Validation Packaging 98

European Pharmaceutical Review

NOVEMBER 21, 2024

For further information, visit: www.criver.com About the authors Courtney Wachtel, BS is Product Manager, Microbial Solutions, Charles River – Endosafe. It’s important to note again that Charles River’s cartridges meet USP and EP standards and are FDA-approved for BET.

Method Validation 52

Method Validation FDA 52

Pharmaceutical Technology

AUGUST 24, 2022

A central lab with a global footprint provides both the efficient transportation arrangement and scientific rigor required to unlock the valuable information contained within patients’ biological samples. The information obtained from FCM informs diagnosis, treatment, and monitoring of residual or relapsed disease.

Method Validation 52

Method Validation Immunization FDA 52

ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g.,

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

JANUARY 11, 2023

Cleaning is an important component of a manufacturing process, and the process life-cycle approach should be followed for cleaning validation. The cleaning validation life-cycle approach consists of three stages: design, qualification, and continued verification. 1 US Food and Drug Administration. US Code Title 21: Food and Drugs.

Method Validation 52

Method Validation Documentation Packaging Compounding 52

ISPE

MAY 9, 2023

The information results from the authors’ experience working in a global company and managing successful drug registrations in the Latin American region. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., the site where development occurs versus where commercialization is intended).

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52