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Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key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. Ophthalmic drug products should be evaluated for extractables and leachables, FDA asserted.

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FDA Documentation Method Validation Packaging 98

European Pharmaceutical Review

NOVEMBER 21, 2024

Can cartridges be used as a standard method for assessing endotoxins across various sample types throughout the industry? Are LAL and rCR cartridges licensed by the FDA? The LAL reagents included in the cartridges are licensed by the US Food and Drug Administration (FDA). rather than the 0.98 outlined by regulations.

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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.

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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.,

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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.

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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).

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Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

The FDA Law Blog

FEBRUARY 13, 2025

Baumhardt, Principal Medical Device Regulatory Expert FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSF). If FDA agrees to the PCCP, such changes can be made without a supplemental marketing submission.

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FDA Documentation Labelling Method Validation 71