European Pharmaceutical Review

JANUARY 26, 2023

The European Medicines Agency (EMA) has published an updated Q&A document regarding ICH M10 ‘Bioanalytical Method Validation and Study Sample Analysis’. The ICH M10 guideline provides recommendations on the validation of bioanalytical assays for chemical and biological drugs and their metabolites in biological matrices.

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Method Validation Documentation FDA 90

ISPE

MAY 10, 2023

My cousin, who now works for the FDA, has been studying malaria treatments for decades. “My grandfather died of pneumonia in the 1950s. Because he lived in China, he did not have access to penicillin, even though it was invented and being used to treat infections.

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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Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key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 90

ISPE

JANUARY 11, 2023

The cleaning validation life-cycle approach consists of three stages: design, qualification, and continued verification. Often referred to as the validation stage, stage two: qualification confirms that the cleaning procedure under normal conditions meets preestablished acceptance criteria.

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Pharmaceutical Technology

AUGUST 24, 2022

To ensure the quality of FCM assay performance in preclinical and clinical applications, several scientific organizations developed recommendations for FCM instrumentation and method validation. The FDA and/or other regulatory agencies typically request validation reports to evaluate the assay performance for the intended purpose.2,3.

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ISPE

AUGUST 29, 2022

In May 2021, the US Food and Drug Administration (FDA) published a draft industry guidance, ICH Q12: Implementation Considerations for FDA-Regulated Products. The FDA has also offered both early dialogue and training to share knowledge and experience with the industry, providing an excellent example for other regulators to follow.

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Documentation FDA Communication Packaging 52

ISPE

MAY 9, 2023

ANVISA’s analytical method validation 15 and forced degradation 1 requirements are examples of those local regulations that bring additional technical requirements and make a Brazil dossier different from a US or EU dossier (both ICH member countries) and drive the divergence between harmonized global registration process.

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