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PDA revises report on glass container manufacturing

European Pharmaceutical Review

According the PDA, the standardised quality criteria in TR 43 are intended as a guidance overview for container manufacturers and for incoming container acceptance inspection at pharmaceutical companies.

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Considerations for safety data migration methods

European Pharmaceutical Review

Pharmaceutical companies regularly transfer databases as they shift to new systems or change service providers in pursuit of higher quality and increased efficiency. However, due to configuration differences between databases (such as code list definitions), cases may not always be an exact replica of the original case.

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What is computer system validation (CSV) in GMP

GMPSOP

Additional documents included each month. Category 1 Standard hardware components Standard hardware components should be documented, including manufacturer or supplier details and version numbers. Any hardware configuration should be defined in the design documentation and verified in the installation qualification stage.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

It begs the question of why only two botanical drug products have obtained FDA approval and fulfilled the Botanical Guidance definition of a botanical product. Prior to joining Fieldfisher, Taly spent four years working as in-house counsel for a leading tech company helping launch products across multiple EU markets.

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Deviation investigation guidelines in the pharmaceutical industry

GMPSOP

Additional documents included each month. Additional documents included each month. Subscribe Different types of deviations in pharmaceuticals There are two types of deviations. Additional documents included each month. Additional documents included each month. All written and updated by GMP experts. recall, etc.)

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Considerations for a successful tech transfer of a biologics upstream process

European Pharmaceutical Review

The emergence of huge pharmaceutical companies with discrete centres of excellence in geographically dispersed locations has upended the classic model of one-stop shopping for all development functions. Success requires close attention to the principles of tech transfer to ensure the smoothest path to market.

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Complete guide on pharmaceutical medical affairs

Viseven

A medical affair is a pharmaceutical or medical company department that communicates the correct information about the drug or medical device to doctors, other medical practitioners and healthcare providers. Medical affairs definition uses clinical and scientific information to communicate the efficiency of a drug.