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JULY 5, 2023

13 An FDA-authored paper indicating support for the implementation of CM using science- and risk-based approaches followed soon thereafter. 13 An FDA-authored paper indicating support for the implementation of CM using science- and risk-based approaches followed soon thereafter.

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ISPE

OCTOBER 1, 2022

Flexible technical solutions for the automation of modular plants are in high demand to ensure the consistent implementation of modular plant engineering. Download White Paper. To download this white paper, complete the form below. Once submitted, you will receive a link via the email you provided to download the white paper.

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ISPE

JANUARY 9, 2023

The technical content of the guide has been updated to reflect the increased importance of information technology (IT) service providers including cloud service providers, evolving approaches to software development including incremental and iterative models and methods, and increased use of software tools and automation.

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ISPE

MARCH 29, 2023

Watson, PhD 1 May 2023 When working with the common technical dossier (CTD), the structure of Module 2 “follows the scope and outline of the Body of Data in Module 3,” 1 which can reduce review efficiency. 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Brown Megan E.

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ISPE

MARCH 29, 2023

Watson, PhD 29 March 2023 When working with the common technical dossier (CTD), the structure of Module 2 “follows the scope and outline of the Body of Data in Module 3,” 1 which can reduce review efficiency. 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Brown Megan E.

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ISPE

MAY 9, 2023

Firmino 1 May 2023 The global pandemic has demonstrated that now, more than ever, we need to work toward a global solution and prioritize the harmonization of technical requirements. Positive improvements have been observed in the acceptance and implementation of international standards by various regulatory agencies in Latin America.

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ISPE

AUGUST 29, 2022

In an attempt to address these challenges, in 2019 the ICH endorsed ICH Q12, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (and Annexes). laboratory notebooks, batch records, and technical reports) to submission documents (e.g., Common Technical Document [CTD] sections). Abernathy, J.

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