European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. 11 This requirement directly contradicts what is included in Article 63. 11 This requirement directly contradicts what is included in Article 63. References European Commission, (26 April 2023).

Packaging 82

Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 82

ISPE

JANUARY 11, 2023

Life-Cycle Approach to Cleaning Topical Drug Products Trudy Patterson Wed, 01/11/2023 - 10:17 Technical January / February 2023 Life-Cycle Approach to Cleaning Topical Drug Products Dijana Hadziselimovic Kamini I. Rao Nicole Granda Alvarez Paul T. Lopolito Steven M. 1 US Food and Drug Administration.

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Method Validation Documentation Packaging Compounding 52

The People's Pharmacy

MAY 8, 2023

” Its investigation into foreign FDA inspections is shocking (April 19, 2023): “A ProPublica analysis of FDA inspection data as of April shows that the agency’s inspections of overseas drug manufacturers, located mostly in India and China, has dropped precipitously even as the number of manufacturers has remained relatively steady.

FDA 72

FDA Pharmaceutical Companies Pharmaceutical Companies Medical Schools 72

ISPE

MAY 11, 2023

™ Roadmap Trudy Patterson Thu, 05/11/2023 - 13:25 Technical May / June 2023 Methodology to Define a Pharma 4.0™ ™ Roadmap Emmie Heeren AREND JAN WASSINK Venkateshwar Rao Nalluri, PhD Sebastian NIEDERHAUSER 1 May 2023 In the context of data integrity, data flows are essential. Methodology to Define a Pharma 4.0™ to Industry 4.0

Packaging 52

Packaging Documentation Communication Data Entry 52

ISPE

SEPTEMBER 11, 2023

Trudy Patterson Mon, 09/11/2023 - 06:10 Features September / October 2023 Air Speed Qualification: At Working Position or Working Level? This article provides background knowledge from literature and data from experiments to enhance the discussion. x, a free and open-source computational fluid dynamics (CFD) software package.

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

SEPTEMBER 11, 2023

Considerations for a Decentralized Manufacturing Paradigm Trudy Patterson Mon, 09/11/2023 - 06:47 Features September / October 2023 Considerations for a Decentralized Manufacturing Paradigm Marquerita Algorri, PhD Ting Wang, PhD Jocelyn X. 7 June 2023. McQueen Nina S. 5 , 13 , 27 , 32 1 US Food and Drug Administration.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MAY 9, 2023

CMC Requirements for New Drug Registration in Latin America Trudy Patterson Tue, 05/09/2023 - 11:23 Features May / June 2023 CMC Requirements for New Drug Registration in Latin America Aicha Otmani Flavia C. This article offers an overview of the CMC requirements for the small molecules product registration process in Latin America.

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Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52