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? After a long drafting and harmonization phase, the EC published their new GMP Annex 1 2 in August 2022. This was followed in September 2022 by the publication of the PIC/S’s identical Annex 1.

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ISPE

SEPTEMBER 12, 2022

2022 ISPE Aseptic Conference: Regulatory Panel Discusses ATMPs, Data Integrity, Inspections, & More. Mon, 09/12/2022 - 15:18. September / October 2022. 2022 ISPE Aseptic Conference: Regulatory Panel Discusses ATMPs, Data Integrity, Inspections, & More. 12 September 2022. 2022 PIC/S Chair, Sr.

FDA 52

FDA Documentation Communication 52

ISPE

JULY 6, 2023

In recent years, global pharmaceutical supply chains, still based on traditional batch- and intermediates-based manufacturing, were overwhelmed by their own vulnerabilities and inefficiencies, and were stressed to the brink of failure as a result of the SARS-COV-2 pandemic. This is demonstrated by the rise from $1.05 billion US in 2021 to $1.9

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MARCH 6, 2023

Challenges for Net Zero Carbon Pharmaceutical Manufacturing Trudy Patterson Mon, 03/06/2023 - 12:40 Features March / April 2023 Challenges for Net Zero Carbon Pharmaceutical Manufacturing Keith M. Sixth Assessment Report: Climate Change 2021: The Physical Science Basis.” Finalized 9 August 2021. C global warming scenario.

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Packaging Pharmaceutical Companies Pharmaceutical Companies Compounding 52

ISPE

AUGUST 29, 2022

Mon, 08/29/2022 - 15:46. September / October 2022. 1 September 2022. Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. HC is expected to have full implementation of ICH Q12 by late 2022. Trudy Patterson.

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Documentation FDA Communication Packaging 52

ISPE

OCTOBER 26, 2022

Wed, 10/26/2022 - 16:08. November / December 2022. 1 November 2022. ATMP facilities are different from conventional pharmaceutical facilities that process other traditional modalities, such as vaccines and monoclonal antibodies (mAbs), and often require heightened segregation and smaller footprints. Trudy Patterson.

Vaccines 97

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ISPE

MARCH 29, 2023

3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. link] 2 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System.” The authors propose using Module 2.3

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. link] 2 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System.” The authors propose using Module 2.3

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

SEPTEMBER 8, 2023

The pharmaceutical industry is increasingly relying on such innovative technologies to automate many functions previously performed by humans. The listed requirements in the draft regulation for developing and operating high-risk AI systems are all based on good engineering practice. Main section chapter 7.12 Regulatory Regulatory

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Documentation 52

ISPE

AUGUST 30, 2022

Mon, 08/29/2022 - 20:53. September / October 2022. 1 September 2022. The pharmaceutical manufacturing supply chain starts with the raw materials, which are needed to ensure drug availability for patients. Trudy Patterson. Regulatory Landscape for Raw Materials: CMC Considerations. Jacqueline E.

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

MARCH 15, 2023

Whitford Emily Heffernan, PE Aoife Kelly 1 March 2023 Many emerging tools and technologies support the environmental sustainability of the pharmaceutical industry. Accessed 3 December 2022. October 2015. 7 November 2022. www.weforum.org/agenda/2022/11/3-ways-healthcare-systems-carbon-footprint/ 5 European Commission.

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Packaging Labelling Health Compliance Process Improvement 52

ISPE

OCTOBER 27, 2022

Thu, 10/27/2022 - 10:14. November / December 2022. 1 November 2022. C sponsors currently address numerous emerging pharmaceutical entities, as well as manufacturing platforms, modes, and scale. DPS project experience, December 2011–August 2022. Published 13 May 2022. 2 (2022): 199-209. Stephen Judd.

Packaging 52

Packaging Communication Immunization Vaccines 52

ISPE

SEPTEMBER 10, 2023

An Evaluation of Postapproval CMC Change Timelines Trudy Patterson Sun, 09/10/2023 - 11:22 Features September / October 2023 An Evaluation of Postapproval CMC Change Timelines Rob Harris, PhD Meike Vanhooren Kara Follmann, PhD Beth Kendsersky Timothy J.N. WHO Expert Committee on Specifications for Pharmaceutical Preparations.”

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