European Pharmaceutical Review

NOVEMBER 15, 2022

Since their outset the GAMP guides have promoted using a balanced risk-based pragmatism to achieve compliance and the July 2022 release of GAMP 5 second edition strongly encourages the use of critical thinking to support that. This article primarily discusses Appendix D5 Testing of Computerized Systems and Appendix M12 Critical Thinking.

Documentation 84

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 84

The People's Pharmacy

MAY 8, 2023

In fiscal year 2019, the year before the COVID-19 pandemic limited travel and movement, the FDA inspected 37% of the nearly 2,500 overseas manufacturers; in 2022, the agency only inspected 6% of around 2,800.” Because of lax standards or outright fraud, the FDA has tried harder to visit drug companies in that country.

FDA 72

FDA Pharmaceutical Companies Pharmaceutical Companies Medical Schools 72

pharmaphorum

JANUARY 9, 2023

This article is the first part of three and covers the first three of nine predictions, here focusing on global healthcare environmental challenges and what they mean for the pharmaceutical industry. Regulatory divergence became apparent in 2022 and could increase in 2023. Pharma’s starting to wake up to this. Pharma boxed in?

Vaccines 92

Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 92

ISPE

JULY 6, 2023

1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. This article highlights the overall benefits and scope of Q13, as well as what we see as the next set of opportunities to further expand the adoption of CM across the globe.

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ISPE

JULY 10, 2023

For the sake of readability, we will use it interchangeably for both interpretations throughout the article. We transfer the capabilities of ChatGPT to specific use in context to the pharmaceutical value chain, and elaborate on the context of use in the regulated areas of pharma, considering ChatGPT and LLMs in general.

Labelling 52

Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

JULY 1, 2022

Although there are currently no set metrics or prescribed areas of focus, there are several key areas that pharmaceutical companies can pinpoint when measuring the S in ESG. For pharmaceutical companies, ensuring that human rights are protected by offering transparency and performing due diligence in global supply chains is key.

Pharmaceutical Companies 85

Pharmaceutical Companies Pharmaceutical Companies Documentation 85

ISPE

JULY 5, 2023

This article discusses how US regulators addressed the regulatory hurdles related to CM to broaden its adoption through engagement, regulatory science, guidance, and international harmonization. 2 , 3 Key differences between CM of pharmaceuticals versus other chemicals relate primarily to volume and runtime.

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52

ISPE

MAY 9, 2023

In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceutical companies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

JULY 6, 2023

This article provides a review on the current state of CM implementation, offers insights into life cycle management and regulatory aspects, and explains how a data- and knowledge-centric approach to risk management can help CM achieve its full potential. 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 7, 2023

link] As emphasized at the recent UN Climate Change Conference COP27 (held at the end of 2022 in Sharm el-Sheik, Egypt), international focus is now on implementation. 3 , 4 Most companies have some existing initiatives underway, but many do not yet have a fully comprehensive and integrated program. October 2015. link] 2 United Nations.

Health and Personal Care Stores 52

Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52

ISPE

MARCH 7, 2023

This article reviews two case studies that cover sustainable pack types and extension of shelf life. The Global Use of Medicines 2022.” Increasing the Circularity of Packaging Along Pharmaceuticals Value Chain.” 8 (2022): 4715–4731. The Pharmaceutical Industry in Figures. Key Data 2022.” 9 December 2021.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

ISPE

SEPTEMBER 10, 2023

In this article, we describe the assessment of lag time for global regulatory approvals of postapproval CMC changes for multiple products over a three-year period. Pharmaceutical Engineering 42, no. 1 (January/February 2022). link] 6 International Pharmaceutical Regulators Programme. Cauchon, T. Hedberg, M. Lepore, et al.

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