Remove Management Remove Pharmaceutical manufacturing Remove Safety
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Navigating the regulatory challenge of PFAS for pharmaceutical manufacturers

European Pharmaceutical Review

This poses a significant challenge for pharmaceutical manufacturers, not least because of the technical challenges related to operations, supply chain and the environment. This article explores the potential impact of the proposal and considers how manufacturers can ensure the safety and reliability of their products.

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Elevating pharmaceutical manufacturing processes with real-time insights

European Pharmaceutical Review

To address these issues, companies should adopt more advanced production strategies such as continuous flow chemistry, as they can shorten manufacturing processes, increase productivity and throughput. Simultaneously, there is increasing need for stringent quality control and traceability throughout the supply chain to ensure patient safety.

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Guide to Data Integrity

European Pharmaceutical Review

Included in this Guide to Data Integrity: The significance of data integrity in pharmaceutical manufacturing Are you leveraging all the information from your quality control data? A secure, compliant and powerful data management system is critical for maintaining your data integrity compliance.

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Switzerland and US sign drug inspection agreement

European Pharmaceutical Review

Under the agreement with the Swiss Confederation (Switzerland), the Swiss Agency for Therapeutic Products (Swissmedic) and the US Food and Drug Administration (FDA) will be able to utilise each other’s GMP inspections of pharmaceutical manufacturing facilities, avoiding the need for duplicate inspections.

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Regulatory Compliance: Ensuring that pharmaceutical products meet all regulatory requirements and guidelines, including safety, efficacy, labelling, and post-marketing surveillance

eMediWrite

Central Drugs Standard Control Organisation (earlier known as Drugs Controller General of India) are essential to the pharmaceutical production process. They play a crucial role in assuring the efficacy and safety of products given to patients. A company’s systems transparency may also be shown by such data.

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FDA releases analysis on drug product quality in 2022

European Pharmaceutical Review

The report emphasised that a product could degrade under these conditions and negative impact shelf-life, safety, or effectiveness of the drug product. Reflecting on five years of quality control for nitrosamine impurities Warning Letters In FY2022, the FDA issued 72 CGMP-related warning letters to pharmaceutical manufacturing sites.

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AI IN PHARMACEUTICAL MARKETING: Optimizing Automation and Expertise

PM360

Applying AI to GVDs Amassing comprehensive productand market-related data, GVDs demonstrate the value of a pharmaceutical product to various stakeholders, including payers, healthcare providers, and regulatory bodies. It leveraged experts input at key points in the process, to assess and validate the work.