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The Role of Good Manufacturing Practice (GMP) in Generic Drug Manufacturing: Ensuring Quality and Safety

Drug Patent Watch

I'm talking about Good Manufacturing Practice (GMP), a set of guidelines that govern the production, testing, and packaging of generic drugs. Documentation and record-keeping : Manufacturers must maintain accurate and detailed records of their manufacturing processes, including batch records, quality control records, and training records.

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How ready are you? Preparing for the impact of EU GMP Annex 1 on primary packaging

European Pharmaceutical Review

Indeed, a key aspect of EU GMP Annex 1 is the requirement for pharmaceutical manufacturers to develop a comprehensive Contamination Control Strategy (CCS) that documents their approach to assuring the sterile drug product’s high quality and, therefore, enhancing patient safety. Register your details to read more The post How ready are you?

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Chandigarh Calling!

Express Pharma

In this article, we delve into the highlights of the Chandigarh Pharma Summit 2023, and showcase the key takeaways and insights from the presentations and discussions at the event. Embracing innovation in pharma packaging is vital become future Shivaji Chakraborty, Asst.

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Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing

European Pharmaceutical Review

Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. Any documentation, such as validation reports then helps with compliance and later regulatory submissions and requests.

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Episode 864: Why Did ISMP Remove the Do Not Crush List from Their Website?

Pharmacy Joe

Subscribe on iTunes , Android , or Stitcher If you navigate to the page on the website for the Institute for Safe Medication Practices that once hosted the document titled “Oral Dosage Forms That Should Not Be Crushed” you will instead find a notice that the list has been removed from the ISMP website.

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How to ensure quality and compliance in clinical supply chain management

GMPSOP

To maintain the integrity and safety of these investigational products, you must adhere to Good Manufacturing Practice (GMP), FDA Clinical Trail Guidance Documents , and relevant ISO or EN standards. Additional documents included each month. Compliance with EN 46001 and 21 CFR 820 is essential for medical devices.

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Navigating the regulatory challenge of PFAS for pharmaceutical manufacturers

European Pharmaceutical Review

This article explores the potential impact of the proposal and considers how manufacturers can ensure the safety and reliability of their products. billion Global concerns surrounding PFAS, or per- and polyfluoroalkyl substances, are due to their well-documented effects on human health and the environment.