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FOPE and PharmaState Academy hosts Session 11 of the PULSE series

Express Pharma

On December 15, 2024, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy hosted Session 11 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, focusing on Good Practices In Quality Control. Dr Khurana stressed the importance of risk-based testing and the need for proper documentation.

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FOPE & PharmaState Academy host Session 12 of the PULSE series

Express Pharma

On December 29, 2024, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy hosted Session 12 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, focusing on Complaints and Product Recall. The session provided clarity on the guidelines and cleared the queries of the pharma professionals.

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Pharmacy Law and Licensing Highlights 2025

FDA Law Blog: Biosimilars

By Sara M Keup In reviewing some new 2025 pharmacy rules/laws a couple interesting changes caught this bloggers attention: As of December 30, 2024, Missouri has rolled out new rules related to prescription drug delivery requirements. The California Board of Pharmacy updated many of the application forms and guidelines in late 2024.

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FDA guidance highlights E&L considerations for ophthalmic drug products

European Pharmaceutical Review

This document is revised from a version published in October 2023. Firstly, leachables can compromise a products quality and therapeutic effect, by potentially interacting with the formulated drug product, the document reported. Moreover, manufacturers should document information about their safety thresholds, the guidance stated.

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EMCrit 1:1 Nursing Podcast 002 – Post-Intubation Sedation (Pain, Agitation, & Delirium)

EMCrit Project

Intubated patients in the ED should have soft, wrist restraints places without the need for arduous, high-risk documentation or sitters Intubation Checklist EMCrit 176 – Updated EMCrit Rapid Sequence Intubation Checklist Awareness during Paralysis EMCrit 331 – Awareness after Resus RSI and ICU Paralysis – It is Unacceptable!!!

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FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

FDA Law Blog: Biosimilars

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. However, as your high-school literature teacher warned youto ace the test, you need to read the book, ahem, source regulations, guidance, or other policy documents.

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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.