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New biosimilar pathways – key takeaways from the EMA’s draft reflection paper

European Pharmaceutical Review

4,5,6 However, these benefits are contingent on the ability to generate comprehensive, high-quality analytical and PK data packages. 10 The package, once adopted, is expected to introduce changes to regulatory exclusivity, market access, and competition rules for medicines, including biosimilars, across the EU. Document 9286/25.

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Addressing US FDA challenges in Indian sterile drug manufacturing – Part 2

Express Pharma

Rising expectations for scientific rationale One consistent theme across FDA communications, including 483s, Warning Letters, and guidance documents is the demand for sound scientific justification behind design and operational decisions. Interventions were neither documented nor risk-assessed.

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Biocon Biologics-Walk-In Drive for M.Sc/ B.Sc / M.Pharm/ B.Pharm/ BE/ B.Tech/ M.E/ M.Tech / Diploma On 11th Jan’ 2023

Pharma Pathway

M.Tech / Diploma On 11th Jan’ 2023. M.Tech / Diploma On 11th Jan’ 2023 @ Biocon Biologics. M.Tech / Diploma with 0-10 years of experience in below mentioned skill sets: For Biocon BHD: DP Packaging. Date: 11th Jan’ 2023. Required Documents: Resume. M.Tech / Diploma On 11th Jan’ 2023.

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Chandigarh Calling!

Express Pharma

The latest in this series, Chandigarh Pharma Summit 2023 was successfully hosted by Express Pharma recently. 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.

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FDA guidance highlights E&L considerations for ophthalmic drug products

European Pharmaceutical Review

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

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PDA revises report on glass container manufacturing

European Pharmaceutical Review

Revised for 2023, the Parenteral Drug Association (PDA) has published an update to its Technical Report No. Having been originally published in 2007, then revised in 2013, this latest 2023 edition addresses evolving standards and container types.

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

European Pharmaceutical Review

While it officially applies to the manufacture of sterile medicinal products in the European Union, the revised EU Good Manufacturing Practice (GMP) Annex 1 effectively reset the benchmark for quality standards across the globe on 25 August 2023. Register your details to read more The post How ready are you?