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FOPE and PharmaState Academy hosts Session 11 of the PULSE series

Express Pharma

He presented on good practices in quality control, highlighting the importance of appropriate qualifications and experience, and adequate facilities for storage and sampling. He also stressed the importance of reviewing batch records and analytical records and the need for clear documentation practices.

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FOPE & PharmaState Academy host Session 12 of the PULSE series

Express Pharma

The session was led by A V Jayakumar, President- Quality, Ajanta Pharma Presentation highlights Jayakumar provided valuable insights from his extensive experience in quality management and regulatory compliance. He recounted his own experience working with investigative teams and the importance of being proactive when handling complaints.

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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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Chandigarh Calling!

Express Pharma

It also showcased why Chandigarh, with a conducive business climate, access to skilled manpower, and good infrastructure, presents an opportunity for pharma companies to expand their horizons. Embracing innovation in pharma packaging is vital become future Shivaji Chakraborty, Asst.

Packaging 104
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AI-driven drug discovery, precision medicine, and sustainable manufacturing can redefine the pharma industry

Express Pharma

and Europe held manufacturers accountable for their environmental impact, leading to an increase in partnerships with tech companies focused on sustainable packaging and production solutions. Collaborative R&D models and partnerships also present an opportunity for Indian pharma companies to mitigate the risks and costs of innovation.

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Pharmacovigilance deep dive: risk minimisation measures

European Pharmaceutical Review

The call for transparency in the presentation of study sampling methodology should not be limited to RMM effectiveness studies. The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. Any additional comments?