Documentation Events Pharmaceutical Manufacturing 
Drug Patent Watch
DECEMBER 10, 2024
Quality Documentation and Manufacturing Expertise CDMOs are experienced in generating high-quality documentation required for regulatory submissions and have extensive expertise in drug development and manufacturing.
Express Pharma
JUNE 12, 2024
With an impressive lineup of speakers and panelists, the summit promises deep insights into the evolving landscape of pharmaceutical manufacturing. The participants can gain deeper insights on recent focus areas such as Quality Management Maturity Models, Data and Documentation Imperative and Talent Capability Building.
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pharmaphorum
MAY 25, 2022
When events moved online, societies and associations recognised the wider access afforded by “virtual”, and now, as the world slowly gets back on track, many have opted for a hybrid model that offers the best of both. Here, we take a look at the top five takeaways from the document: 1. The codes still apply. End of the host country.
GMPSOP
JANUARY 29, 2025
users, raw materials, components, intermediates, finished products, departments, facilities, equipment, documents, batch numbers, test methods, specifications, processing lines, suppliers, and many more items as required). – Appropriate controls over systems documentation. The 21 CFR Part 11 also tells us that: i.
PharmaState Academy
FEBRUARY 10, 2025
Revised Schedule M: A Complete Guide to Pharma Compliance Introduction Revised Schedule M is a critical update to Indias pharmaceutical manufacturing regulations. It aligns Good Manufacturing Practices (GMP) with international standards, ensuring quality, safety, and efficacy in drug production. What is Revised Schedule M?
pharmaphorum
JULY 28, 2022
While navigating changes has long been a challenge for the industry, the last two years’ events have made supply chain management significantly more difficult. The extraordinary scenario of producing vaccines for a global pandemic led to a well-documented shortage of vials, stoppers, and syringes, and finding a solution is no easy task.
GMPSOP
MARCH 8, 2024
Out of trend results What is the origin of out of specification events? In the early 1990s, the Food and Drug Administration (FDA) inspected a major generic manufacturer in the US and identified concerns with failing test results. The manufacturer challenged the FDA’s view, ending in the US District Court.
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