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On October 6, 2024, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy conducted Session 6 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, focusing on HVAC Systems and Qualification in pharmaceuticalmanufacturing. The session began with a keynote address by Thiru M.
Expert Educator: The session was led by Shoeb Kurawadwala, Founder and MD of CN Water and an expert in Water for Pharmaceutical Purposes. He applauded the PULSE initiative for focusing on this crucial aspect of compliance and stressed the importance of compliance with Revised Schedule M.
PCM not ideal for every drug Continuous manufacturing “may not be fit for every pharmaceuticalmanufacturing process, but it can bring some advantages in some cases” compared with traditional batch manufacturing, summarized FDA’s Adam Fisher, Ph.D., It is not intended as a comprehensive summary or report.]
HEOR (Health Economics and Outcomes Research) – is a common term used for experts who collect patient and medical data that proves the real value of the product, how it can influence the quality of life of the patient, and its capacity to compete against similar products present on the market. How HEORs Contribute to Research?
GMP requires that all critical steps of manufacture are reliable or validated. How to perform sampling in quality control process Sampling is the removal of a presentative portion of a lot to understand the lot’s composition and characteristics. This naturally includes laboratory test methods.
Table of Contents Importance of sampling in pharmaceutical industry Pharmaceutical sampling procedures are carried out during and at each major processing step during the manufacturing to ensure the highest quality is attained. What are the types of sampling plans in pharmaceutical industry?
computer systems): Make a separate preliminary technical assessment prior to presenting it to the change committee. Such as product name, batch number, expiry period, ingredients, composition, concentrations, dosage information, storage condition, age restriction, etc. Critical and serious changes (i.e.,
computer systems): Make a separate preliminary technical assessment prior to presenting it to the change committee. Such as product name, batch number, expiry period, ingredients, composition, concentrations, dosage information, storage condition, age restriction, etc. Critical and serious changes (i.e.,
The practice of calling a piece of equipment clean just because it looks clean is not acceptable in the pharmaceuticalmanufacturing process. The amount of residue if present is assessed to have no harmful effect on human use. Why is cleaning validation required? NOEL stands for No Observable Effect Level in cleaning validation.
We will present the rationale behind the qualification decision and reference that with the GAMP (Good Automated Manufacturing Practice) categories in support of the decision you will make. – Disintegration Testers (Critical for assessing the disintegration properties of solid dosage forms).
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