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Every pharmaceutical manufacturer, or let us say manufacturer of any goods, want to manufacture a product of best quality which shall complies with all the applicable regulations, guidelines, specifications etc. In pharmaceuticals, this becomes a bigger challenge as the failure…
Pharmaceutical Good Manufacturing Practices (GMP) thrive on Good Documentation Practices (GDP). It is one of the most important requirements of the Quality Management System. It is popularly said that “Anything which is not documented, is not done”. Documentation is the…
No manufacturing firm can design a process where they don’t need to hold the various dispensed, in-process, bulk and finished products for few hours to many months. The duration for which the various materials can be hold under specific environmental…
Quality can be defined as ‘Fitness for Purpose’, i.e.- the products or service should have the right features which satisfies the customers and are thus free from failures (no complaints, no rework etc.). The product should be consistent regarding its…
“Higher quality is less expensive to product than lower quality”- W. Edwards Deming Quality comes with a cost. Often we have found companies struggling to strike a fine balance with the quality and cost. Quality managers sometimes struggles to…