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FOPE and PharmaState Academy hosts Session 11 of the PULSE series

Express Pharma

He mentioned the necessity of having license number, and manufacturer address on certificates of analysis. He also discussed the importance of having retention samples for raw materials and packaging materials and the role of quality control in investigating deviations and ensuring the stability of raw materials.

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Concept of validation in pharmaceutical industry

GMPSOP

In general, you must formally validate all process steps, production equipment, cleaning methods, testing methods, computer systems and environment, facilities and utilities which are directly used for the manufacture of sterile and non-sterile products. This validation is relatively less comprehensive.

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Validation master plan (VMP) – when and how to create one?

GMPSOP

Following are some examples of validation studies which should be included in the validation master plan: 1. Process validation master plan The process validation master plan accounts for all manufacturing and packaging processes directly employed in the manufacturing and packaging registered products.

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What are the elements of quality control process in pharmaceuticals

GMPSOP

Validated test method A test method comprehensively describes all procedures used in sample analysis. Analytical test method validation guarantees that your test method is robust enough to provide evidence if your product meets the predetermined product specification or conforms to the failure of a product.