Revised GMP principles by EU on Qualification and Validation

Good manufacturing practices guidelines are of significant importance to provide guidance for interpretation of principles and guidelines of qualification and validation applicable to the facilities, equipments, utilities and processes used for the manufacture of medicinal products. According to new draft from European Commission for GMP guidelines, the manufacturers of the drug products should assure the critical parameters of their processes through qualification and validation of the product and process.

Currently, EU has issued the revision of Annex 15 of EU Guidelines for Good Manufacturing Practices for Medicinal Products for Human and Veterinary use (Vol. 4). This Annex 15 further includes changes to other sections of the EU-GMP Guide Part I, Annex 11(Computerized system), ICH Q8, Q9, Q10 and Q11, QWP guidance on process validation and changes in manufacturing technology.

This revised draft also depicts the principles which should be followed for qualification and validation for the manufacturing of medicinal products.

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