Active substance for human use
Download Basic requirements for APIs
Download Basic requirements for medicinal products
Download GMP Inspection Reliance
Download Guidance on parametric release
Download Guide for medical products annexes
Download Guide to GDP for Medicinal Products
Download Guideline on exposure limits
Download Guidelines for blood establishments and hospital blood banks
Download Guidelines for computerized systems in regulated
Download Guidelines for preparation of medicinal products
Download Guidelines on risk assessment
Download Inspections of bloods establishments and plasma warehouses
Download Validation of aseptic processes
Download Technical interpretation of revised annex
Download Recommended model for risk based inspection planning
Download Recommendation on sterility testing
Download PIC/s guidance on classification of GMP deficiencies
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