Category Guidelines

WHO issues draft guidelines on GMP for investigational products and GP for R&D facilities

The World Health Organisation (WHO) has recently issued draft guidelines for comment, on Good Manufacturing Practices (GMP) for investigational products and Good Practices for research and development facilities of pharmaceutical products. WHO good manufacturing practices for investigational products (updated guideline)…

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Health Canada implements ICH Guidance Q3C(R8): Impurities: Guideline for Residual Solvents

Health Canada has implemented ICH Guidance Q3C(R8): Impurities: Guideline for Residual Solvents. Q3C(R8) was developed by the appropriate ICH Expert Working Group. It has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly…

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