GOOD DISTRIBUTION PRACTICES (GDP) FOR …
principles of good manufacturing practice (GMP) should be applied. These include, but are not limited to, storage, distribution, transportation, packaging, labelling, documentation and record-keeping practices. The quality of pharmaceutical products can be …
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www.who.intWorking document QAS/15.639/Rev.2 page 4 50 BACKGROUND The World Health Organization (WHO)51 published the first edition of the WHO Guidelines on 52 good manufacturing practices for heating, ventilation and air-conditioning systems for non- 53 sterile pharmaceutical dosage forms in WHO Technical Report Series, No. 937, 2006. After …
Questions and answers on the template for the Qualified ...
www.ema.europa.euActive Pharmaceutical Ingredient (API) manufacturing sites . 8 Which API manufacturing sites should be subject to the QP ... The manufacturing authorisation holder responsible for GMP of the API must be satisfied as contract giver that the auditor is appropriately qualified for the task; this would be subject to ...