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WHO Good Practices for research and development facilities of pharmaceutical products
Short Title:
TRS 1044 - Annex 6
Origin/Publisher:
WHO headquarters, Avenue Appia 20, 1211 Geneva 27, Switzerland Telephone: (+ 41 22) 791 21 11, Facsimile (fax): (+ 41 22) 791 3111, Telex: 415 416, Telegraph: UNISANTE GENEVA
Content:
This guideline is specifically applicable to research and development facilities of pharmaceutical products, procedures, processes and data that are intended for transfer and submission for approval in marketing authorization applications, process validation, technology transfer-related
activities (15), validation (7), quality control laboratory activities such as stability testing and development (16), and validation of cleaning
procedures
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