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WHO | World Health Organization

130 World Health OrganizationWHO Technical Report Series, No. 957, 2010 Annex 2W HO good manufacturing practices for active pharmaceutical ingredients1. Introduction Objective Regulatory applicability Scope2. Quality management Principles Responsibilities of the quality unit(s) Responsibility for production activities Internal audits (self-inspection) Product quality review3. Personnel Personnel qualifi cations Personnel hygiene Consultants4. Buildings and facilities Design and construction Utilities Water Containment Lighting Sewage and refuse Sanitation and maintenance5. Process equipment Design and construction Equipment maintenance and cleaning Calibration Computerized systems6.

WHO | World Health Organization

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