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21	EAC NMRA logo Title: PROCEDURE ON CONFIDENTIALITY AND CONFLICT OF INTEREST Revision #: 0 Page: 1 of 5 Validity: 2 Years Doc #: EAC/NMRA/HNMRA/QM/SOP/001 Prepared by Sign…………. Checked by Add to Reading List Source URL: mrh.eac.int Language: English - Date: 2014-01-25 14:43:03 Rail transport modelling Business Intellectual property law National Model Railroad Association Legal ethics Confidentiality Conflict of interest Trade secret Board of directors Secrecy Ethics Law
22	ANNEX 1: MANUFACTURE OF STERILE MEDICINAL PRODUCTS Principle The manufacture of sterile products is subject to special requirements in order to minimize risks of microbiological contamination, and of particulate and py Add to Reading List Source URL: mrh.eac.int Language: English - Date: 2014-01-25 14:58:48 Microbiology Electron beam Sterilization Medical equipment Aseptic processing Cleanroom Disinfectant Autoclave Dry heat sterilization Hygiene Health Medicine
23	ANNEX 6: HEATING, VENTILATION AND AIR-CONDITIONING SYSTEMS FOR NON-STERILE PHARMACEUTICAL DOSAGE FORMS Introduction Heating, ventilation and air-conditioning (HVAC) play an important role in ensuring the manufacture of q Add to Reading List Source URL: mrh.eac.int Language: English - Date: 2014-01-25 14:58:37 Building biology Chemical engineering Heating ventilating and air conditioning HEPA HVAC Dust collector Air filter Cleanroom Air handler Filters Chemistry Technology
24	ANNEX 7: AUTHORIZED PERSONS The authorized person is defined as a person (among key personnel of a manufacturing establishment) responsible for the release of batches of finished products for sale. Add to Reading List Source URL: mrh.eac.int Language: English - Date: 2014-01-25 14:58:21 Quality Pharmaceuticals policy Technology Management Validation Qualified Person Quality management system Marketing authorization Quality assurance Pharmaceutical industry Business Clinical research
25	ANNEX 4: COMPUTERIZED SYSTEMS Principle Add to Reading List Source URL: mrh.eac.int Language: English - Date: 2014-01-25 14:58:42 Validity Clinical research National security Validation Management Business Backup Computer security Quality assurance Security Data security Pharmaceutical industry
26	Appendix II PRODUCT QUALITY REVIEW REQUIREMENTS FOR GENERIC MEDICINAL PRODUCTS For an established generic product a product quality review may satisfy the requirements of sections 3.2.P[removed]a), 3.2.P.2.3 (a) and 3.2.P Add to Reading List Source URL: mrh.eac.int Language: English - Date: 2014-01-25 14:40:20 Quality Clinical research Validation Verification and validation Review Science Management Philosophy of science Pharmaceutical industry Validity Evaluation
27	DOC Document Add to Reading List Source URL: mrh.eac.int Language: English - Date: 2014-01-25 14:40:23
28	RECOMMENDATIONS FROM EAC PARTNERS STATES’ STAKEHOLDERS Recommendations for CTDs Registration and evaluation of medicines using CTD shall apply to all countries Information on Active Pharmaceutical Ingredients (API) Add to Reading List Source URL: mrh.eac.int Language: English - Date: 2014-01-25 14:40:22 East Africa East African Community Economy of Kenya Economy of Uganda Common Technical Document Regulatory affairs Marketing authorization Africa Pharmaceuticals policy African Union
29	ANNEX 8: QUALITY RISK MANAGEMENT (QRM) 1. INTRODUCTION Add to Reading List Source URL: mrh.eac.int Language: English - Date: 2014-01-25 14:58:20 Pharmaceutical industry Evaluation Actuarial science Risk Validation Risk management Risk assessment Quality by Design Quick response manufacturing Management Ethics Business
30	ANNEX 3: QUALIFICATION AND VALIDATION Principle Add to Reading List Source URL: mrh.eac.int Language: English - Date: 2014-01-25 14:58:45 Science Food safety Technology Quality Validation Verification and validation Business Verification Software development process Pharmaceutical industry Validity Systems engineering