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DISTRIBUTION GUIDELINES
WHO TRS 986, 2014 Annex 3
WHO TRS 986, 2014 Annex 3
TELUGU GMP
November 01, 2020
WHO TRS (Technical Report Series) 986, 2014
Annex 3
Model quality assurance system for procurement agencies
Click on the any titles below for complete guidelines
TABLE OF CONTENTS
Glossary
Module I
General requirements for procurement agencies
I.1 Introduction
I.2 Physical resources
I.2.1 Premises
I.2.2 Equipment
I.2.3 Vehicles and transport
I.2.4 Financial systems
I.2.5 Human resources
I.3 Documentation of policies and standards
I.3.1 Quality manual
I.3.2 Standard operating procedures
I.3.3 Change control policy and handling of variations
I.3.4 Code of conduct
I.3.5 Guidelines on conflict of interest
I.3.6 List of prequalified products, manufacturers and suppliers
I.3.7 Maintenance of records
I.3.8 Contract arrangements
Module II
Prequalification
II.1 Introduction
II.2 Principles for prequalification
II.2.1 WHO Model List of essential medicines
II.2.2 Standards for prequalification
II.2.3 Key persons and responsibilities
II.2.3.1 Staff responsible for prequalification
II.2.3.2 Staff responsible for evaluation of product information
II.2.3.3 Staff responsible for inspection of manufacturing sites
II.2.4 Key steps in prequalification
II.2.4.1 Step 1: Soliciting information
II.2.4.2 Step 2: Receive product information
II.2.4.3 Step 3: Screen product information
II.2.4.4 Step 4: Evaluate product information
II.2.4.5 Step 5: Plan, prepare and perform inspections
II.2.4.6 Step 6: Finalize assessment process
II.2.5 Requalification and monitoring
II.2.6 Monitoring of complaints
II.2.7 Cost recovery
II.3 List of suggested SOPs
Module III
Purchasing
III.1 Introduction
III.2 Procurement strategies
III.3 Procurement methods
III.3.1 Restricted tender
III.3.2 Competitive negotiation
III.3.3 Direct procurement
III.3.4 Open tender
III.4 Quality assurance in purchasing
III.5 Key activities in purchasing
III.5.1 Develop a list
III.5.2 Quantification
III.5.3 Procurement method
III.6 Organization and responsibilities
III.7 Monitoring of performance of prequalified manufacturers
III.8 Country legislation
III.9 Donations
III.10 List of suggested SOPs
Module IV
Receipt and storage of purchased products
IV.1 Introduction
IV.2 Pre-shipment quality control
IV.3 Receipt of stock
IV.4 Post-procurement quality control
IV.4.1 Sampling
IV.4.2 Rejected materials
IV.5 Storage of materials and products
IV.5.1 Staff
IV.5.2 Storage areas
IV.5.3 Storage conditions
IV.5.4 Repacking and relabeling
IV.5.5 Miscellaneous and hazardous materials
IV.5.6 Stock control
IV.5.7 Documentation: written instructions and records
IV.6 List of suggested SOPs
Module V
Distribution
V.1 Introduction
V.2 Transport conditions
V.3 Cold chain
V.4 Temperature monitoring and records
V.5 Delivery order
V.6 Dispatch procedures and policies
V.7 Dispatch containers
V.8 Dispatch records
V.9 Traceability
V.10 Port of entry
V.11 List of suggested SOPs
Module VI
Reassessment
VI.1 Introduction
VI.2 Reevaluation of manufacturers
VI.3 Reevaluation of products
VI.4 Monitoring of contracted services
VI.5 List of suggested SOPs
References
Appendix 1.
Example of a code of conduct
Appendix 2.
Example of a guideline on confidentiality
Appendix 3.
Example of a guideline on conflict of interest
Appendix 4.
Example of a standard operating procedure (SOP) for writing an SOP
Appendix 5.
Example of an invitation for expression of interest
Appendix 6.
Interagency finished pharmaceutical product questionnaire based on the model quality assurance system for procurement agencies
Appendix 7.
Example of a standard operating procedure for screening and assessing product information
Appendix 8.
Quality systems recommendations for pharmaceutical inspectorates
Appendix 9.
Technical questionnaire for pharmaceutical manufacturers
Appendix 10.
Example of a standard operating procedure for planning of inspections
Appendix 11.
Example of a standard operating procedure for preparing for an inspection
Appendix 12.
Example of a standard operating procedure for performing an inspection
Appendix 13.
Example of a checklist for good manufacturing practices
Appendix 14.
Guidance on good manufacturing practices: model inspection report
Appendix 15.
Good storage practices
Appendix 16.
Good trade and distribution practices
WHO TRS (Technical Report Series) 986, 2014
Annex 3
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