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Table Of Contents

Introduction
Why the quality of artemisinin-based antimalarial medicines is important
Challenges in ensuring the quality of artemisinin-based antimalarial medicines
Figure 1. Levels of procurement of artemisinin-based antimalarial medicines
Procurement checklist
1.1 WHO guidelines
Table 1. WHO-recommended medicines for the treatment of malaria
1.2 National guidelines
1.3 Special situations
1.4 Safe, effective antimalarial medicines and preferred presentations
Table 2. Preferred antimalarial product presentations (as of September 2009)
2.2 Forecasting
3.1 National funding
3.2 Donor funding
Table 3. Model specification for a pharmaceutical product
Selecting the procurement method and preparing tender documents
5.1 Procurement method
5.2 Tender documentation
6.2 Stringent regulatory authorities (SRAs)
6.4 Sources of quality-assured antimalarial finished pharmaceutical products
Table 4. Quality-assured antimalarial finished pharmaceutical products (FPPs)
7.1 Supplier criteria
7.2 Product criteria
8.1 Elements of product quality
8.2 Types of pharmaceutical products
8.3 Bioavailability and bioequivalence
8.4 Product stability
Table 5. Conditions for zone IV texting as per WHO guidelines
Table 6. Storage instructions as per WHO recommendations
8.5 Pharmaceutical specifications and analytical methods
Table 7. General pharmacopoeial requirements for dosage forms
Table 8. Requirements for analytical methods
8.6 Control of active pharmaceutical ingredients
8.7 Good manufacturing practice (GMP)
8.8 Packaging
8.9 Labelling
8.10 Product information and users
Table 9. Information on use for prescribers and patients
9.1 Pricing information
9.2 Operational costs
9.3 Patents
11.1 Role of preshipment inspection and quality control
11.2 Contracting a laboratory
11.3 Shared arrangements
11.4 Preparation for sampling
11.5 Sampling for preshipment quality control
11.6 Interpretation of results
12.1 Before receipt of each shipment
12.2 On receipt of each shipment
12.3 After receipt of each shipment
13.1 Extent of testing
13.2 Selection of laboratory
13.3 Interpretation of results
13.4 Reporting the results of quality control
14.1 Temperature monitoring and control
14.2 Stock control
14.3 Security and control of access
14.4 Batch traceability and recalls
16.2 Handling variations
References1
Annexes
Stringent regulatory authorities
Confirmed long-term stability testing conditions for countries
Index
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Good Practice for ACT

Good Practice for ACT

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Published by: drfarooqmd on Jan 16, 2014
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01/23/2014

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