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Protocol of QA of drugs in NTEP
Learning ObjectivesMechanism of QA, pre dispatch inspection and post-dispatch inspection,
Quality Assurance of Drugs in NTEP is it ensure that, Each drug used by a patient is safe, efficacious and has appropriate standards of quality.
Procurement of good quality anti TB drugs and ensuring quality of drugs till consumption point is one of the prime objectives of NTEP. To ensure quality and efficacy of anti TB drugs, a comprehensive Quality protocol has been developed and is being followed during the procurement mechanism and supply chain management of drugs up to the consumption points.
Sample Collection Protocol
Maintaining quality of drugs, a system of pre-dispatch & post-dispatch testing of drugs is established.
As per the protocol developed by CTD-
Random samples of First / second-line anti TB drugs shall be picked from all stocking points in the field.
Sent for testing by an independent drug testing laboratory contracted by CTD.
This should be done based on communication sent by CTD to the concerned states and districts.
Resources
1. NTEP Training Modules 5to9, Central TB Division, MoHFW, GoI 2020
Assessment:
| Question | Answer 1 | Answer 2 | Answer 3 | Answer 4 | Correct answer | Correct explanation | Page id | Part of Pre-test | Part of Post-test | |
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State true or false: First line anti-TB drugs are procured from WHO pre-qualified sources only |
True | False |
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1 | First line drugs are procured from World Health Organization (WHO) pre-qualified source & second line drugs from WHO Good Manufacturing Practices (GMP) compliant suppliers under domestic budget (DBS)/World Bank (WB) procurement. | |||||
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