Transcript TB Procurement Training Guide

TB medicines
a Quality
Assurance
perspective
Unit Objectives
1. Specify what is meant by quality assurance in managing
the supply of tuberculosis medicines
2. Identify factors affecting pharmaceutical quality
3. Describe the components of a quality assurance system
4. Identify practical technical and managerial procedures
to assure pharmaceutical quality
5. Identify resources for assistance in quality assurance
activities
QA & QC
1. What is your definition of
Quality Assurance?
2. What is Quality Control?
QA & QC
Quality Assurance…..
a constant awareness!
Quality Control…..
are specific actions you take!
QA & QC
Power to the buyer !!
Demand what YOU want/need!
Accept only what you demanded!
Determinants of Pharmaceutical
Product Quality (1)
Manufacturing:
• Medicine formulation
• Equipment and maintenance in factory
• Plant environment
• Manufacturing process
• Quality control
• Active ingredients
• Inactive ingredients
• Packaging of immediate and external containers
Determinants of Pharmaceutical
Product Quality (2)
• Handling and storage conditions,
(humidity, light, temperature, rain, dropping)
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Shipment / transport
(Air) port handling
Transport to CMS
Storage conditions
Distribution within your health system
Critical Elements of QA for
Pharmaceutical Procurement
• Product selection
• Supplier qualification
for medicine selection
• Product certification
 Batch certification
• Contract specifications
• Inspection of shipments
• Laboratory testing
• Appropriate storage,
transport, dispensing,
and use procedures
• Product monitoring
system
Actions to Obtain Good-Quality (TB)
Products (1)
• Careful Product Selection
 Safe, effective, quality medicines as evidenced by
clinical trials, reference literature
 Dosage forms that have longer shelf life
 Properly packaged products
• Specify what YOU want!
Actions to Obtain Good-Quality (TB)
Products (2)
Careful Supplier Qualification for Selected Medicines
 Select competitively by restricted tender, =prequalification
 Request samples before purchase
 Analyze information on supplier reliability and product
quality
 Select suppliers who can provide drug certifications
 Verify quality of medicines with known bioavailability and
stability problems by lab tests
Actions to Obtain Good-Quality
Tuberculosis Products (3)
• Bidding Document stipulate Specifications for
Fixed-Dose Combinations
 Comparative rifampicin bioavailability results equivalent
to rifampicin single-drug standard methods
 Comparative dissolution tests for all components
 Declaration of consistency between the starting and
subsequent batches
• Specify what YOU want!
Actions to Obtain Good-Quality
Tuberculosis Products (4)
• Bidding Document Specifications for FixedDose Combinations
 Correlation over time between dissolution tests
of different batches
 Statement that raw materials are in
accordance with reference specifications
 Follow-up lab analysis data for each batch
• Specify what YOU want/need!
4-FDC (RHZE)
R: molecular size & structure of API
R: degrades in daylight
R+H: interact (humidity!)
HPLC peak of impurities can be hidden by R peak
E: is highly hygroscopic: --- Coated tablets
Dark coloured blisters, good quality alu foil.
Too compact: ………. Disintegration & Dissolution!
But High Quality 4-FDCs exist, if you insist!
Actions to Obtain Good-Quality (TB)
Products (5)
• Product Certification
 Obtain (WHO-)GMP certificate from drug
regulatory authority, PIC/s, ICH or other stringent
regulatory authority
 Obtain WHO-type certificates (CPP) from NDRA
agency of exporting country
Actions to Obtain Good-Quality
Products (6)
• Batch Certificates
 Obtain certificate of batch analysis from
manufacturer or international quality control
organization (for every batch!?)
• Drug Regulatory Authorities
 Verify registration of selected drugs
Actions to Obtain Good-Quality (TB)
Products (7)
• Contract Specifications
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Pharmacopeia + year reference standard
Local language for product label
Minimum information to provide on label…….!
Any other additional information required
Standards for packaging to meet specific
storage and transport conditions
 Specify what YOU need/want!
Actions to verify the Quality
of Shipped Medicines
• Physical inspection of each shipment:
 packing list / quantities, batch numbers,
 Packing intact: stains, cracks or folds,
pinholes in blisters,
 Presentation of drugs: colour, smell etc
• Laboratory testing:
 standardized or random sampling
 Pharmacopoeia
 Sterility for injectables
Actions to Monitor Product Quality (1)
Product problem reporting system indicates: —
 Who should report quality problem
 How to fill out reporting form, where to send, and to
whom
 Follow-up information to be provided
 Criteria for retesting product
Actions to Monitor Product Quality (2)
Product recall system allows quick response
 Inventory system tracks batch to facility level,
classifies type of recall, monitors the recall
Summary
• If Quality Assurance for TB drugs or other
medicines insufficient: (see worksheet hand-out)
• Please make provision in your submission to
GFAMT to improve the same.
 Identify gaps, select items to address short
term / medium term
 Consider procuring from Quality Assured
sources only: MSF, UNICEF, IDA, GLC, GDF
Management Challenge
1. Hand-out: 15 minutes to fill-out
Include necessary actions in
your PMS plan!
2. Sample Quality requirements
in tender letter
Management Challenge
Buyer
Be
AWARE!