Transcript Quality Assurance Processes for TB Drugs

Quality Assurance Processes
for TB Drugs
GDF Quality Assurance
Processes
The products GDF procures are subject to the
following Quality Assurance criteria:
• Manufacturers' compliance with WHO/GMP
standards as assessed under the TB
Prequalification Project.
GMP
Product compliance with either:
• Option (I): WHO-recommended standards for
medicines as assessed under the aforementioned
WHO/PSM Procurement, Quality and Sourcing
Project: Access to Anti-Tuberculosis Drugs of
Acceptable Quality i.e. Product is Prequalified
Product Compliance: Option I
• Option (II): compliance with the assessment criteria as determined
by WHO/PSM & product dossiers are assessed against these criteria
by an ad hoc transparent, independent expert committee convened
by WHO/PSM at the request of GDF.
• The ad hoc committee is drawn from the same team of evaluators
who assess product dossiers for quality aspects and for efficacy and
safety (or bio-equivalence) under the TB Prequalification Project.
• Where a product which complies with Option I has at least 3
manufacturers who comply with GDF tender criteria GDF limits
procurement of that product to those manufacturers.
Product Compliance: Option II
All batches of all products procured by GDF, irrespective of whether
product compliance falls under option I or option II, are subject to
independent quality control testing by a laboratory that:
 (a) is from a country that is a member of the Pharmaceutical
Inspection Cooperation Scheme (PIC/S)
 (b) from a country that is party to the International Conference on
Harmonization of Technical Requirements for the Registration of
Pharmaceuticals for Human Use (ICH) or
 (c) has been assessed by WHO PSM/QSM and found to meet
recommended international norms and standards for the analysis of
products
Quality Control
• GDF adheres to GFATM compliance list where
products are included there
• GDF adheres to its own QA criteria where product
is not on GFATM compliance list
• After next GDF tender in Q2/Q3, for GDF QA
criteria GDF will limit procurement to suppliers
under Option I where there 2 or more suppliers
under this option
Implications for GFATM PRs
• For more information on TB Prequalification, please refer to
the Global Drug Facility web-site:
www.stoptb.org/GDF or the WHO website at
www.who.int /medicines
Or contact, via electronic mail:
[email protected]
[email protected]
[email protected]
Contact Information
General QA Information for TB
• Careful Product Selection
– Safe, effective, quality medicines as evidenced by
clinical trials, reference literature
– Dosage forms that have longer shelf life
– Properly packaged products
Actions to Obtain Good-Quality
(TB) Products (1)
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
• 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
Actions to Obtain Good-Quality
Tuberculosis Products (3)
• Bidding Document Specifications for
Fixed-Dose 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
Actions to Obtain Good-Quality
Tuberculosis Products (4)
• Product Certification
– Obtain GMP certificate from drug regulatory authority,
UNIPAC, or other international agency
– Obtain WHO-type certificate from drug control agency
of exporting country
Actions to Obtain Good-Quality (TB)
Products (5)
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
– Request GMP or WHO-type certificates
for imported drugs
• Contract Specifications
– Pharmacopeia 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
Actions to Obtain Good-Quality (TB)
Products (7)
• Physical inspection of each shipment:
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packing list / quantities, batch numbers,
Packing intact
Presentation of drugs: color, smell etc
Shelf life
• Laboratory testing:
– standardized or random sampling
– Pharmacopoeia
– Sterility for injectables
Actions to Verify the Quality
of Shipped Medicines
• Product problem reporting system
indicates:
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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 (1)
• Product recall system allows quick
response
– Inventory system tracks batch to facility level,
classifies type of recall, monitors the recall
Actions to Monitor Product
Quality (2)
Summary
• Please make provision in proposals to GFATM or
reprogramming of approved proposals to improve
quality assurance:
– Identify gaps, select items to address short term / medium
term
• Ensure PRs adhere to GFATM compliance list
• In general advise procurement from Quality Assured
sources only:
– WHO List, GDF, GLC, GFATM List, MSF, UNICEF, IDA