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)

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

• 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 (3)

Actions to Obtain Good-Quality Tuberculosis Products (4)

• 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

• Specify what YOU want/need!

4-FDC (RHZE)R: molecular size & structure of API R: degrades in daylightR+H: interact (humidity!)HPLC peak of impurities can be hidden by R peakE: is highly hygroscopic: --- Coated tabletsDark 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

• Contract Specifications 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 Obtain Good-Quality (TB) Products (7)

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-outInclude necessary actions in

your PMS plan!

2. Sample Quality requirements in tender letter

Management Challenge

Buyer

Be

AWARE!