2. Acknowledgment
Material for this session is adapted from Chapter 18,
“Quality Assurance for Drug Procurement,” of
Managing Drug Supply 2nd ed. Management
Sciences for Health and World Health
Organization, 1997.
3. Objectives
Define medicine quality
Understand how medicine quality is
assessed
Understand how medicine quality is
ensured
Describe the role of the DTC in
pharmaceutical quality assurance
4. Outline
Key definitions
Introduction
Determinants of medicine quality
How is quality assessed?
How is quality assured?
Important pharmaceutical quality issues
for the DTC
Implications for the DTC
5. Key Definitions (1)
Pharmaceutical quality assurance (QA)—Sum of
all activities and responsibilities required to ensure that
the medicine that reaches the patient is safe, effective,
and acceptable to the patient
Pharmaceutical quality control—Process
concerned with medicine sampling, specifications, and
testing, and with the organization’s release procedures
that ensure that the necessary tests are carried out and
that the materials are not released for use, nor products
released for sale or supply, until their quality has been
judged satisfactory
6. Key Definitions (2)
Good Manufacturing Practices (GMP)—
Performance standards that WHO and many national
governments established for pharmaceutical
manufacturers covering, for example, personnel,
facilities, packaging, and quality control.
GMPs are part of the quality assurance activities that
ensure that products are consistently produced and
controlled to the quality standards appropriate to their
intended use and required by the drug regulatory
authorities.
7. Introduction: Goals of Medicine QA
Programs
To make certain that each medicine reaching a
patient is safe, effective, and of standard
quality
Obtaining quality products that are safe and
effective through structured selection and
procurement methods
Maintaining quality products through the
appropriate storage, distribution, monitoring, and
use by prescribers, dispensers, and consumers
8. Characteristics of a Comprehensive
QA Program (1)
Medicines are selected on the basis of safety and
efficacy, in an appropriate dosage form with the
longest shelf life
Suppliers with acceptable quality standards are
selected
Medicines received from suppliers and donors are
monitored to meet quality standards
Medicine packaging meets contract specifications
9. Characteristics of a Comprehensive
QA Program (2)
Repackaging activities and dispensing practices
maintain quality
Adequate storage conditions in all pharmaceutical
areas are maintained
Transportation conditions are adequate
Product quality concerns are reported and
monitored
10. Impacts of Low-Quality Medicines
?
MEDICINE
QUALITY
Manufacturing
process
Packaging
Transportation
Storage
condition
Lack of therapeutic
effect:
Prolonged illness
Death
Toxic and adverse
reaction
Waste of limited
financial resources
Loss of credibility
11. Determinants of Medicine Quality
Identity: Active ingredient
Purity: Not contaminated with potentially harmful
substances
Potency: Usually 90–110% of the labeled amount
Uniformity: Consistency of color, shape, size
Bioavailability: Interchangeable products?
Stability: Ensuring medicine activity for stated period
Identity, purity, potency, uniformity are defined in pharmacopoeias
and stated in certificate of analysis (COA)
18. Medicines with a Stability Problem
Tablets:
Acetylsalicylic
acid
Amoxicillin
Ampicillin
Penicillin V
Retinol
Oral liquids:
Paracetamol
Injectable:
Ergometrine
Methylergometrine
Select the most stable formulation with adequate packaging
19. How Is Quality Assessed?
INSPECTION of products on
arrival
Visual inspection
Product specification review
(including expiration dates)
LABORATORY TESTING for
compliance with pharmacopoeial
standards
International Pharmacopoeia
European Pharmacopoeia
U. S. Pharmacopeia
British Pharmacopoeia
National Pharmacopoeia
BIOAVAILABILITY DATA
COA
11
33 22
20. How Is Medicine Quality Assured? (1)
Product selection
Long shelf-life
Acceptable stability
Acceptable bioavailability
Selection of appropriate suppliers
Supplier pre-qualification
Request samples from new suppliers
Request specific reports and data for certain medicines
(e.g., bioavailability and stability studies)
Collect and maintain information on supplier performance
Product certification
GMP certificate of manufacturer
Product/batch certification (COA)
Random local testing
21. How Is Medicine Quality Assured? (2)
Contract and procurement specifications
Pharmacopeia reference standard
Local language for product label
Standards for packaging to meet specific
storage and transport conditions
22. How Is Medicine Quality Assured? (3)
Appropriate storage, transport, dispensing, and
use procedures
Pharmaceutical distribution and inventory control
procedures
Provision for appropriate storage and transport
including adequate temperature control, security,
and cleanliness
Explicit enforcement of cold chain procedures
Appropriate dispensing: containers, labeling,
counseling
Avoidance of repacking unless quality control in
place
23. How Is Medicine Quality Assured? (4)
Product monitoring system
Problem reporting: who, how, where,
and to whom; what additional
measures; what follow-up information
Product recalls: hospital or country level
24. Who Ensures Medicine Quality?
Drug
regulatory
authority
Medicine
Quality
Physicians
and other
prescribers
Drug and
Therapeutics
Committee
Hospital
procurement
office
Pharmacy
(and dispensers)
Patients
25. Implications of Pharmaceutical QA for the DTC
Providing technical advice on procurement of
pharmaceuticals
Defining product specifications
Generic medicines
Bioavailability issues
Stability issues
Defining minimum laboratory testing
Providing technical advice to hospital departments
Medicine transportation and storage
Dispensing
Analyzing product problem reports
Quality complaints
Medicine recall system
26. Activity (30 minutes)
Pharmaceutical quality assurance issues and
concerns on—
Obtaining quality products
Maintaining quality products
Examples of poor quality
Discussion
at hospital level
Are you satisfied with the quality of medicines you receive?
Is quality maintained throughout your distribution network?
Are there complaints of poor quality by patients or health
workers?
Is there a formal mechanism for reporting and investigating
complaints?
What role do you see for the DTC in improving and
maintaining quality in your health care system?
27. Summary (1)
Ensuring quality of a product from selection to
use—
Obtaining quality products that are safe and
effective through structured selection and
procurement methods
Maintaining quality products through
appropriate storage, distribution, monitoring,
and use methods
28. Summary (2)
Assessing quality includes—
Inspection of medicines
Laboratory testing when necessary
29. Summary (3)
Assuring quality includes—
Selection of medicines, dosage forms, and
packaging
Use of prequalified suppliers
Product certification
Preparation and enforcement of quality-related
contract specification
Appropriate storage, transport, dispensing, and
use
Product monitoring systems