2. QUALITY ASSURANCE OF PHARMACEUTICAL PRODUCTS IN RMH
RUTIKANGA U. Flavia
B.Pharm

3. PRESENTATION CONTENTS
1.INTRODUCTION 2.OBJECTIVES 3.DETERMINANTS OF PHARMACEUTICAL QUALITY 4.PRACTICAL APPROACHES TO QUALITY ASSURANCE 5.PHARMACEUTICAL QUALITY ASSURANCE 6.MONITORING PHARMACEUTICAL QUALITY ASSURANCE 7. CONSEQUENCES OF POOR PHARMACEUTICAL QUALITY ASSURANCE 8. PERSONNEL AND TRAINING IN QUALITY ASSURANCE OF PHARMACEUTICAL PRODUCTS 9. CONCLUSION 10.RECOMMANDATIONS

4. 1.INTRODUCTION
The Quality assurance in pharmaceutical supply systems is to help ensure that each medicine reaching a patient is safe, effective and of acceptable quality.
In Rwanda, PTF (Pharmacy Task Force)/MOH has the responsibility to assure the quality of all drugs and medical devises which enter our country.
They have the administrative quality assurance through Registration program,visa,license that they give the wholesale pharmacies or the suppliers of private pharmacy ,others and quality control of the pharmaceutical products at LABOPHAR, and some Belgium Drug Control Analysis laboratories.
We have the New National Drug control Analysis Laboratory which will comply the EAC standards.
Safe:
Effective:
Acceptable Quality:
Visa:
Licence:

5. 2. OBJECTIVES
To better understand the role of Drug Therapeutic Committee in Quality Assurance of Pharmaceutical Products in our hospital (for Doctors, pharmacists, nurses ,other health professional, administrative and financial staffs)
To understand, apply policies and procedures of pharmacy directorate; develop more standards and procedures of the dispensing, sub-pharmacies and clinical pharmacy.

6. 3.DETERMINANTS OF PHARMACEUTICAL QUALITY
Start with:
Materials
Plant environment
Manufacturing equipment
Technical of developing
Manufacturing the pharmaceutical
Packaging
Transportation
Storage Conditions

8. a. QUALITY CONTROL OF PHARMACEUTICAL PRODUCTS
In the Laboratory of Pharmaceutical Quality Control, the drug is analyzed to identify:
Identity
Purity
Strength or potency (dose)
Uniformity of dosage form
Bioavailability
Stability

9. b. QUALITY ASSURANCE OF PHARMACEUTICAL PRODUCTS
In Rwanda Military Hospital, we use physical control to assure the quality of the selected, procured and received :
Physical Control :
Compare the supplier contract list of pharmaceutical products specification vis Purchase order vis Deliver Note
Physical state of the pharmaceutical products (Packaging presentation, Notice, Name, Dose, Formulation)
Bottle, Jar, Tablets, Capsules, Blister…….
Expired date which have to be 2 years when we receive the product
Pharmacovigilance System: We have not yet begin to use this method.

10. 4.PRACTICAL APPROACHES TO QUALITY ASSURANCE
Procedures to ensure that only medicine products that meet current standards for quality are bought by:
Careful product selection
Careful supplier selection through Procurement procedures
Inclusion of detailed product-quality specifications in the contract terms of the supplier
Careful Reception of the pharmaceutical items
Store in the good conditions of the storage
Distribution and ensure the transportation
Use of the drugs with the instructions

12. SUPPLY CHAIN CYCLE OF PHARMACEUTICAL PRODUCTS
SELECTION
QUANTIFICATION
PROCUREMENT
RECEIPT
STORAGE
DISTRIBUTION
USE

14. 5.PHARMACEUTICAL QUALITY ASSURANCE
In RMH, Quality Assurance of pharmaceutical products is ensured by the selection, procurement ,reception, distribution and use of pharmaceutical items.
Selection is based on the previous list of pharmaceutical items and other information like morbidity or consumption. Normal the pharmaceutical lists of items should be selected based on pharmaceutical quality assurance framework .
Procurement is based on the right drugs, in the right quantities at a lowest possible total cost, selection rely to suppliers of quality products through procurement method and contract terms (ensure timely delivery and other terms)

15. a. Pharmaceutical quality assurance framework
Five elements that are critical to achieve the expected treatment outcome.
1. Active pharmaceutical Ingredient has been shown to be safe& effective for the treatment
2.Product is of suitable quality to provide an effective outcome
3.Prescriber has accurately identified the need for the treatment
4.Prescriber or dispenser has properly instructed the patient on how to use the product
5.Patient complies with the prescribed regimen correctly

16. 5.PHARMACEUTICAL QUALITY ASSURANCE
Reception of the pharmaceutical items is based on physical control using eyes or physical analysis control ( Expired date, Name of product or non-proprietary name or generic name if it is the same as in the specification written in the purchase order, dosage of the drugs, and the formulation)
We have the Reception committees of 10 members (to the doctor as a chairperson, secretary and other members)
This committee assure the quality of received pharmaceutical products as they look on physical conditions, expired date of every received product to be one and half year or two of the receiving time;and compare if the purchase ordered item specification is the same as delivered note.
After counting and receiving all the items , they make the pharmaceutical quality reception report for a good management.

17. Continue……
RECEPTION
Quality Control: Drugs Analysis (Quality Control and Quantity Control) of every received item at LABOPHAR. They perform 60% and other 40% sent to the Drug Analysis Laboratory in Belgium. Rwanda launched last few months ago The National DRUG Quality Controls.

18. Continue…. Quality Assurance: RECEPTION Reception committee
Delivery report
Purchase Order
Invoice
Reception report
RECEPTION

19. 5.PHARMACEUTICAL QUALITY ASSURANCE
Storage , the pharmaceutical products are stored in :
Secure area (which avoid contamination or deterioration, disfiguration of labels, maintain the integrity of packaging, potency of drugs during shelf-life, prevent losses, and infestations of pests….)
Storage Environment (Clean conditions, Appropriate Shelves, Sufficient light, adequate temperature, and cold storage facilities )
Arrangement of drugs on shelves : shelves are made of steel ,strong and robust and drugs are arranged in therapeutically class and in FEFO or FIFO

20. 5.PHARMACEUTICAL QUALITY ASSURANCE
Distribution, the pharmacy distribute the drugs to different units of the pharmacy, the storage and transport are secured!
Use of pharmaceutical products, we have the clinical pharmacist who continue to assure the quality of pharmaceutical products use according to the following:
Appropriate dose
Appropriate dosage form
Appropriate route of administration
Appropriate frequency of administration
Appropriate duration of treatment
Appropriate information
Adequate follow up

21. 6.MONITORING PHARMACEUTICAL QUALITY ASSURANCE
Product problem reporting system
We have in our country the national product problem reporting system which is in Pharmacy task force and they call it
“ PHARMACOVIGILANCE SYSTEM”: which includes monitoring and reporting adverse drug events and medications errors.
Pharmacovigilance: is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

22. 7. CONSEQUENCES OF POOR PHARMACEUTICAL QUALITY ASSURANCE
Clinical effects:
Lack of therapeutically effect may lead to prolonged illness or death
May induce toxic or adverse reactions
Economic effects:
Wastes money
May seriously affect health system credibility

23. 8. PERSONNEL AND CPD IN QUALITY ASSURANCE OF PHARMACEUTICAL PRODUCTS
Quality assurance is a widely shared responsibility for the pharmacists, pharmacy technicians, assistants pharmacist, doctors, nurses, and all other health cares.
Our Directorate ,have already begin to give CPD session to the staffs about Quality Assurance and we will also continue to prepare the different standards of practices to improve the quality.

24. 9. CONCLUSION
The Pharmacy Directorate have put in place policies and procedures of the supply chain management cycle which help all staffs to understand more our daily work in pharmaceutical quality assurance and management
Quality assurance of pharmaceutical products is a widely shared responsibility (Pharmacist, Doctors, nurses, procurement staffs, finance staffs, and all the health worker).
We, RMH staffs need to review and preserve pharmaceutical quality at all level.

25. 10. RECOMMANDATION
Pharmaceutical Management programs which will manage all possible quality assurance activitiesfor the products that are procured:
Drug Therapeutic Committee
Pharmacovigilance system
Antibiotics stewardship committee
Put in place standard of practices of dispensing pharmacy and sub-pharmacies
More CPD sessions about the objectives and utilities of pharmaceutical management programs and supply chain management of pharmaceutical products.

26. THANK YOU FOR YOUR ATTENTION