QUALITY ASSURANCE CHALLENGES Presented by : SAID RASHID QUALITY ASSURANCE DEPARTMENT ZENUFA LABORATORIES LTD TANZANIA

INTRODUCTION ½ ….. Quality, Safety and Efficacy are the most important aspects of any pharmaceutical product. It is thus very important to check carefully all items and processes which will one way or another affect the quality, safety and efficacy of the finished pharmaceutical products. To ensure this QUALITY ASSURANCE is put in place and oversees all items and processes used in manufacturing of pharmaceutical products

INTRODUCTION 2/2 ……… Quality Assurance refers to the sum total of the organized arrangements set with the objective of ensuring that products manufactured will be of the quality required for their intended use.

Quality Assurance (QA) incorporates Good Manufacturing Practice (GMP) which further incorporates Quality Control (QC). It is the health of Quality Assurance which determines the Health of the finished pharmaceutical products.

QUALITY ASSURANCE CHALLENGES Quality Assurance face some challenges which in one way or another affect its effectiveness. Both major and minor challenges exist, and they include (but not limited to) :

1. High running and maintenance costs - References, Calibration services, revalidation services, machine repairs etc are mostly obtained from oversees, costs a lot of dollars and need instant payments - As a result Quality Assurance appears to be expensive and this may hinder its effectiveness

2. Shortage of trainings on better quality assurance There is required regular workshops, seminars, forums, courses and other forms of training on better and improved ways of quality assurance As a result of shortage of these trainings the department staffs may become less updated on new and better methods and equipment and improved Quality Assurance may take time to be effected

3. Shortage of good equipment - There is shortage of good equipment due to high costs of those equipment which can hardly be afforded on time by our developing industries. - This pose a block towards building good quality to the finished pharmaceutical products even if the good staffs are available

4. High costs of reference standards and materials This makes pharmaceutical industries fail to afford or afford and update them with difficulties They are also obtained from far, and take some time to be delivered This may slow QA activities or lead into the use of the outdated references while waiting for the new one to be purchased and delivered E.g. Pharmacopoeias

5. Shortage of competent personnel to work in Quality Assurance - The number of qualifying personnel willing to work in pharmaceutical industries is still very low. In addition to that most of them are deficient in Quality Assurance experience and are also more interested to work in hospitals, pharmaceutical marketing, NGOs and other fields - As a result recruiting and inducting a new personnel takes more time and after time they leave for other jobs

6. Poor adherence in handling and storage conditions by pharmacies and patients In case of poor adherence to the handling and storage conditions (Temperature, Humidity and Light) the quality of the medicines already in the markets is reduced This may contribute to the number of queries and complaints to manufacturers -> QA

7. Challenges from Suppliers Sometimes the suppliers of raw materials and packaging materials deviate from the agreements. They don’t give notification on time on changes happened in materials, manufacturers, sources of materials, manufacturing process, addresses etc This increases number of rejections and queries and consumes some of the precious time which could be used in other Quality Assurance activities

8. Adverse weather conditions along the zone Tropical belt adds to high temperatures and humidity, all of which may affect quality of medicines during and after manufacturing. This contributes to the high costs in maintaining production conditions, clean rooms and more preventive measures

9. Challenges in maintenance of good hygiene Due to low level of (pharmaceutical production) education of some workers, a lot of training and measures are needed to maintain a high level of hygiene Strict supervision and measures are required to maintain a high level of hygiene This takes time and efforts of the Quality Assurance department which could be used to maximize quality, safety and efficacy.

THANK YOU FOR YOUR ATTENTION….