Quality Control Principles Challenges in Veterinary Biopharmaceuticals

1. Quality Control Principles & Challenges in Veterinary Biopharmaceuticals Qurban Ali PhD

2. �Quality� No more a choice but first and foremost requirement of users; that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization or product specification

3. �Assuring Quality� Good Manufacturing Practices (GMP) are applied in both �production and quality control�

4. GMP � What is needed ? all manufacturing processes are clearly defined, systematically reviewed consistently producing required quality specifications critical steps of manufacturing processes and significant changes to the process are validated; all necessary facilities for GMP are provided including: a. appropriately qualified and trained personnel; b. adequate premises and space; c. suitable equipment and services; d. correct materials, containers and labels; e. approved procedures and instructions; f. suitable storage and transport;

5. Operational Components

6. Maintaining Quality Guiding Principle Consistency in achieving specifications and quality product Application Covers entire chain of premises, materials, processing, testing, storage and release Self inspection Independent quality checks Regulatory agencies inspections Reports and follow-up actions Complaints & investigations Continued R & D

7. Veterinary Biopharmaceuticals

8. Manufacture of biological medicinal products Biological medicinal products may include: vaccines, sera, antigens, hormones, cytokines, enzymes and other products of fermentation (including monoclonal antibodies and products derived from DNA/RNA) Involves certain specific considerations arising from the nature of the products and the processes Unlike conventional medicinal products, use of chemical and physical techniques which are capable of a high degree of consistency Biological processes, materials, biological analytical techniques have a greater variability than physico-chemical determinations The special properties of biological medicinal products require careful consideration in any code of Good Manufacturing Practice especially in-process controls

9. What is needed? Finished products of highest purity, safety, potency and efficacy possible

10. Pakistan � Drug Control Scenario Controlled under DRUG ACT, 1976 An act to regulate the import, export , manufacture, storage, distribution and sale of drugs including vaccines Extends to whole Pakistan Offence under the act can be investigated by Police Officer either upon his own information or drug inspector Contains detailed guidelines on GMP Current GMP guidelines revised in the light of SIX functions of WHO in the member countries

11. Veterinary Vaccines � Pakistan Challenges in Keeping Quality Priority Lack of priority within current control authority Premises Does not meet to the minimum requirements of cGMP especially in public sector Plan Since root back to general diagnostic work infrastructure, does not full-fill need Personnel Relevance and level of training remain questionable in both public and private sector

12. Challenges in Keeping Quality Raw material No in-coming quality control of materials in place or it is erratic Equipment Dedicated, suite to need, and appropriate nature is needed to be looked at Processing Lack of control in processes at critical stages

13. Challenges in Keeping Quality Quality Control As such it needs to be established through �instituting quality culture� & �legal framework� Product Continuous R&D, diversity in products very much needed Storage & Transport To be considered carefully at all levels from manufacturers to supplies and users

14. Way Forward Building Capacity Awareness Investments Training and expertise Leadership Dedicated, independent �in process� quality management at production level

15. Way Forward Instituting an �Optimal� quality assurance system Addressing production and final product testing in proper balance Designing and implementing control procedures best-fit to local conditions and realities Obtaining voluntary compliance with established regulatory authority � yet keeping authority

16. Way Forward Defining Control/ Quality Standards Process Standards in comparison with control testing of the final products i.e Performance Standards Legal framework Moderate, development oriented, assigning control to relevant and enforcement system with-in current set-up keeping in view the cost-consumer relation

17. Biologics = Miracles +Tragedies + Speed bumps 13 children in St. Luice died of Tetanus after receiving diphtheria antitoxin from horse named Jim This tragedy convinced Congress and the public that producing antitoxin of vaccine was not a simple matter like weighing out a dose of a drug on a scale� Margaret Pittman. �The regulation of biological products 1902-1970�

18. Thank you for Your attention