Good Manufacturing Practice in Animal Cell Culture.pptx

Good Manufacturing Practice

1. Good Manufacturing Practice

2. Introduction to GMP GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risk involved in the production of any food and beverages, cosmetics, pharmaceutical products ,   dietary supplements, and  medical devices production that can not be eliminated through testing the final product. GMP is now designated as cGMP due to the constant evolving nature of GMP

3. GMP covers all aspects of production from the starting material, premises and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process- every time a product is made. Introduction to GMP

4. Principles of GMP Written Procedures Following Procedures Documentation Validating Work Facilities and Equipment Maintenance Job Competence Avoiding Contamination Quality Control Audits

5. Documentation in cGMP

6. cGMP in Cell Culture Much of the general information regarding conventional or classical manufacture of pharmaceuticals applies to cell culture manufacturing but extra guidance is considered necessary for this highly specialized and relatively new discipline in manufacturing. The variability in all of these living organisms and the potential for contamination with other organisms necessitates extremely stringent controls to protect the integrity of the product and in some cases, to ensure the safety of operators and the surrounding environment.

7. Special Considerations of cGMP in Cell Culture Master Cell Banks – Working Cell Banks Personnel Premises and Equipment Quality Control

8. Cell Bank All production cultures used to manufacture drug product must be initiated from a reserve stock of well-characterized cells, more commonly referred to as a cell bank. Cell banks and seed stocks must go through full characterization and safety testing. It is critical that there is no significant contamination or instability in this material. Stored cells and seed stock is split and maintained at different locations to minimize the chances of total loss. They should be stored with suitable labelling and auditable evidence of their movement, storage conditions and access records.

9. Personnel The standard of training for staff in the biological manufacturing environment must be of the highest order People working with cell culture processes must receive training additional to that required for ‘normal’ pharmaceutical manufacture Procedural controls, personal hygiene and health of manufacturing personnel are of great importance in cGMP of cell culture

10. Premises and Equipment The design and control of premises suitable for cell culture manufacture of pharmaceuticals is a massive subject Consideration should be given to the design and construction of the building, facilities and equipment All utilities that could impact on product quality such as water, compressed air, steam, heating, ventilation and air-conditioning, should be qualified and monitored Both equipment and facilities should have specific maintenance and cleaning schedules outlined as part of an ongoing programme There should be sufficient space within the facility, and the process flow should be designed in such a way, as to avoid mix-ups, and contact between product or starting materials and waste

11. Quality Control Testing to ensure- identity quantity purity impurity potency Sterility including adventitious agents The tests employed in final QC analysis should be validated A certificate of analysis would be produced and approved by relevant personnel within the organization

12. cGMP and Quality Assurance