SANITATION & HYGIENE

1. SANITATION & HYGIENE KHADIJAH ADE-ABOLADEMPH. FPCPharm. Chief Regulatory Officer/Lead Inspector Drug Evaluation & Research NAFDAC

2. OBJECTIVES • Understand the requirements for sanitation and hygiene in pharmaceutical manufacturing • Personnel • Premises • Operations • Identify measures to ensure sanitation and hygiene in pharmaceutical manufacturing

3. OUTLINE • Regulatory requirements • Personnel Hygiene • Design of Premises • Operations • Procedures • Avoidance of cross-contamination • Waste Disposal • Conclusion

4. Regulatory Requirements NAFDAC CGMP for Medicinal Products Regulations 2009 Sections: • 7a, 7b, 7d • 12g • 14b • 15a, 15b, 15c • 16b, 16c • 17a

5. Scope of Sanitation & Hygiene High level of sanitation and hygiene practised – in every aspect of manufacturing. • Personnel - direct operators and other staff • Premises - vary with the operation • Equipment and apparatus • Production materials and containers • Materials for cleaning and disinfection • All potential sources of cross-contamination

6. Personnel Hygiene • Health examinations: • Before and during employment • Periodic eye examinations - for those who do visual inspections • Training: • Practices in personal hygiene • Written procedures and instructions – hand washing, disinfection etc. • Signs in areas to reinforce procedures

8. Personnel Hygiene • Illness or open lesions: • May affect the quality of products • Should not handle starting materials, intermediates or finished products, etc. • Instruction and encouragement to report to supervisors • Direct contact between product and operator: • Should be avoided • Starting materials, primary packaging materials, intermediate and bulk product

9. Personnel Hygiene • Protection of product from contamination: • Clean clothes appropriate to personnel activities • Including hair covering (e.g. caps) • Change rooms/changing facilities • Hand washing, signs, drying of hands • Used clothing stored in separate closed containers while awaiting cleaning • Laundering of clean area clothing according to an SOP and in an appropriate facility • Procedure for disinfecting and sterilizing when required

10. Personnel Hygiene • Personnel hygiene procedures including wearing protective clothing apply to all persons entering into production areas: • Full-time employees • Temporary workers • Contractor's employees • Visitors • Managers • Inspectors

11. Personnel Hygiene • Protection of operator and product • Special protective clothing for highly potent products • Personnel movement between areas producing different products • Garment cleaning • Use of gloves

12. Personnel Hygiene • Smoking, eating and drinking not allowed in production areas, laboratories and storage areas • No chewing (e.g. gum), or keeping food or drinks allowed • No plants kept inside these areas • Rest and refreshment areas should be separate from manufacturing and control areas

13. Design of Premises • Depends on the activities • Must prevent the build-up of dirt and dust

14. Design of Premises • Layout and design • minimize the risk of errors • permit effective cleaning and maintenance in order to avoid cross-contamination • build-up of dust or dirt • any adverse effect on the quality of products.

15. Design of Premises • Walls, floors, ceilings, ledges, drains, air supply, dust extraction • Cleaning programme, appropriate cleaning, cleaning records • Effective cleaning and disinfection • choice of materials and chemicals, validation

16. Toilets should not open directly into production or storage areas

17. Design of Premises • Should certainly not be located in sterile areas • Their design must prevent the possibility of back-flow • While drains are inevitable in some manufacturing areas, they should be kept to a minimum

18. Design of Premises • Premises should be designed and equipped so as to afford maximum protection against the entry of insects, birds, vermin or other animals; and weather. There should be a procedure for rodent and pest control. • From receipt of raw materials to dispatch of released product.

19. Design of Premises • Installation of a ventilation system that provides an appropriate flow of air. • Filtered incoming air • Pressure differentials and air extraction • Airlocks

20. Operations • Cleaning and cleaning validation • Degree of cleaning depends on whether consecutive batches are of same or different product • Cleaning agent is fully removed • If possible hot water alone used for cleaning • All cleaning and disinfecting solutions carefully prepared and expiry dated • Final rinse with purified water, or water for injection (for sterile products) • Full records kept

21. Operations • Water systems • SOP for cleaning and sanitization of the water purification system should include distribution line • Validation and removal of disinfectant before reuse

22. Operations • Maintenance and repair • Activities inevitable in manufacturing area • Should present no risk to product • Whenever possible, all planned maintenance outside normal operating hours • Emergency work in working area followed by thorough clean down and disinfection before manufacturing recommences • Area clearance by QC

23. Written Procedures • Assigning responsibility for sanitation • Describing in sufficient detail the cleaning schedules & methods • Equipment and materials to be used • Control of the materials and tools • Suitable pesticides, fumigating, cleaning and sanitizing agents.

24. Avoidance of contamination & cross-contamination • Ventilation systems & Airlocks • Segregated areas /dedicated and self contained facilities • Closed processing systems • Cleaning and decontamination • Special precautions to prevent generation and dissemination of dust • Campaign production • Clothing

25. Waste Disposal • Hazardous waste • In a timely and sanitary manner • According to written procedures

26. CONCLUSION • Sanitation & hygiene requirements apply to all aspects of pharmaceutical manufacturing. • Benefits and importance of sanitation & hygiene in pharmaceutical manufacturing cannot be over-emphasized in order to assure quality of the products

27. References • NAFDAC cGMP for Medicinal Products Regulations 2009 • WHO GMP Training Modules • WHO TRS 986 Annex 2; Good manufacturing practices for pharmaceutical products: Main principles

28. THANK YOU

29. QUESTIONS?