1. SANITATION & HYGIENE KHADIJAH ADE-ABOLADE MPH. 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
While drains are inevitable in some manufacturing areas, they should be kept to a minimum
Should certainly not be located in sterile areas
Their design must prevent the possibility of back-flow

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?