- Review measures to ensure Good Sanitation in:
- Premises and Personnel
- Equipment and Apparatus
- Processes, Materials and Containers
2. To review measures to ensure Good Personal Hygiene
High level of Sanitation and Hygiene practiced – in every aspect of Manufacturing. It covers:
- Equipment and Apparatus
- Production Materials and Containers
- Products for cleaning and disinfection
- All potential sources of cross-contamination
General points to be Followed :
- Take daily bath
- Cut nails and comb hair neatly
- Use hair covers in all areas (Cap, beard cover, etc.)
- Do not keep open wounds
- Person having contagious diseases should avoid contact with other persons and product.
- Follow the Entry and Exit SOPs strictly while entering in each area
- Gowning of personnel shall be followed to maintain departmental hygiene
- Ornaments, Make up, Watches, Perfumes and other Chemicals shall not be used in Production Facility
Basic Principles of GMP :
- Written procedures and instructions and signs – e.g. to wash hands before entering Production Areas .
- Disinfectants are also used e.g. IPA, Sterilium.
- Wash hands before entering Production Areas.
- Toilets should not open directly into Production or Storage Areas.
- Wash hands after each usage of Toilet
Personal Hygiene :
- Health Examinations :
- Before joining and during employment periodically
- After long illness
2. Training :
- Practices in personal hygiene
- Written procedures and instructions
- Signs and captions in areas
3. 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
4. Direct contact between Product and Operator :
- Should be avoided
- Starting Materials, Primary Packaging Materials, Intermediate and Bulk Product
5. Protection of product from contamination:
- Clean clothes appropriate to personnel activities
- Including hair covering (e.g. Caps, Beard Covers)
6. Check 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
- 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.
7. Personal hygiene procedures including wearing protective clothing apply to all persons entering into production areas:
- Full-time employees
- Temporary workers
- Contractor’s employees