Objectives :

1. 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

Scope :

High level of Sanitation and Hygiene practiced – in every aspect of  Manufacturing.  It covers:

• Personnel
• Premises
• 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 :

1. Written procedures and instructions and signs – e.g. to wash hands before entering Production Areas .
2. Disinfectants are also used e.g. IPA, Sterilium.
3. Wash hands before entering Production Areas.
4. Toilets should not open directly into Production or Storage Areas.
5. Wash hands after each usage of Toilet

Personal Hygiene :

1. 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
• Visitors
• Managers
• Inspectors

• Uncategorized