1. GMP (Good Manufacturing Practices) can be defined as a package of requirements and procedures by which the work methodology takes place under controlled conditions and by which surrounding conditions are created that allow the production of hygienic and safe products.

2. A. Location and surrounding area In the design phase of processing areas, several aspects are of particular concern with regard to hygiene. These may include: 1> proximity of potential sources of contamination; 2>sufficiency and quality of water supply; 3>wastewater removal; 4> adequacy of power supply; 5> availability of transport. 6>Climate can have an important influence on design criteria.

3. B.The Building ( 1).Arrangement of rooms, areas and processes within establishments Receipt, identification, sampling, and quarantine of incoming materials, pending release or rejection; − Quarantine before release or rejection of intermediates and APIs; − Sampling of intermediates and APIs; − Holding rejected materials before further disposition (e.g., return, reprocessing or destruction); − Storage of released materials; − Production operations; − Packaging and labelling operations; and − Laboratory operations.

4. 1...Floors constructed with waterproof, non-absorbent, washable material without fissures or crevices. Floors made from stone, asphalt or tiles are suitable, particularly in rooms where the floor is constantly wet or washed frequently. Angles between floors and walls or floors and bases of columns should be sealed and coved. 2...Walls Walls should have coverings of impervious, washable material or be constructed of material coated with an impermeable varnish up to a certain height. 3...Windows The window openings must be sealed so as to avoid accumulation of dust and dirt. 4...Doors Doors must be tight fitting. should have smooth,non-absorbent surfaces..

5. 1...Lighting. Lighting can be natural or artificial and may not alter colours significantly. Following intensities are recommended: global light intensity : 400 lux at inspection points : 600 lux in storage depots : 250 lux.

6. 1...Clothes changing facilities Each company is obliged to have a specific room for changing normal clothing to work clothing. Clothes changing facilities should be clean and neat and may not be used as refectory or smoking room The cupboards must have a part for normal clothing and one for work clothing. There should be a separate rack for cleaned work clothing.

7. 2...Hand washing facilities Hands are often contaminated by contact with raw materials carrying pathogenic or spoilage organisms. Furthermore, people working in food operating areas may often be unwitting carriers or excretory of Salmonella or other infectious organisms. Hand washing facilities must provide cold and hot flowing water or premixed water at a specific temperature, a reservoir of washing and decontamination products for the hands. 3... Adequate ventilation, air filtration and exhaust systems should be provided, 4... Water used in the manufacture of APIs should be demonstrated to be suitable for its intended use

8. Thank You