cGMP.pptx

cGMP refers to Current Good Manufacturing Practices (CGMP) regulations enforced by US FDA .
CGMP are the methods to be used in ,the facilities or controls to be used for ,the manufacturing ,processing, packaging or holding of a drug to assure that such drug meets
The requirements of the act, and has the identity and strength and meets the quality and purity characteristics that is represented to possess.

1. Objective and policies of c GMP, layout of buildings and services Submitted By : Shiva Kant Thakur M. Pharm 1 st year ( pharmaceutics ) Submitted To : Dr . Himmat Singh Chawda Modern Pharmaceutics M . Pharma Pharmaceutics

2. GMP cGMP Importance of cGMP Objective of cGMP Policy of cGMP Layout of buildings , services and equipment CONTENTS

3. Good manufacturing practice. That part of quality assure which ensure that the products are consistently produced and controlled . The quality standards appropriate to their intended use and as required by marketing authorization . GMP

4. cGMP refers to Current Good Manufacturing Practices (CGMP) regulations enforced by US FDA . CGMP are the methods to be used in ,the facilities or controls to be used for ,the manufacturing ,processing, packaging or holding of a drug to assure that such drug meets The requirements of the act, and has the identity and strength and meets the quality and purity characteristics that is represented to possess. cGMP

5. OBJECTIVES Ensure that products are consistently manufactured and controlled to the specified quality. Concerned with all aspects of production and quality control. In the manufacture of cosmetic products, overall control and monitoring is required. Ensure that the consumer receives products of specified quality.

6. PLANT LAYOUT STORE LAYOUT LAYOUT OF BUILDINGS

7. Plant layout is a coordinated effort to achieve the final objective to integrate machines, materials , and personnel for economic production. Involves location of different departments and arrangement of machinery in each department. 1.PLANT LAYOUT

8. Process layout or functional layout Arrangement of machines of a particular class doing a particular process as separate department . Advantages : More effective supervision Division of labour can be provided . Disadvantage : May not be possible as a number of unit operations have to be performed. TYPES OF PLANT LAYOUT

9. Product or straight line layout: The arrangement of machines doing various operations in a line as one department. Advantages: Processing of work is quick and smooth . Cost of handling is reduced using conveyers. Manufacturing time can be reduced . Floor space can be properly utilized. CONTINUE…..

10. Basic managerial policies and decisions. Nature of plant location. Type of industry and process intermittent industries Continuous industries Types of methods of production Job production Batch or lot production Continuous or mass production FACTOR INFLUENCING PLANT LAYOUT

11. Should be planned in the objectives of : Achieving minimum wastage of spaces Achieving maximum ease of operations The layouts should : Make optimum utilization of floor space and height , Should be ventilated. Should be 1.5-3m wide to facilitate traffic. Permit effective and orderly segregation of various categories of materials and allow rotation of stock. protected from waste, damage and deterioration. Have provisions for storage as per specific conditions. STORE LAYOUT

12. STORE LAYOUT

13. Lighting : Adequate lighting shall be provide in all areas. Ventilation ,air filtration, air heating and cooling. Equipment for adequate control over air pressure , micro-organisms , dust , humidity , and temperature shall be provided appropriate for the manufacture , processing , packing ,or holding of a drug product . Air filtration system, including prefilters and particulate matter air filters , shall be used appropriate on air supplies to production areas. Adequate ventilation shall be provided. SERVICES

14. Plumbing Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any drug product.Potable water shall meet the standards as prescribed. Sewage and refuse Sewage, trash ,and other refuse from the building and premises shall be disposed of in a safe and sanitary manner. SERVICES

15. Washing and toilet facilities Adequate washing facilities shall be provide ,including hot and cold water ,soap or detergent , air drier or single –service towels , and clean toilet facilities easily accessible to working areas. SERVICES :

16. Manufacture ,processing ,packing , or holding of a drug shall be maintained in a clean and sanitary condition . Any such building shall be free of infestation by rodents, birds , insects , and other vermin. Trash and organic waste matter shall be held and disposed of in a timely and sanitary manner. Sanitation procedures shall apply to work performed by contractors or temporary employees as well as work performed by full-time employees during the ordinary course of operations . SANITATION

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