cGMP PRESENTATION [ Objectives ; Comparision ; Layout ]

OBJECTIVES OF cGMP.
LAYOUT
A: BUILDINGS
B: SERVICES
C: EQUIPMENTS
D: MAINTENANCE

1. PRESENTED BY – PATIL ABHISHEK SHARAD F. Y. M. PHARMACY DEPARTMENT OF PHARMACEUTICS 02-Aug-21 RAJARAMBAPU COLLEGE OF PHARMACY, SANGLI 1 cGMP O bjectives ; Comparision ; Layout

2. CONTENTS: 02-Aug-21 RAJARAMBAPU COLLEGE OF PHARMACY, SANGLI 2 OBJECTIVES OF cGMP. LAYOUT A: BUILDINGS B: SERVICES C: EQUIPMENTS D: MAINTENANCE

3. cGMP 02-Aug-21 RAJARAMBAPU COLLEGE OF PHARMACY, SANGLI 3 cGMP refers to Current Good Manufacturing Practice ( cGMP ) regulations enforced by US FDA. These 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.

4. Objectives: 02-Aug-21 RAJARAMBAPU COLLEGE OF PHARMACY, SANGLI 4 Ensure that products are consistently manufactured and controlled to the specified quality. Concerns with all aspects of production and quality control. In the manufacture of cosmetic products, overall control and monitoring. Ensure that the consumer receives products of specified quality. cGMP regulations assures the identity, strength, quality and purity of drug products.

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6. 02-Aug-21 RAJARAMBAPU COLLEGE OF PHARMACY, SANGLI 6 LAYOUT OF BUILDINGS :

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8. PLANT LAYOUT : 02-Aug-21 RAJARAMBAPU COLLEGE OF PHARMACY, SANGLI 8 Plant layout is 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.

9. TYPES OF PLANT LAYOUT: 02-Aug-21 RAJARAMBAPU COLLEGE OF PHARMACY, SANGLI 9 1. PROCESS LAYOUT / FUNCTIONAL LAYOUT : Arrangement of machines of a particular class doing a particular class doing a particular process as separate department . ADVANTAGE: More effective supervision. Division of labour can be provided. DISADVANTAGE : May not be possible as a number of unit operations have to be performed.

10. 02-Aug-21 RAJARAMBAPU COLLEGE OF PHARMACY, SANGLI 10 2. 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

11. FACTORS INFLUENCING PLANT LAYOUT: 02-Aug-21 RAJARAMBAPU COLLEGE OF PHARMACY, SANGLI 11 Basic managerial polices and decisions. Nature of plant locations. Type of industry and process 1. Intermittent Industries. 2. Continuous Industries. Types of methods of production 1. Job production. 2. Batch / Lot Production. 3. Continuous / Mass production.

12. LAYOUT OF STORES : 02-Aug-21 RAJARAMBAPU COLLEGE OF PHARMACY, SANGLI 12

13. 02-Aug-21 RAJARAMBAPU COLLEGE OF PHARMACY, SANGLI 13 Should be planned in the objectives of: Achieving minimum wastage of space. Achieving maximum ease of operations. The layouts should: Make optimum utilization of floor space and height. Should be 1.5- 3m wide to facilitate traffic Permit effective and orderly segregation of various categories of materials and allow rotation of stock (1st in 1st out) Should be ventilated Have provisions for storage as per specific conditions Adequately protected from waste, damage and deterioration.

14. SERVICES : 02-Aug-21 RAJARAMBAPU COLLEGE OF PHARMACY, SANGLI 14

15. 02-Aug-21 RAJARAMBAPU COLLEGE OF PHARMACY, SANGLI 15 Lighting : Adequate lighting shall be provided in all areas. Ventilation, air filtration, air heating and cooling:  Adequate ventilation shall be provided. 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 systems, including prefilters and particulate matter air filters, shall be used appropriate on air supplies to production areas.

16. 02-Aug-21 RAJARAMBAPU COLLEGE OF PHARMACY, SANGLI 16 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. Washing and toilet facilities : Adequate washing facilities shall be provided, including hot and cold water, soap or detergent, air driers or single-service towels, and clean toilet facilities easily accessible to working areas.

17. 02-Aug-21 RAJARAMBAPU COLLEGE OF PHARMACY, SANGLI 17 Sanitation :  Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a clean and sanitary condition, Any such building shall be free of infestation by rodents, birds, insects, and other vermin (other than laboratory animals). 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.

18. EQUIPMENTS & MAINTENANCE : 02-Aug-21 RAJARAMBAPU COLLEGE OF PHARMACY, SANGLI 18

19. 02-Aug-21 RAJARAMBAPU COLLEGE OF PHARMACY, SANGLI 19 Equipment should be designed and located to suit the production of the product. Design and Construction : The equipment surfaces coming into contact with any in-process material should not react with or adsorb the materials being processed. Equipment should not adversely affect the product through leaking valves, lubricant drips and through inappropriate modifications or adaptations. Equipment should be easily cleaned. Equipment used for flammable substances should be explosion proof .

20. 02-Aug-21 RAJARAMBAPU COLLEGE OF PHARMACY, SANGLI 20 Installation and Location: Equipment should be located to avoid congestion and should be properly identified to assure that products do not become admixed or confused with each another. Water, steam and pressure or vacuum lines, where applicable, should be installed so as to be easily accessible during all phases of operation. They should be clearly identified. Support systems such as heating, ventilation, air conditioning, water (such as potable, purified, distilled), steam, compressed air and gases (example nitrogen) should function as designed and identifiable.

21. 02-Aug-21 RAJARAMBAPU COLLEGE OF PHARMACY, SANGLI 21 Equipment cleaning and maintenance : Equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product. Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product.

22. 02-Aug-21 RAJARAMBAPU COLLEGE OF PHARMACY, SANGLI 22 REFERENCES : FDA “Guidance for Industry: Q7A Good Manufacturing Practice. Guidance for Active Pharmaceutical Ingredients,” Section 19. ICH Q7 Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients. Current step 4 version; November 2000 Website. Available from: http://www.ich.org/LOB/media/MEDIA433.pdf [Last cited on 2020 Jan 1].

23. 02-Aug-21 RAJARAMBAPU COLLEGE OF PHARMACY, SANGLI 23