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adesh01

Quality assurance

Chandrashekhar3
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adesh01

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  1. CHHATRAPATI SHIVAJI COLLEGE OF PHARMACY, Deori Subject- Pharmaceutical Quality Assurance Topic- premises[design,contruction and plant layout] Presented by- Adesh A. hatzade Class- 3rd year (6th semester) Guided by-Badwaik sir

  2. Premises Premises must be located, designed, Constructed and maintained to serve the Operations to be carried out efficiently It is a building used in manufacturing, processing, packaging or holding of drug product must be located, designed, Constructed properly to :- minimize the risk of errors. permit effective cleaning minimize the build up dirt and dust minimize the adverse effect on product Quality

  3. Ancillary areas: • Rest and refreshment rooms should be separated from manufacturing and control area • Toilets should not communicate directly with production or storage areas. • Maintenance workshops should if possible be separated from production areas. • Animal houses should not be close to the manufacturing area and there shout separate entrance (animal access). • Toilet and washroom easily accessible • Facilities for changing and storing clothes

  4. 2. WarehousingAreas • Storage areas should have sufficient capacity to allow orderly storage of the various categories of materials and products like. • [Raw materials, Packaging Materials.] • Storage areas should be designed to meet the required environmental conditions. • Separate sampling areas should be provided for active and raw materials. • Sampling of liquid materials, solvents, flammable materials or toxic, poisons or potent materials should be done in separate areas • All returned, rejected and recalled materials must be stored in lock and key

  5. 3. Production Areas • General category products (other than antibiotics, cytotoxic and hormones,)should be manufactured in separate manufacturing facilities. • Highly potent, sensitive or live micro-organism etc. should be produced in separate areas to avoid cross contamination. • Layout of plant is well organized and machinery and ease of cleaning, and handling. • Production areas should be regularly monitored during production and non-production periods. • The interior surfaces (walls, floors and ceilings) of the production area should be smooth and free from cracks. • Proper drainage system.

  6. 4. Quality Control Areas • Q.C. laboratories should be separate from production areas. • Areas where biological, microbiological, or radio isotope test methods are employed should be separate from each other. • A separate room or area should be provided where highly sensitive instruments area handled

  7. Plant layout • plant layout is a coordinate effort to achieve the final objective to integrate machines, materials and personnel for economic production. • It involves the location of different departments and arrangement of machinery in each department. • plant layout characteristics: • Provide space for machine/materials/storage/etc. • Flexible for future changes in capacity/ design/process etc • Deals with government rules & regulations • Safety of employees • Achieve economy

  8. Plant layouts are of four types: Process layout or functional layout. Product or straight-line layout. Fixed position or location layout Combined layout (A)Process layout or Functional layout: Definition: It is the arrangement of machines of a particular class doing a particular to of work or process as a separate department. Advantages of process layout: More effective supervision can be achieved. Reduce investment of machine High scope for expansion Breakdown of one machine does not stop the whole production

  9. (B) Product or straight-line layout: Definition: The arrangement of machines doing various operations in a line as one department. For example: In manufacture of tablet Advantages: Process of work will be quick and smooth. Cost of material handling will be reduced. Production time is reduced and manufacturing cycle can be speed up.

  10. (C)Fixed Position or Location Layout: In this layout, a complete product or a major part of it is produced at a fixed location. The facilities required are arranged around the particular work centre/location. (D)Combined Layout: This layout is a combination of product and process layouts to take the advantages of both. REFERENCE:- PHARMACEUTICAL QUALITY ASSURANCE (2ND EDITION NOV 2021) BY DR. RANDHIR SINGH DAHIYA, DR.SURESH K. BENIWAL, MS.RENU SAHARAN, PUBLISHED BY NIRALI PRAKASHAN.

  11. Thank you.

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