Construction and plant layout, maintenance, sanitation.pptx

Construction and plant layout, maintenance, sanitation Quality Assurance and Quality Control Quality Assurance Department M.pharmacy

1. Mahatma   Gandhi   Vidyamandir’s   Pharmacy college Panchavati ,Nashik Pharmaceutical Quality Assurance Department Sub : Quality Assurance and Quality Control. Prepared By Guided by Mr. Suryawanshi Kunal Anil Dr. K.V. Bhambar Sir Roll NO : 45 Presentation on Construction and plant layout, maintenance, sanitation

2. VISION- To be a Centre of professional excellence by contributing honestly to the pharmacist moulding process. MISSION- Impart high quality education to graduates Contribute to all spheres of professional activities Uphold human values and ethics Nature them into globally competent professional

3. Content Location Design and Construction Sanitation and Sanitation of sterile areas Maintenance and Maintenance of sterile areas

4. Introduction Location design, Construction and layout of premises is a vital part of GMP. Premises refers to the building and facilities where pharmaceutical processing is done. These place must comply with cGMP requirement. 4

5. Introduction There should be defined areas for the following activities. Receipt, Identification, Sampling and quarantine of incoming material. Sampling of intermediates Storage of rejected material before disposition. Storage of released materials. Production areas, Packaging and labelling, Laboratory operations. 5

6. Location 6 The following factors should be considered while selecting location. Nature of manufacturing and testing performed. Magnitude of operations. Number of products that will be processed. Storage space required for raw product, in process and finished goods. Climatic conditions and hygenic levels

7. Design and Construction The building used must be design, Constructed and maintained in the manner that permits drug production under hygienic conditions. The following factors are considered. General requirement Ancillary areas Storage areas Weighing areas 7

8. Design and Construction Production areas Quality control area’s 8

9. General requirement Lightning Electricity Sewage Toilet and washing Utilities 9

10. Ancillary areas Rest and refreshment rooms are separated from other areas. Facilities for changing cloths and washing and tiolets are easily accessible. Toilets should not be directly communicate with production areas. Animal house should be isolated from other areas. 10

11. Storage areas Storage area should be designed and adopted to ensure good storage conditions. Receiving and dispatched area should be separated and protected. In particular, they should be cleaned and dry and maintained with acceptable temperature limits. Highly active materials should be stored in safe and secure areas. 11

12. Production layout( Tablet) 12

13. Quality Control areas QC labs should be separate from production areas. Areas where biological, microbiological, test methods are employed should be separated from each other. Should avoid cross contaminations and mix-ups. Separate air supply to laboratory areas. Adequate storage space for samples, reference standards, Solvents reagents and records. 13

14. Sanitation All areas must be cleaned regularly and cleaning record must be maintained. Waste should be disposed in a safe manner. Restrooms, toilets, refreshment area must be located far from production areas. 14

15. Sanitation of sterile areas Must be cleaned and sanitized often. Regular monitoring to detect the presence of microorganisms. For spaces that are inaccessible, Fumigation should be used. Cleaning procedures should be validated. 15

16. Maintenance CFR 211 states that, “ Any building use in the manufacture, Processing, Packaging amd holding of a drug product should be in good state of repair. Facility maintenance includes a check on: Spoilage of plaster. Peeling of a paints Ceiling leakages Water, steam, gases pipeline leakage. 16

17. Maintenance Loose or broken tiles. Improper closing of doors, windows, electrical wiring or fitting. Missing tube lights. A detailed checklist maybe prepared, during routine inspection of the facilities and identified deficiencies should be rectified immediately and maintained. 17

18. Maintenance of sterile areas The sterile manufacturing areas should be maintained as per the written SOP for cleaning and disinfection. Cleanliness of air = Grade 1, Grade 2, Grade 3, Grade 4 . HVAC System. Temperature and RH. 18

19. THANK YOU 19