cGMP Guidelines According to Schedule M

cGMP GUIDELINES ACCORDING TO SCHEDULE M

1. c GMP GUIDELINES ACCORDING TO SCHEDULE-M PRESENTED BY: Mr. Ankush P. Jadhav & Miss. Tejashree R. Kedar M. Pharm (PQA) Email id: [email protected], ……….. [email protected] 1

2. c GMP GUIDELINES ACCORDING TO SCHEDULE M 2

3. DEFINITION ● WHO defines Good Manufacturing Practices (GMP) as “that part of quality assurance which ensures that quality products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization”. 3

4. ● The guiding principle of GMP is that quality is built into a product, and not just tested into a finished product. Therefore, the assurance is that the product not only meets the final specifications, but that it has been made by the same procedures under the same conditions each and every time it is made. ● All of the controls must follow prescribed, formal, approved procedures, written as protocols, SOPs, or Master Formulae, describing all the tasks carried out in an entire manufacturing and control process. 4

5. AREAS TO BE COVERED ● Personnel ● Premises ● Equipment ● SOP’s ● Raw Materials ● Self Inspection And Audit ● Master Formula Records ● Batch Manufacturing Records ● Warehousing Area ● Reference Samples ● Validation 5

6. Good Manufacturing Practices (GMP) ● Production ● Utilities ● Equipment ● Dosage form and data verification (development, validation and specification) 6

7. PERSONNEL 7

8. It include… ● Qualified Personnel a) Experienced b) Sufficient Number ● Written job description ● Trained ● Health ● Diseases 8

9. PRODUCTION ● Product focus ● Equipment ● Dosage form ● Documentation 9

10. RAW MATERIALS ● An Inventory should be maintained for Raw materials to be used at any stage of manufacture ● Records should be maintain as per Schedule U ● Should be purchased from approved sources ● Must be checked by QC department on receipt ● Should be labeled. 10

11. STANDARD OPERATING PROCEDURE ● SOPs are the detailed written instructions that specify how a test or administrative procedure is to be performed, or how a piece of equipment is operated, maintained and calibrated. SOPs describe the "standard" approved procedures that are routinely carried out in a GMP facility. They indicate exactly how things are done, and are kept current by review and approved revision on a predetermined schedule (usually annual), or when planned changes are made to the procedure or equipment and reagents used in the procedure. 11

12. It include… ● For Equipment ● For sampling ● For Testing ● For Process ● For Packaging 12

13. MASTER FORMULA RECORDS ● There shall be MFR relating to all manufacturing procedures for each product and batch size to be manufacture ● It should include- a) The name of the product b) Quantity of all starting materials to be used c) A statement of the expected final yield with acceptable limits d) Principal equipment to be used e) Detailed stepwise processing instructions and the time taken for each step f) Any special precautions g) Packing details and Specimen labels 13

14. BATCH MANUFACTURING RECORDS ● There shall be Batch processing record for each product. ● During Manufacturing or Processing the following information shall be recorded It include… ● The name of the product ● The number of Batch being manufactured ● Dates and time of commencement of batch and completion ● Amount of Product obtained 14

15. PREMISES 15

16. LOCATION ● Geographical, climate and economic factors ● Premises must be located to minimize risks of cross-contamination e.g. not located next to a malting factory with high airborne levels of yeast ● Pollution control 16

17. DESIGN ● Minimize risks of errors ● Permit effective cleaning ● Permit effective maintenance ● Avoid cross-contamination, build-up of dirt and dust ● Maximum protection against entry of insects, birds and animals ● Separate facilities for other products such as some antibiotics, hormones, cytotoxic substances ● Hygiene ● Eating, Drinking, Smoking Should not be allowed in the Production area 17

18. CONSTRUCTION ● Measures should be taken to prevent cross-contamination ● Dust control measures (including extraction of dust and air) ● No areas for dust accumulation ● Easily cleanable surfaces ● Proper air supply ● Use of HEPA filter’s 18

19. FACILITY LAYOUT 19

20. 20

21. ACTIVITIES • Sampling (starting materials and packaging materials) • Weighing • Mixing • Milling • Sieving/sifting/screening • Granulation • Drying • Sieving • Blending • Compression • In process bulk stores • Packaging areas (primary and secondary packaging) • Finished product 21

22. EQUIPMENTS 22

23. ● Equipment shall be Located, Designed, Constructed, Adapted and maintained to suit the operation to be carried out. ● Should be made of non reactive material such as High grade of steel ● Equipment should be- a) Calibrated b) Checked c) labelled d) Sterilized 23

24. ● Sieving/sifting – sifter (e.g. vibrosifter) ● Mixing – mixer ● Granulation - granulator ● Drying – fluid bed drier ● Blending – octagonal blender ● Compression – compression machine ● Packaging - blister machine ● Others include Metal detector, sieves, punches and dies ● In process quality control instruments and equipment may include hardness tester, disintegration tester, balance, Vernier caliper • Compressed air – machine operation, drying of equipment and parts • Water – washing, rinsing, manufacture • Steam – cleaning 24

25. UTILITIES ● DRAINAGE SYSTEM ● VENTILATION AND AIR CONDITIONING ● GAS SYSTEMS ● SANITATION ● WATER 25

26. DOCUMENTATION REVIEW Equipment and utilities… ● SOPs (operation, cleaning, calibration) ● Records and use logs ● Calibration records/certificates ● Preventative maintenance ● Qualification 26

27. DOCUMENTATION REVIEW Product related… ● Batch Manufacturing document as per product dossier ● Process Validation protocol and report ● Stability batches ● Batch records 27

28. VALIDATION ● Essential part of GMP ● Necessary to achieve the intended results ● A written record is prepared summarizing recorded result and conclusions shall be prepared , documented and maintained ● Should be necessary when… a) Any new master formula or method of preparation is adopted b) For critical process c) Any changes in the equipment or when using a new equipment, it is first validated to demonstrate its consistency of required quality 28

29. VALIDATION STATUS ● Validation Master Plan ● Manufacturing areas ● Utilities ● Equipment ● Manufacturing process ● Cleaning validation ● Computer systems 29

30. WAREHOUSING AREA ● Warehousing area should be designed and adapted to ensure good storage conditions. ● Should be Clean, dry and maintained with acceptable temperature limits. ● Should have appropriate house-keeping, pests control. ● Separate sampling area for active raw material and excipients. ● Every Material stored should be labeled properly. ● Fire Prevention 30

31. REFERENCES:   "Good Manufacturing Practices" . Health Canada. Government of Canada. 27 February 2015. Retrieved 2 February 2018. Jump up^   Medicines and Healthcare Products Regulatory Agency (20 October 2017).  "Good manufacturing practice and good distribution practice" . Gov.uk. Retrieved 2 February2018.   "Current Good Manufacturing Practices (CGMPs)" . U.S. Food and Drug Administration. 27 December 2017. Retrieved 2 February 2018.   “GMP Guidelines" . National Agency for Food and Drug Administration and Control. Retrieved 2 February 2018 . 31

32. THANK YOU