Gmp premicses
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The document discusses recommendations for the design, construction, and maintenance of facilities for pharmaceutical manufacturing. It covers key areas like location, plant layout, storage, production, and quality control. Specific recommendations are provided for maintaining clean and controlled environments in different areas to minimize risks of contamination and ensure product quality. Personnel hygiene, health monitoring, and environmental monitoring are also important aspects discussed.
Gmp premicses
- 1. Presented By Mr. Jagadeesh Tekkali M.Pharmacy 1st year 15AC1S0414 VIGNAN INSTITUTE OF PHARMACEUTICAL TECHNOLOGY An ISO 9001:2008, 14001:2004, OHSAS 18001:2007 Certified Institution Beside VSEZ, kapujaggarajupeta, Duvvada,VISAKHAPATNAM-530046 (Approved by A.I.C.T.E & PCI and affliated to JNTUK)
- 2. Location Design Construction Maintenance Plant layout Sanitations Environmental control Sterile areas Contamination control
- 3. Principle Important aspects to be kept in mind to ensure the Quality product several operations to be carried out for different dosage forms and product range: Location Design Construction Adaptation Maintenance
- 4. Location Geography, climate, noise and economic factors Neighbours What do they do? What impact can they have on the business? Pollution/effluent control Minimum risk for contamination of products and materials
- 5. Principle 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
- 6. Plant layout The plant layout and design should aim to: Minimize risks of errors Permit effective cleaning Permit effective maintenance Avoid cross-contamination, build-up of dirt and dust Avoid any adverse effect on the quality of products
- 7. Design Principles Keep in mind: Material flow People flow Process flow Ensure logical flow
- 8. Design Suitable design and construction to facilitate good sanitation Cleaning and disinfecting according to detailed written procedures – records maintained Maximum protection against entry of insects, birds and animals Procedure for rodent and pest control
- 9. Construction Suitable materials Electrical supply Suitable lighting (especially for visual on-line checks) Temperature and relative humidity control Appropriate and effective ventilation These may affect products during manufacture or storage as well as functioning of equipment
- 10. The temperature and relative humidity should be controlled, monitored in accordance with an SOP, and the results recorded. The limits should be appropriate according to the materials stored and product processed
- 11. Construction Dust generating operations e.g. during sampling, weighing, mixing, packing of powders, etc.) Measures should be taken to prevent cross- contamination Measures to facilitate cleaning
- 12. Maintenance Careful maintenance done Repairs and maintenance should not present any hazard to the quality of the products
- 14. some recommendations for specific areas Ancillary areas Storage areas Weighing areas Production areas Quality control areas Control of contamination maintain few specific areas such as
- 15. Ancillary Areas Rest and refreshment rooms separate from manufacturing and quality control areas Changing, washing and toilet areas accessible and appropriate numbers Maintenance workshops separated from production - if not possible – tools in reserved areas Animal houses well isolated – separate air handling and entrance
- 17. Cleaning of incoming containers Cleaning with a cloth, or duster Cleaning by using a vacuum cleaner Use of air curtains and air tunnels
- 18. Storage areas Storage areas of sufficient capacity Orderly storage of categories of materials and products Separate and segregated areas: starting materials, packaging materials, intermediates, bulk, finished products, quarantined, released, rejected, returned and recalled products and materials
- 20. Storage areas Appropriate temperature and relative humidity conditions within defined limits Provided, controlled, monitored and recorded Good storage conditions: clean, dry and appropriate lights
- 21. Storage areas Quarantine area: clearly marked and access restricted A separate sampling area is the norm: no risk for contamination or cross-contamination Segregated areas for rejected, recalled and returned materials and products Safe and secure areas for highly active, radioactive materials, narcotics and other materials (risk of abuse, fire, explosion)
- 23. QC laboratories should be separate from production areas Separate areas for biological, microbiological and radioisotope methods Suitable design with sufficient space to avoid mix-ups and cross-contamination Suitable space for storage samples, reference standards, solvents, reagents and records Quality Control areas
- 24. Quality Control areas Suitable construction materials Prevention of fumes Ventilation Separate air supply (production and QC) Separate rooms for some instruments to protect them from interference (e.g. electrical, vibration, moisture, etc.) See supplementary training on QC laboratories
- 25. Health, clothing ,sanitation of workers – The personnel handling Beta-lactum antibiotics shall be tested for Penicillin sensitivity before employment and those handling sex hormones, cytotoxic substances and other potent drugs shall be periodically examined for adverse effects. These personnel should be moved out of these sections (except in dedicated facilities), by rotation, as a health safeguard. Prior to employment, all personnel, shall undergo medical examination including eye examination, and shall be free from Tuberculosis, skin and other communicable or contagious diseases. Thereafter, they should be medically examined periodically, at least once a year. Records shall be maintained thereof. The licensee shall provide the services of a qualified physician for assessing the health status of personnel involved in different activities. All persons, prior to and during employment, shall be trained in practices which ensure personnel hygiene. A high level of personal hygiene shall be observed by all those engaged in the manufacturing processes. Instructions to this effect shall be displayed in change-rooms and other strategic locations.
- 27. No person showing, at any time, apparent illness or open lesions which may adversely affect the quality of products, shall be allowed to handle starting materials, packaging materials, in-process materials, and drug products until his condition is no longer judged to be a risk. All employees shall be instructed to report about their illness or abnormal health condition to their immediate supervisor so that appropriate action can be taken. Direct contact shall be avoided between the unprotected hands of personnel and raw materials, intermediate or finished, unpacked products
- 28. Environmental Monitoring – All environmental parameters shall be verified and established at the time of installation and thereafter monitored at periodic intervals. The recommended frequencies of periodic monitoring shall be as follows: ( a ) Particulate monitoring in air – 6 Monthly (b) HEPA filter integrity testing (smoke testing) – Yearly (c) Air change rates – 6 monthly (d) Air pressure differentials – Daily (e) Temperature and humidity – Daily (f) Microbiological monitoring by settle plates and/or swabs in aseptic
- 29. Class 100 Area - parentrals Class 1000 Area- manufactring,production Class 10000 Area-filling,sealing. Class 100000 Area-packaging,labeling.
- 30. Terminally Sterilized Products – Preparation of primary packaging material such as glass bottles, ampoules and rubber stoppers shall be done in at least Grade D environment. Where there is unusual risk to the product from microbial contamination, the above operation shall be done in Grade C environment. All the processes used for component preparation shall be validated. Filling of products requiring terminal sterilization shall be done under Grade A environment with a Grade C background. Preparation of solutions, which are to be sterilized by filtration, shall be done in Grade C environment, and if not to be filtered, the preparation of materials and products shall be in a Grade A environment with Grade B in background. Filtration ( Membrane )— ( i ) Solutions for Large Volume Parenterals shall be filtered through a nonfiber releasing, sterilizing grade cartridge/membrane filter of nominal pore size of 0.22 μ for aseptic filling whereas 0.45 μ porosity shall be used for terminally sterilized products
- 31. ii ) A second filtration using another 0.22 μ sterilizing grade cartridge/membrane filter shall be performed immediately prior to filling. Process specifications shall indicate the maximum time during which a filtration system may be used with a view to precluding microbial build-up to levels that may affect the microbiological quality of the Large Volume Parenterals. ( iii ) The integrity of the sterilized filter shall be verified and confirmed immediately after use by an appropriate method such as Bubble Point, Diffusive Flow or Pressure Hold Test.