GMP premises & equipment

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Presented by: Ms . Ashritha narikimalli, I M.Pharm., Pharmaceutical Analysis & quality assurance Guided by: Mrs . S. namratha, M.Pharm ., Asst . Professor , Aditya institute of pharmaceutical sciences & research. GMP PREMISES & EQUIPMENT


G ood M anufacturing P ractice is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP


Premises must be located, designed, constructed, adopted and maintained to suit the operations to be carried out . PREMISES


Objectives The objectives to be achieved according to Schedule M: Suitability of premises to carry out intended operation. Minimizing risk of errors. Permitting effective cleaning and maintenance. Minimizing contamination.

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To achieve these objectives, consideration has to be given to Location Layout, design construction Maintenance


LOCATION Selection of site, an important decision, should be taken after careful consideration of various aspects Location of factory site should be hygienic. Surrounding should have minimum source of pollution. Should be away from open sewage, drain, public lavatory. Should be away from any factory which produces disagreeable or obnoxious odour or fumes or large quantity of soot, smoke , dust, chemical or biological emissions.

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Other factors should be considered while selecting the site for pharmaceutical factory include: Transportation facility for transportation of men equipment and materials. Availability of suitable water. Availability of electricity power. Availability of maintenance facility for repair and maintenance of plant. Availability of communication facilities. Proximity of civic facilities like education, housing, recreation, local transport, shopping etc. for factory personnel. Local statutory restrictions. Government incentives like cash subsidies, tax exemptions etc. It is very difficult to find a site which will have all the requisite plus points. Therefore a balance has to be struck between plus and minus points.


LAYOUT, DESIGN AND CONSTRUCTION First step in construction of building is to make layout. There are many points we should be kept in mind while designing a layout for factory premises. Salient features include Total area of land available percentage of area that can be covered under local laws. Dosage form to be manufactured (ex: tablets, capsules, ointments, injections etc.) Scale of operation i.e., small scale, medium scale, large scale. Type of equipment, plant and machinery to be used i.e., manual semi automatic, automatic.

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Different area that are required to be provided in a pharmaceutical factory (i.e., storage area, weighing area, production area, quality control area , ancillary area). Requirements of separate buildings for hazardous materials/process or complete isolation of some buildings. Specific requirement of a dosage form (ex: segregated area for granulation , compression and coating processes in manufacture of tablets) Specific requirements of utilities (ex: boiler for generation of steam, gases, water). Logical flow of materials i.e., goods in store-production-quarantine and assembly-ware house-goods out. Provision of national / local factory laws (in India the factory buildings should comply with the provisions of the factories act and the rules made there under). Future projects.

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Some guidelines in preparing layout, designing & construction of buildings Rest and refreshment rooms should be separate from manufacturing and control areas. Facilities for changing and storing clothes should be easily accessible and appropriate for the number of users. Toilets should not communicate directly with production or storage area.

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Maintenance workshops if possible be separate from production area. Animal houses should be well isolated from other areas, with separate entrance and air-handling facilities. Floors should be smooth & impervious. Internal walls, ceiling should be plastered with cement to smooth finish. Pipe work, light fittings, ventilation and other services should be designed to avoid the difficulty to clean. Drains should be of adequate size and designed to prevent back-flow. Open channels should be avoided. Production area should be effectively ventilated, with air-control facilities.

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Area with inflammable materials should be constructed with flame proof materials. QC laboratories should be separated from production areas. Areas where biological, microbiological or radioisotope test methods are employed should be separated from each other. Premises for packing should be specifically designed to avoid mix-ups or cross-contamination.


LIGHTING Adequate lighting in pharmaceutical unit is necessary. Without adequate light workers can not carryout their work satisfactorily. If work area has too little light, it will cause eye strain and fatigue, particularly when detailed work is to be performed. Too much light is also not desirable as it can cause glare and dazzle. For adequate lighting , care should be taken for Position of source of light Selection of tubes or bulbs Intensity of light.


HEATING , VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM Revised schedule M recommend separate air handling units (AHU) for several facilities Ambient air may have different contaminants, mostly dust. Normally bacteria settle themselves on dust particles. Pharmacopoeias lay down total microbial count per 1gm or/ml of material in monograph of several raw materials and finished products. For proper working , a comfortable temperature is required. For this reason , air may either be heated or cooled. Therefore air handling systems are often called HVAC systems.


MAINTENANCE Maintenance literally means “the process or practice of keeping something in good condition.” Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in good state of repair. The building used in manufacture process, packing and holding of products shall be in a good condition.


DEFICIENCIES IN MAINTENANCE The deficiencies that should be avoided in industries: Building under deterioration state Cracks and holes on the walls, floors and ceilings Deep floor cracks Leakage of water from roofs Holes in roofs or top of buildings Damage to insulation or pipes Light fittings Improper building maintenance and inspection programs.


IMPORTANCE OF PROPER MAINTENANCE Avoidance of contamination. Good product quality can be obtained. Accidents can be avoided. Systematic and smooth functioning of the industry. Safety can be enhanced.


Equipment is defined as any piece of plant, machinery, instrument etc., which is used to carry out specific activity or operation. E.g.: mixer, granulator, dryer, UV, HPLC etc. Equipment is important because all pharmaceutical manufacturing depend upon good performance of equipment. Equipment can effect the quality of drug to a great extent. EQUIPMENT


GENERAL SPECIFICATIONS What operations you want to perform in this equipment? What capacity we should have? What materials we are going to use in this equipment? They should cause any interaction with materials. How this equipment will be cleaned? Avoid the problem of cleaning validation. Do we have trained operators to operate this equipment? How many people are required to operate this equipment? What is the starting & stopping time of equipment?


SELECTION Equipment used in manufacturing process, handing or storage should be of suitable design and of adequate capacity to facilitate the operation for which it is intended. Design should be such that it can be cleaned & maintained easily. Design should be such that it should not allow substances like lubricants, coolants to come in contact with any in-process materials. Valves, lubricants, drips etc., should be so located that these do not effect the product adversely in case of leakage. Equipment processing inflammable materials should be equipped with explosion proof electrical parts.

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Parts of equipment which come into contact with the raw material, intermediate, bulk or finished product should be made of material, which would not be reactive, additive or absorptive. Equipment used for critical steps should have, as far as possible, recording devices. If not, other measuring devices like pressure gauge, temperature gauge etc., should be fixed. It would be better if the manufacturing of equipment would be indicated by alarm or other suitable indicating system To conform whether the equipment design has GMP principles, design qualification (DQ) should be carried out when the equipment is purchased.




INSTALLATION & LOCATION Equipment should be located such that contamination of substances by other materials used in same area is minimized either by dust carried in air or by spillage of liquid. Equipment should be located at sufficient distance from the other to avoid congestion & also to ensure that products being processed do not get admixed or confused with each other. All open mechanical belts & pulleys should be covered with safety guards. Water and other utility service lines should be so installed as to be easily accessible during all phases of operation. These should have color scheme & should be markedly shown that they are recognized easily. Pipes, tanks, jackets which handle steam or coolant should be properly insulated so that risk of injury to workers & energy loss are minimized. IQ, OQ, PQ should be performed for newly purchased equipment


MAINTENANCE The purpose of cleaning is to remove product residues of previous product or batch & to clear & sanitize the equipment for the next batch. Equipment should be cleaned regardless of their size. Large equipment which are fixed are too heavy to move should be cleaned on location. Detachable parts & small equipments should be taken to cleaning area assigned for purpose. Written cleaning procedures or SOP should be prepared for all the equipments. These should be in the language that is understood by the workers and be available in section.


E.g.: DRY PRODUCTS Remove labels with the help of brush, remove product residues form previous batch. Disassemble & clean disassembled parts further with the help of brush. Wash parts with soap & jet of water using a scrubber, then wash with sufficient clean water. Drain out water & dry in clean area. Where necessary, sterilize with 70% isopropyl alcohol or other suitable disinfectant. After drying the parts, assemble the equipment.

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Whenever there product change over, final rinse water should be tested for active ingredients of the last product. The tests for active ingredients could be limit tests and could be performed by color development or by UV spectrophotometer. Before use, equipment should be inspected for cleanliness and should be cleaned by person responsible for job. Tags with words like “Equipment cleaned” “cleaned” “Ready for use” can be used for clean equipment. Cleaned equipment should be covered to protect from extraneous contamination. Recording equipment should be calibrated at scheduled intervals and records should be maintained. Cleaning & sanitization procedures employed for cleaning of equipment should be validated.

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SOP should be prepared for cleaning & sanitization of major equipments in production area. Some important points in preparing SOP are: Selection of cleaning agent depends on previous product processed Concentration of cleaning agent. Where equipment is to be washed with running water, time period should be specified in SOP. Selection of sanitizing agent. Conc. of sanitizing agent. Cleaning implements like brushes, scrubber etc., The SOP for major production equipment can be given numbers. These numbers can be indicated in the log-book for cleaning & sanitization of equipment.

Format which is used as a guide for log-book:

Format which is used as a guide for log-book M/s _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Log-book for cleaning & sanitization of _ _ _ _ _ _ _ _ DATE TIME SOP NO. CLEANED BY CHECKED BY Equipment which go out of order & can be removed from the section should be removed. If the defective equipment cannot be removed out the section, it should be clearly labeled as “defective”.


REFENRENCE WHO, Quality assurance of pharmaceuticals, Good manufacturing practices and inspection, Pharma book syndicate. P. P. Sharma, How to practice GMPs, 6 th edition, Vandana publications Pvt. Ltd., Delhi. Y. Anjaneyulu, R. Marayya, Quality assurance and quality management in pharmaceutical industry, Pharma book syndicate. S. Iyer, Guidelines on cGMP and quality of pharmaceutical products, D. K. Publications.

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