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1 PREMISES Presented by, Darshna K P atel ( M.Pharm,Q.A ) Guided by, Mrs.Riddhi Madhu M.V.B.M College of pharmacy,Dumiyani


PRINCIPLE Important aspects to be kept in mind to ensure the suitability of the operations to be carried out for different dosage forms and product range. Location Design Construction Adaptation Maintenance 2


PREMISES Principle. Premises must be located, designed, constructed, adapted, and maintained to suit the operations to be carried out . General 1) The layout and design of premises must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross contamination,build -up of dust or dirt, and, in general, any adverse effect on the quality of products . 2) Where dust is generated (e.g. during sampling, weighing, mixing and processing operations , packaging of powder), measures should be taken to avoid cross-contamination and facilitate cleaning . 3

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3) Premises should be situated in an environment that, when considered together with measures to protect the manufacturing process, presents minimum risk of causing any contamination of materials or products . 4) Premises used for the manufacture of finished products should be suitably designed and constructed to facilitate good sanitation . 5) Premises should be carefully maintained, and it should be ensured that repair and maintenance operations do not present any hazard to the quality of products. 6) Premises should be cleaned and, where applicable, disinfected according to detailed written procedures. Records should be maintained. 4

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7) Electrical supply, lighting, temperature, humidity and ventilation should be appropriate and such that they do not adversely affect, directly or indirectly, either the pharmaceutical products during their manufacture and storage, or the accurate functioning of equipment . 8) Premises should be designed and equipped so as to afford maximum protection against the entry of insects, birds or other animals. There should be a procedure for rodent and pest control . 9) Premises should be designed to ensure the logical flow of materials and personnel . 5

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10) Premises , including areas containing open tanks, should be of suitable construction.They should provide a suitable environment for manufacturing operations and should be adequately adapted to and of a sufficient size for their intended use. The premises should not contribute to actual or potential mixups or contamination of the active pharmaceutical ingredients. The arrangement should provide for a logical work flow . 11) For special purposes, such as the production of sterile products and of certain antibiotics, hormones, and cytostatic substances, separate specifically designed enclosed areas with completely separate air-handling systems should be provided. 6

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12) To maintain hygienic working conditions, the premises should include facilities for changing clothes, washing, and toilet purposes as well as for eating, drinking , and smoking . 13) All premises should, as far as possible, be designed to avoid the unnecessary entry of supervisory or control personnel. Grade B areas should be designed so that all operations can be observed from outside . 14) In clean areas, all exposed surfaces should be smooth, impervious and unbroken in order to minimize the shedding or accumulation of particles or microorganisms and to permit the repeated application of cleaning agents and disinfectants, where used. 7

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16) Pipes and ducts and other utilities should be installed so that they do not create recesses, unsealed openings and surfaces that are difficult to clean . 17) Changing rooms should be designed as airlocks and used to separate the different stages of changing, thus minimizing particulate and microbiological contamination of protective clothing . 18) Sinks and drains should be avoided wherever possible and should be excluded from grade A/B areas where aseptic operations are carried out. Where installed , they should be designed, located and maintained so as to minimize the risks of microbiological contamination; they should be fitted with effective, easily cleanable traps and with air breaks to prevent back-flow. 8


Location 1. Geography, climate, noise and economic factors 2.Neighbours a) What do they do? b) What impact can they have on the business? 3.Pollution/effluent control 4.Minimum risk for contamination of products & materials 9


PREMISES 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 10

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- The factory building(s) for manufacture of drugs shall be so situated and shall have such measures as to avoid risk of contamination from external environmental including open sewage, drain, public lavatory or any factory which product disagreeable or obnoxious odour, fumes, excessive soot, dust, smoke,chemical or biological emissions. 11


PLANT LAYOUT 12 The 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


BUILDING & FACILITY 13 (a) Any building or buildings used in the manufacture, processing, packing or holding of drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance, and proper operations.Regarding buildings and facilities, there are two major areas of concern: the external environment and the internal environment . The external environment must be amenable to the location of well-designed and constructed buildings. It is insufficient that the buildings in which the production operations are to occur are clean and orderly and of suitable size and construction.


CONSTRUCTION 1. Adequate space for future expansion. 2. Zoning laws to allow anticipated development while restricting undesirable developments in the vicinity. 3. Availability of water (quality and quantity), power, fuel, sewage and waste-stream removal. 4. Accessibility for employees (availability of public transportation ), materials , and visitors (customers, suppliers). 5. Environmental issues such as site history; soil, water, and air quality; and geological and topological issues (potential for flooding, earthquakes, foundation instability). 6. Proximity of undesirable activities likely to pollute or act as a source of vermin, insects, odor , or microorganisms—such as other industries, disposal sites, or open mining. 14


EQUIPMENT Manufacturing equipment should be designed, constructed, located, and maintained in such a way as to: (a) be suitable for its intended use; (b) facilitate thorough cleaning; (c) minimize the risk of contamination of products and containers during production ; and (d) facilitate efficient and, if applicable, validated and reliable operation. 15

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Equipment shall be located, designed, constructed, adapted and maintained to suit the operations to be carried out. The layout and design of the equipment shall aim to minimise the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt and, in general any adverse effect on the quality of products. Each equipment shall be provided with a logbook, wherever necessary . Balances and other measuring equipment of an appropriate range, accuracy and precision shall be available in the raw material stores, production and in process control operations and these shall be calibrated and checked on a scheduled basis in accordance with Standard Operating Procedures and records maintained. 16


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 17


SANITATION 1. The manufacturing premises shall be cleaned and maintained in an orderly manner, so that it is free from accumulated waste, dust, debris and other similar material . 2. A validated cleaning procedure shall be maintained . 3. The manufacturing areas shall not be used for storage of materials, except for the material being processed. 4. A routine sanitation program shall be drawn up and observed, which shall be properly recorded and which shall indicate— (a) specific areas to be cleaned and cleaning intervals; (b) cleaning procedure to be followed, including equipment and materials to be used for cleaning; and (c) personnel assigned to and responsible for the cleaning operation. 18

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5 . Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a clean and sanitary condition.Any such building shall be free of infestation by rodents, birds, insects and other vermin (other than laboratory animals). Trash and organic waste matter shall be held and disposed of in a timely and sanitary manner . 6 . There shall be written procedures assigning responsibility for sanitation and describing in sufficient detail the cleaning schedules, methods, equipment, and materials to be used in cleaning the buildings and facilities; such written procedures shall be followed . 7 . There shall be written procedures for use of suitable rodenticides , insecticides, fungicides , fumigating agents and cleaning and sanitizing agents. 8 . Sanitation procedures shall apply to work performed by contractors or temporary employees as well as work performed by full-time employees during the ordinary course of operations. 19


MAINTANANCE Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a good state of repair. Deterioration of buildings not only presents a poor image of the facility, it can also impact on product quality. Cracks and holes in walls, floors, or ceilings can provide access for insects, rodents, birds, dirt, or microorganisms. They can also hinder cleaning and sanitation, thereby increasing the potential for cross contamination or microbial multiplication. 20

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Floor cracks can also become a safety hazard for people or even dislodge materials from trucks. The ingress of water from roof leaks can cause significant damage to materials and equipment, give rise to electrical failures and fires and result in damage to the basic structure of the building. Additionally , holes in the roof or near the tops of buildings provide ready access to birds, which may then be encouraged to nest within the building. 21


SPECIFIC AREAS Review some recommendations for specific areas in the following slides: Warehousing areas Ancillary areas Storage areas Weighing areas Production areas Quality control areas 22

Warehousing area:

Warehousing area Adequate areas shall be designed to allow sufficient and orderly warehousing of various categories of materials and products like starting and packaging materials , intermediates, bulk and finished products, products in quarantine, released, rejected , returned or recalled, machine and equipment spare parts and change items . Warehousing areas shall be designed and adapted to ensure good storage conditions . They shall be clean, dry and maintained with acceptable temperature limits,where special storage conditions are required (e.g. temperature, humidity), these shall be provided , monitored and recorded . 23

Ancillary Area:

Ancillary Area 24 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

Ancillary area :

Ancillary area 25

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Storage areas 1. Storage areas of sufficient capacity. 2. Orderly storage of categories of materials and products. 3. Separate and segregated areas: starting materials, packaging materials, intermediates, bulk, finished products, quarantined, released, rejected, returned and recalled products and materials 26

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Weighing areas Weighing operations – in separated areas Provision for dust control Smooth, impervious, durable, easy-to-clean finishes Cleaning procedures and records Documentation, e.g. SOPs, logs and records 28

Weighing area :

Weighing area 29


PRODUCTION AREA The production area shall be designed to allow the production preferably in uni -flow and with logical sequence of operations. In order to avoid the risk of corss -contamination, separate dedicated and self-contained facilities shall be made available for the production of sensitive pharmaceutical products like penicillin or biological preparations with live microorganisms . Separate dedicated facilities shall be provided for the manufacture of contamination causing and potent products such as Beta- Lactum , sex hormones and cytotoxic substances. 30


QUALITY CONTROL AREA Quality Control Laboratories shall be independent of the production areas. Separate areas shall be provided each for physico -chemical, biological, microbiological or radio-isotope analysis. Separate instrument room with adequate area shall be provided for sensitive and sophisticated instruments employed for analysis. Quality Control Laboratories shall be designed appropriately for the operations to be carried out in them. Adequate space shall be provided to avoid mix-ups and cross-contamination. Sufficient and suitable storage space shall be provided for test samples , retained samples, reference standards , reagents and records. 31


REFERENCES Sidney H. Willig , "Good Manufacturing Practices for Pharmaceuticals", Drugs and Pharm. Sci. Series, Vol. 109,5 th edition Marcel Dekker Inc. 2. Good Manufacturing Practices for Pharmaceuticals, Sixth Edition edited by Joseph D. Nally , Nallianco LLC New Vernon, New Jersey, U.S.A. New York. 3. WHO Guidelines. 4. Schedule M 32

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