Pharmaceutical companies are a highly regulated industry in India, it’s not easy to start a manufacturing company like other non-regulated industries. The construction of the building requires a high level of guidance following the Schedule-M norms. The layout of the plant should be as prescribed in the Schedule-M of Drug and Cosmetic Act 1945. There are lots of questions related to the pharma plant required area according to Schedule-M of Drug & Cosmetic Act 1945.

Pharma plant required area according to Schedule-M

Location and surroundings
Buildings and premises
Water system in pharma company
Disposal of waste
Warehouse Area requirements
Area for Production
Ancillary area
Area for quality control

General requirements for pharma company as per Schedule-M?

1. Location and surroundings:- According to Schedule M the factory building(s) for the manufacture of drugs shall be so situated and shall have such measures as to avoid the risk of contamination from the external environment including open sewage, drain, public lavatory or any factory which produces disagreeable or obnoxious odor, fumes, excessive soot, dust, smoke, chemical or biological emissions.

1.2. Buildings and premises as Schedule-M:- The building(s) used for the factory shall be designed, constructed, adapted, and maintained to suit the manufacturing operations so as to permit the production of drugs under hygienic conditions. They shall conform to the conditions laid down in the Factories Act, 1948 (63 of 1948).

The premises used for manufacturing, processing, warehousing, packaging, labeling, and testing purposes shall be— (i) compatible with other drug manufacturing operations that may be carried out in the same or adjacent area/section;

(ii) adequately provided with working space to allow orderly and logical placement of equipment, materials, and movement of personnel so as to (a) avoid the risk of a mix-up between different categories of drugs or with raw materials, intermediates, and in-process material; (b) avoid the possibilities of contamination and cross-contamination by providing a suitable mechanism.

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(iii) designed/constructed/maintained to prevent the entry of insects, pests, birds, vermins, and rodents. Interior surfaces (walls, floors, and ceilings) shall be smooth and free from cracks and permit easy cleaning, painting, and disinfection.

(iv) air-conditioned, where prescribed for the operations and dosage forms under production. The production and dispensing areas shall be well-lighted, effectively ventilated, with air control facilities, and may have proper air handling units (wherever applicable) to maintain conditions including temperature and, wherever necessary, humidity, as defined for the relevant product. These conditions shall be appropriate to the category of drugs and the nature of the operation. These shall also be suitable to the comforts of the personnel working with protective clothing, products handled, and operations undertaken within them in relation to the external environment. These areas shall be regularly monitored for compliance with required specifications.

(v) provided with a drainage system, as specified for the various categories of products, which shall be of adequate size and so designed as to prevent back-flow and/or to prevent insects and rodents entering the premises. Open channels shall be avoided in manufacturing areas and, where provided, these shall be shallow to facilitate cleaning and disinfection.

(vi) the walls and floors of the areas where the manufacture of drugs is carried out shall be free from cracks and open joints to avoid the accumulation of dust. These shall be smooth, washable, coved, and shall permit easy and effective cleaning and disinfection. The interior surfaces shall not shed particles. A periodical record of cleaning and painting of the premises shall be maintained.

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3. Water system in pharma company as per Schedule-M:-

There shall be a validated system for treatment of water drawn from own or any other source to render it potable in accordance with standards specified by the Bureau of Indian Standards or Local Municipality, as the case may be, so as to produce purified water conforming to the pharmacopoeial specification. Purified water so produced shall only be used for all the operations except washing and cleaning operations where potable water may be used. Water shall be stored in tanks, which do not adversely affect the quality of water and ensure freedom from microbiological growth. The tank shall be cleaned periodically and records maintained by the licensee on this behalf.

4. Disposal of waste in pharmaceutical formulation company:-

The disposal of waste management in the pharma formulation unit should be in the following manner:-

(i) The disposal of sewage and effluents (solid, liquid, and gas) from the manufacturer (formulation) shall be in conformity with the requirements of the Environment Pollution Control Board concerning Stare.

(ii) All bio-medical waste shall be destroyed as per the provisions of the Bio-Medical Waste (Management and Handling) Rules, 1996.

(iii) Additional precautions shall be taken for the storage and disposal of rejected drugs. Records shall be maintained for all disposal of waste.

(iv) Provisions shall be made for the proper and safe storage of waste materials awaiting disposal. Hazardous, toxic substances and flammable materials shall be stored in suitably designed and segregated, enclosed areas in conformity with Central and State Legislations.

Warehouse Area requirements in the pharmaceutical company as per Schedule M?

2.1. 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.

2.2. Warehousing areas shall be designed and adapted to ensure good storage conditions. They shall be clean, dry, and maintained within acceptable temperature limits. Where special storage conditions are required (e.g. temperature, humidity), these shall be provided, monitored, and recorded. Storage areas shall have appropriate housekeeping and rodents, pests, and vermin control procedures and records maintained. Proper racks, bins, and platforms shall be provided for the storage of materials.

2.3. Receiving and dispatch bays shall protect materials and products from adverse weather conditions.

2.4. Where quarantine status is ensured by warehousing in separate earmarked areas in the same warehouse or store, these areas shall be clearly demarcated. Any system replacing the physical quarantine shall give equivalent assurance of segregation. Access to these areas shall be restricted to authorized persons.

2.5. There shall be a separate sampling area in the warehousing area for active raw materials and excipients. If sampling is performed in any other area, it shall be conducted in such a way as to prevent contamination, cross-contamination, and mix-up.

2.6. Segregation shall be provided for the storage of rejected, recalled, or returned materials or products. Such areas, materials or products shall be suitably marked and secured. Access to these areas and materials shall be restricted.

2.7. Highly hazardous, poisonous, and explosive materials such as narcotics, psychotropic drugs, and substances presenting potential risks of abuse, fire, or explosion shall be stored in safe and secure areas. Adequate fire protection measures shall be provided in conformity with the rules of the concerned civic authority.

2.8. Printed packaging materials shall be stored in safe, separate, and secure areas.

2.9. Separate dispensing areas for ß(Beta)-Lactum Lactam, sex hormones, and cytotoxic substances or any such special categories of products shall be provided with a proper supply of filtered air and suitable measures for dust control to avoid contamination. Such areas shall be under differential pressure.

2.10. Sampling and dispensing of sterile materials shall be conducted under aseptic conditions conforming to Grade A, which can also be performed in a dedicated area within the manufacturing facility.

2.11. Regular checks shall be made to ensure adequate steps are taken against spillage, breakage, and leakage of containers.

2.12. Rodent treatments (pest control) should be done regularly and at least once a year and records maintained.

Requirements of Area for Production in Schedule-M

In pharma formulation plant production area is the premises where all manufacturing-related activities take place like granulation, mixing section, compression section, coating section, blister, and packing sections. According to Schedule-M of Drug & Cosmetic Act 1945, the production area should have minimum area limitations that must be complied by every company.

3.1. The production area shall be designed to allow the production preferably in uniflow and with a logical sequence of operations.

3.2. In order to avoid the risk of cross-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.

3.3. Working and in-process space shall be adequate to permit orderly and logical positioning of equipment and materials and movement of personnel to avoid cross-contamination and to minimize the risk of omission or wrong application of any manufacturing and control measures.

3.4. Pipe work, electrical fittings, ventilation openings, and similar service lines shall be designed, fixed, and constructed to avoid the creation of recesses. Service lines shall preferably be identified by colors and the nature of the supply and direction of the flow shall be marked/indicated.

Ancillary area for pharma formulation company:-

The ancillary area is the space provided for personnel where no production or storage of any material is carried out. These places are dedicated to using by staff and labor like toilets, change room, etc, the ancillary area should comply as below:

4.1. Rest and refreshment rooms shall be separate from other areas. These areas shall not lead directly to the manufacturing and storage areas.

4.2. Facilities for changing, storing clothes and for washing and toilet purposes shall be easily accessible and adequate for the number of users. Toilets, separate for males and females, shall not be directly connected with production or storage areas. There shall be written instructions for cleaning and disinfection for such areas.

4.3. Maintenance workshops shall be separate and away from production areas. Whenever spares, changed parts, and tools are stored in the production area, these shall be kept in dedicated rooms or lockers. Tools and spare parts for use in sterile areas shall be disinfected before these are carried inside the production areas.

4.4. Areas housing animals shall be isolated from other areas. The other requirements regarding animal houses shall be those as prescribed in Rule 150-C(3) of the Drugs and Cosmetics Rules, 1945 which shall be adopted for production purposes.

Required area for quality control section in pharma company according to GMP?

The quality control section is an important area in every pharmaceutical manufacturing company. There are some limitations for areas required for laboratory or quality control sections. The area should be separated from production activities. According to Schedule-M, some important instructions are below:

5.1. Quality Control Laboratories shall be independent of the production areas Separate areas shall be provided each for physicochemical, biological, microbiological, or radioisotope analysis. A separate instrument room with an adequate area shall be provided for sensitive and sophisticated instruments employed for analysis.

5.2. 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.

5.3. The design of the laboratory shall take into account the suitability o| construction materials and ventilation. Separate air handling units and other requirements shall be provided for biological, microbiological, and radioisotopes testing, areas. The laboratory shall be provided with a regular supply of water of appropriate quality for cleaning and testing purposes.

5.4. Quality Control Laboratory shall be divided into separate sections i.e. for chemical, microbiological, and wherever required, biological testing. These shall have adequate area for basic installation and for ancillary purposes. The microbiology. section shall have arrangements such as airlocks and laminar airflow work station, wherever considered necessary.

Conclusion:

Area eligibility for a pharma plant is a very important factor for obtaining the GMP certification. In Schedule-M of Drugs & Cosmetics Act, the requirements for area limits for various sections of pharma companies are given in detail. If you are planning to set up a pharma company in near future then you must follow the guidelines given in Schedule-M, it will help you at the time of obtaining a drug license and other audits. The layout of the plant must be following the norms of Schedule-M. If you are looking for a good running plant in north India or a new plant you can contact us for better consultancy services.

References:-

Schedule-M>Drug & Cosmetic Act-Page-442> Vijay Malik-Handbook-21st edition.
Drug & Cosmetic Act-CDSCO official website.
REGULATORY REQUIREMENTS FOR PHARMACEUTICAL PLANTS-bspublications.net