Objectives and policies of c gmp, layout of building and services

Pharmaceutical Quality affects every individual. Therefore GMP is required to ensure the quality of the particular drug or dosage form. In this presentation you will go through some basic information about cGMP and layout of buildings.

1. Objectives And P olicies O f cGMP, L ayout O f B uildings A nd S ervices PRESENTED BY- SHARWARI A SAPATE M. PHARMACY F Y DEPARTMENT OF PHARMACEUTICS AISSMS COLLEGE OF PHARMACY

2. Contents. GMP cGMP Importance of cGMP Objectives of cGMP Policy of cGMP Layout of buildings, services and equipment

3. GMP Good Manufacturing Practice is that part of quality assurance which ensures that the products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by marketing authorisation.

4. Current good manufacturing practices (cGMP) cGMP stands for current good manufacturing practices. Here current stands for updating technology in GMP. Food and drug administration regulates the quality of pharmaceuticals products very carefully. The main regulatory standard for ensuring pharmaceuticals quality is cGMP. Consumer expect that each batch of medicines they take will meet quality standards so that will be safe and effective. cGMP provides for system that assure proper design, monitoring and control of manufacturing process, packing, holding of drug and facilities.

5. Why are cGMP so important? A consumer usually cannot detect that the product is safe or efficacious. Poor quality medicines are not only a health hazard, but a waste of money. Therefore, it is important that a drugs are manufactured under conditions and practices required by the cGMP regulations to assure that the quality is built into the design and manufacturing process at every step. Facilities that are in good conditions, equipment that are calibrated, employees who are qualified and fully trained and process that are reproducible, are few requirements to assure safety and efficacy.

6. Objectives of cGMP. cGMP’s seek to ensure that all the manufacturer’s of regulated products effectively implement a range of manufacturing controls over the development and manufacture of products, with objective of ensuring that process outputs are of the highest quality and consistently remain so over time. They are broad categories of requirements which a manufacturer must adhere to, however, the specific methods of implementation may vary from one manufacturer to another. For example, there must be document control and document comply with cGMP’s. However each manufacturer will define their own document control and revision process. The regulatory body can then review the effectiveness of these procedures via audit .

7. Objectives of cGMP.

8. Policy Of cGMP The purpose of this policy is to ensure compliance with current good manufacturing practice regulations of foods. It is the responsibility of all the involved personnel at every level of the organisation to act immediately if a risk of violating this policy is detected. Department Managers are accountable for compliance with this policy and the G eneral Manager has final authority concerning any GMP issue.

9. Layout Of Buildings And Services And Equipment. LAYOUT DESIGN ORGANISATION AND PERSONNEL BUILDINGS AND FACILITIES EQUIPMENT PRODUCTION AND PROCESS CONTROL PACKAGING AND LABELING CONTROL

10. Layout Design. The layout design should aim to Minimise the risks of error Permit effective maintenance Avoid cross contamination, build-up of dust and dirt. Avoid any adverse effect on the quality of products . TYPES OF FLOW CIRCULAR FLOW PARALLEL FLOW CROSSOVER TRAFFIC

11. CIRCULAR FLOW.

12. PARALLEL FLOW

13. CROSSOVER TRAFFIC.

14. Organisation And Personnel . The establishment and maintenance of a satisfactory system of QA and the correct manufacture and control of pharmaceutical products and active ingredients rely upon people. chairman Managing director President production President marketing President QA President Finance President personal

15. Personal hygiene

16. Personal Hygiene. All personnel, prior or during employment, as appropriate, should undergo health examination. A personnel must be trained in the practice of personal hygiene. A high level of personal hygiene should be observed by all those concerned with manufacturing processes. Direct contact should be avoided between the operator’s hands and starting materials, primary packaging materials and intermediate or bulk product. Smoking, eating, drinking, chewing and keeping plants, food, drinks, etc. should not be permitted in production laboratory and storage areas. Personal hygiene procedures including the use of protective clothing should apply to all persons entering production area.

17. Buildings And Facilities Any building used in manufacture, processing, packaging or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning maintenance and proper operations. There shall be separate or defined areas or such other control systems for the firm’s operations during the course of the following procedures are necessary to prevent contamination or mix ups. Receipt , identification, storage and withholding from use of components , drug product containers, closures and labelling, pending the appropriate sampling, testing or examination by the quality control unit before release for manufacturing or packaging. Holding rejected components, drug product containers, closures, and labelling; DESIGN AND CONSTRUCTION FEATURES

18. Storage of release components, drug product containers, closures, and labelling; Storage of in p rocess materials; Manufacturing and processing operations; Packaging and labelling operations; Quarantine storage before release of drug products; Storage of drug products after release; Control and laboratory operations; Aseptic processing;

19. Lighting. Adequate lighting should be provided in all areas.

20. Ventilation, air filtration, air heating and cooling Adequate ventilation shall be provided. Equipment for adequate control over air pressure, micro organisms, dust, humidity and temperature shall be provided. Air filtration systems, including prefilters particulate matter air supplies to production areas’ Air handling systems for the manufacture, processing and packaging of penicillin shall be completely separate from those of other drug products of human use.

21. Plumbing – Potable water shall be supplied under continuous positive pressure in plumbing system free of defects that could contribute to contamination to any drug product. Sewage and refuse – Sewage, trash and other refuse in and from the building and immediate premises shall be disposed in safe and sanitary manner. Washing and toilet facilities – Adequate washing facilities shall be provided including hot and cold water, soap detergent, air driers or single-service towels, and clean toilet facilities easily accessible to working areas.

22. Sanitation - A ny building used in the manufacture, processing, packaging or holding of a drug product shall be maintained in clean and sanitary condition. There shall be written procedures assigning responsibility for sanitation and describing in sufficient detail the cleaning schedules, methods, equipment and material to be used in cleaning building and facilities, such written procedures should be followed. Rodenticides, insecticides and fungicides shall be not used unless registered and not used in accordance with the Federal Insecticides, Fungicides, and Rodenticides Act (7 U.S.C. 135)

23. Equipment

24. Equipment design, size and locations- Equipment used in the manufacturing, processing, packing or holding of a drug product shall be of appropriate design, adequate size and suitable location to facilities operation for its intended use and for its cleaning and maintenance . Equipment construction- Equipment shall be constructed so that surfaces that contact components, in process material or drug products shall not be reactive, additives or absorptive so as to alter the safety, identity, strength, quality or purity of the drug beyond the official or other established requirement.

25. Equipment cleaning and maintenance – E quipment shall be cleaned, maintained to prevent contamination. Written procedures shall be established and following for cleaning and maintenance of equipment, used in manufacturing, processing, packing, holding of drug product. Automatic, mechanical and electronic equipment- Computers or related systems, may be used in the manufacturing, processing, packing, and holding of a drug. It such equipment is used, it shall be routinely calibrated, inspected or checked according to written program designed to assure proper performance.

26. Reference Sharma P P , How to Practice GMPs, 7 th edition, Vandana Publication, page no 621-628. Current Good Manufacturing Practices by FDA. http://www.fda.gov/food/guidanceregulation/cgmp/default.htm WHO GMP guidelines by WHO. http://who.int/medicines/areas/quality/safety/qualityassurance/production/en