Current Good Manufacturing Practices.pptx

Current Good Manufacturing Practices

1. Current Good Manufacturing Practices Presented by Guided by Ms. Sakshi Ravankar Prof. Satish Shelke

2. Contents Organization and Personnel Training Hygiene Design Construction and Plant Layout Maintenance Sanitation Environmental Control Utilities and Maintenance of sterile areas

3. Quality Control ( LABORATORY BASED) Operational laboratory techniques & activities that are used in place to find and correct problems Quality Assurance (COMPANY BASED) Planned and organized activities necessary to provide adequate confidence that a product will satisfy the requirements for quality. Organization

4. General Manager Structure of Organization Sales Manager Operations Manager Purchasing Manager Quality control Supervisor Production manager Department Supervisors Sales Representative Quality control inspection Production Planning

5. Organization of the QC department is divides into Quality Control – All inspection and testing. Quality assurance- All systems and procedures including batch review and audit. Functions Quality must be a prime consideration in the research and development of the medicine to assure safety and efficacy.

6. Personnel Objective To review general issues related to personnel. To review requirements for key personnel. To review the training of personnel. To consider some specific issues. Principle Establishment and maintenance of satisfactory system of QA. Must be sufficient qualified personnel to carry out tasks. Written job descriptions. All personnel should be aware of the principles of GMP that affect them

7. Key Personal Key personnel responsible for supervising the manufacture and quality control of pharmaceutical products should possess the qualifications of a scientific education and practical experience required by national legislation. Their education should include the study of an appropriate combination of: chemistry (analytical or organic) or biochemistry chemical engineering microbiology pharmaceutical sciences and technology pharmacology and toxicology physiology

8. Key personnel include The head of Production The head of Quality Assurance The head of Quality Control

9. Responsibilities of the Head of the Production Department To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality. To approve the instructions relating to production operations and to ensure their strict implementation . To ensure production evaluated and signed by authorized person before sent QC department. To check maintenance of premises and equipment.

10. Responsibilities of the Head of the QC Department To approve or reject starting material, packaging material, intermediate bulk and finished product. To evaluate batch records. To ensure that all necessary testing is carried out. To approve specification, sampling instruction, test method. To approve and monitor analysts. To check maintenance of premises and equipment. To ensure appropriate validation.

11. Responsibilities of the Head of the QA Department Responsible for Leading and directing the QA leadership team. Provide leadership and technical expertise within Test Automation and Quality Assurance. Be accountable for the test automation projects, mentor, and provide leadership to the QA automation developers and managers .

12. Training Trained personnel= Quality performance= Continual improvement Types of Training Initial training, Continuous training, Competency Training program that includes 1)Evaluation of training needs 2) Provision of training needs 3) Evaluation of effectiveness of training 4) Documentation of training and/or re-training 5) Developing, maintaining, and administering the facilities training plan 7) Personnel working in areas where containing hazard

13. Personal Hygiene These procedures should be understood and followed in a very strict way by every person whose duties take him into the production and control areas. It must be the manufacture’s responsibility that there are instructions ensuring that health conditions that can be of relevance to the quality of products come to the manufacture’s knowledge. Steps should be taken to ensure as far as is practicable that no person affected by an infectious disease or having open lesions on the exposed surface of the body is engaged in the manufacture of medicinal products. Every person entering should wear protective garments into the manufacturing areas.

14. Eating, drinking, chewing, or smoking or the storage of food, drink, smoking materials or personal medications is strictly prohibited into the production and storage areas. Personnel should be instructed to use the hand -washing facilities. Direct contact should be avoided between the operator’s hands and the exposed products as well as with any part of the equipment that comes into contact with products. In general, any unhygienic practice within the manufacturing area or in any area where the product might be adversely affected, should be for.bidden

15. Personal Records A Typical Documentation Structure QUALITY MANUAL ↓ PROCEDURES ↓ WORK INSTRUCTIONS ↓ FORMS ↓ RECORDS Purpose of Personal Records It helps to supply crucial information to manages regarding the employees It helps the managers in framing various training and development programmes on the basis of present scenario It helps the government organizations to gather data in respect to rate of turnover, rate of absenteeism and other personnel matters It helps the managers to make salary revision, allowance, and other benefits related to salaries

16. Drug Industry Location The location, environment, plant layout, design and construction of premises directly or indirectly affect the quality of pharmaceuticals, thus play role a significant role in pharmaceuticals. Therefore, a thorough analysis of the selection of location of premises, environment, plant layout, design & construction of premises should be done. The location for the construction of a pharmaceutical plant should be appropriately selected as it determines the balancing of investment & profit. While selecting the location of premises, one should consider both the external and the internal environment .

17. Factors Affecting Location Availability of water, power, fuel, sewage, and waste-stream removal Applicable laws Proper space for future expansion Accessibility for employees, materials, and visitors Environmental issues, like water and air quality, etc. Nearness of undesirable activities that can pollute or act as a source of microbial contamination Availability of suitable labor force Availability of proper security arrangements Accessibility to inter-related operations of the company Political situations like government stability, trade policies and taxation

18. Design and Construction The buildings, used for the factory shall be designed, constructed, adapted and maintained to suit the manufacturing operations so as to permit 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, progressing, warehousing, packaging labeling and testing purposes shall be:

19. Compatible with other drug manufacturing operations. Proper space for working should be there. Proper logically placement of equipment and material. Avoid the risk of mix-up between different categories of drugs or with raw materials, intermediates and in-process materials. Control the cross contamination by other drugs or substances. Design should such that if prevent the entry inserts and rodents. Interior surface (Wall, floors, and ceilings) shall be smooth and free from crack, and permit easy cleaning, painting and disinfection. Provide with adequate lighting and ventilation, if necessary air conditioning to maintain a satisfactory temperature. The interior surface shall not shed particles. A periodical record of cleaning and painting of the premises shall be maintained. It should be proper underground drainage system in the processing areas as far as possible. Sanitary fitting and electrical should be concealed

20. Plant Layout Arrangement of physical facilities such as Machinery Equipment Furniture within the factory building in such a manner so as to have quickest flow of material at lowest cost & with the least amount of handling in processing the product from the receipt of material to the shipment of finished product.

21. Weighing One of the most crucial equipment in Pharmaceutical Industry is Weighing machines Processing The various components of a drug brought together through a step by step process. Filling It is the performance of an aseptic manufacturing procedure Packaging It is the packages and packaging of Pharmaceutical products Shipping Transport to market place. Types of Layouts Product or line layouts Process or functional layouts Fixed position or location layouts Combined or group layouts Cellular layout

22. Maintenance Many problem involved in maintenance due to the facility design and layout of plant and equipment. Sufficient space and facilities for maintenance work must be provided in plant layout. It is essential to consider maintenance regulations while making decisions on equipment. Schedule and procedures must be established for the preventive maintenance of equipment. Written procedures must be established for the cleaning and its subsequent release for use in manufacturing. Equipment and utensils must be cleaned, stored and whenever appropriate sanitized or sterilized to prevent contamination or carry over. Non-dedicated equipment must be cleaned between productions of different materials to prevent cross contamination.

23. Sanitation It consist of three things: ➢ Sanitary condition ➢ Maintenance ➢ Disposal of sewage and refuse Manufacturing area should not be used for any other purpose. It should be maintained clean, orderly manner and free from accumulation waste, dust, debris etc . Eating, chewing smoking or any unhygienic particles should not permitted in manufacturing area . Production areas shall be well lit, particularly where visual on-line controls are carried out. A routine sanitation program shall be drawn up and observed, which shall be properly recorded which includes- 1) Specific areas to be cleaned and cleaning intervals 2) Cleaning procedure to be followed, including equipment and materials to be used for cleaning 3) Personnel assigned to and responsible for the cleaning operations

24. Environmental Control Thermal Pollution and control Various off stream cooling system are required to handle thermal discharge from process There different ways for controlling thermal pollution 1.Wet cooling towers 2. Dry cooling towers Air Pollution Control There are two major categories 1.Those suitable for removing particulate matter Those associated with removing gaseous pollutant Removed by chemical and physical way Water Pollution Control There is a great problem to handling a liquid waste effluent is more complex then gas effluent The treatment could be done by Physical treatment Chemical treatment Biological treatment

25. Utilities and Maintenance of Sterile Areas For sterile drugs separate enclosed area specially designed for the purpose shall be provided. Area shall be provided with air locks for entry and shall be essentially dust free and ventilators with air supply. For all areas where aseptic manufacture has to be carried out air supply shall be filtered through HEPA filters and shall be at a pressure higher than in the adjacent area. Routine microbial counts of all sterile area shall be carried out during manufacturing operation. Area where manufacturing process is going on that area must not be occupied by access people. Special procedures should be followed for entering and leaving the manufacturing area

26. Control Contamination Contamination control is most important part of the pharmaceutical manufacturing because contamination is everywhere in the atmosphere and a little carelessness can contaminate the pharmaceutical product. One of the most critical aspects of dosage form manufacture is the vigilance and care required ensuring the complete absence of any form of cross-contamination. Contamination may occur at any stage of the manufacturing process. Personnel, equipment, area and raw materials all may have contamination that can contaminate the whole batch.

27. References file:///C:/Users/91976/Downloads/IGNTU-eContent-288766925864-B.Pharma-6-SabyasachiMaiti-PharmaceuticalQualityAssurance https://www.slideshare.net/MansiChauhan98/drug-industry-location-designpptx-251452512 https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations cGMP by Dr. Manohar A. Potdar

28. Thank You