OBJECTIVE AND POLICIES OF CGMP.pptx
- 1. OBJECTIVE AND POLICIES OF CGMP & INVENTORY MANAGEMENT CONTROL PRESENTED BY : MEGHA RAMESH TONGE M PHARM (DEPT OF PHARMACEUTICS ) HI-TECH COLLEGE OF PHARMACY ,CHANDRAPUR
- 2. CONTENT INTRODUCTION IMPORTANCE OF CGMP OBJECTIVES POLICIES OF OF CGMP INVENTORY CONTROL OBJECTIVES FUNCTIONS INVENTORY COST TECHNIQUES OF INVENTORY CONTROL
- 3. CURRENT GOOD MANUFACTURING PRACTICES CGMP refers to the regulation which establish by the US Food and Drug Administration . This assure that drug product meet their quality standard . CGMP provide for system that assure proper design monitoring and control of manufacturing processes and facilities The regulation make sure that the product is safe for use and that it has the ingredients and strength it claim to have . The approval process for new drug and generic drug marketing application include a review of the manufacture compliance with the c GMP . FDA can issue a warning letter or initiate other regulatory action agains a company that’s fails to comply with the regulations
- 4. This includes establishing strong quality management system , obtaining appropriate quality raw material , detecting and investigating product quality deviation and maintaining reliable testing laboratories This formal system controls at a pharmaceutical company if adequataly put into practice , helps to prevent in contamination ,mix –ups ,deviations , failures and errors
- 5. Title 21 of code of federal regulation (CFR) : FOOD DRUG AND COSMETIC ACT The US GMP regulation are divided into two parts : 210 and 211 of title 21 Part 210 : “current good manufacturing practices in manufacturing processing and packing or holding of drugs “ basically it provide the framework for the regulation Part 211 : “current good manufacturing practices for finished pharmaceuticals
- 6. IMPORTANCE OF CGMP It prevent the product mix ups , contamination , deviations , failures and errors which assures that the drug products meets the required quality standard . It assures that the drug are manufacture under good conditions , equipment is properly maintained and calibrated , by who are qualified and fully trained and processes that are reliable and reproducible
- 7. OBJECTIVE OF THE CGMP Ensure that products are consistently manufactured and controlled to the specified quality . Concerned with all aspects of production and quality control In the manufacture of cosmetics products of specified quality Ensure that the consumer receives products of specified quality CGMP regulation assures the identity , strength , quality and purity of drug products
- 8. CURRENT GMP POLICIES Section 1 : PERSONNEL There shall be an adequate number of personnel at all levels having knowledge, skills and capabilities relevant to their assigned functions, in good mental and physical health to be able to execute their duties. The organizational structure of the company shall be such that the production and the quality assurance are headed by different managers like quality control manager, production control manager ect. All employees who are engaged in the manufacturing activities shall be trained properly that the employees perform in accordance with the principles of Current Good Manufacturing
- 9. Section 2 : PREMISES The premises for manufacturing shall be of suitable size , design , construction and location to facilitate proper operation , cleaning and maintenance . The individual working area shall be adequate so that any risk of confusion ,cross- contamination will adversely affect the quality of drugs and devices will be avoided . Production areas shall be ventilated with air control facilities Avoid exposed overhead roof joints , pipes and ducts The condition of buildings shall be reviewed regularly , and repaired where necessary
- 10. Section 3 : EQUIPMENTS Equipment used in the manufacturing of drug products shall be of appropriate design and construction , adequate size . It should be properly installed in order to assure product quality and process reproducibility and to facilitate its cleaning and maintenance Equipment shall be subjected to regular maintenance checks at appropriate intervals to prevent malfunctions or contamination Written procedures shall be established and followed for maintenance of equipment . Validation shall be conducted following a validation protocol
- 11. Section 4 : SANITATION AND HYGIENE The sanitation and and hygiene program cover personnel , premises ,equipment and apparatus , production materials and containers and anything that could become a source of contamination to the product It should be validate and periodically assessed to ensure that the effectiveness of the operation Direct contact shall be avoided between the operator and raw materials ,intermediate or bulk products . Records of cleaning , sanitizing ,sterilization and inspection shall be maintained.
- 12. Section 5 : STORAGE OF STARTING AND PACKAGING MATERIALS AND FINISHED PRODUCTS Materials shall be stored in an order to prevent any risk of mix-up or contamination and to facilitate inspection and maintenance The materials shall be stores under suitable environmental condition All raw material packaging material , intermediate and bulk products return to storage areas shall be properly documented and reconciled. Rejected raw materials and packaging material shall not be store together with approved material The first expiry first out system (FEFO) on approved raw materials shall be used
- 13. Section 6 : PRODUCTION Production shall follow defined procedures capable to provide assurance that drug products to confirm their specification Manufacturing facilities and method shall be design to prevent cross contamination process validation the presence in a drug product of any contaminant is unacceptable . A batch and/or lot numbering system applied to a processing state and finished product Section 7 : PACKAGING Packaging operation shall be performed under strict control to protect the identity , integrity and quality of the final package . All packaging operations shall proceed in accordance with SOP .
- 14. Section 8 : FINISHED PRODUCT QUARANTINE AND DELIVERY TO WAREHOUSE Finished product quarantine is the last point of control before the product enters the warehouse and available for distribution to the market Strick control shall be maintained to ensure that the product and its packaging records meet all specified requirements before release to the warehouse Written procedures should be maintained for the transfer of finished product into the quarantined area ,and subsequent transfer to the finished good warehouse
- 15. Section 9 : QUALITY CONTROL Quality control is an essential part of good manufacturing practices to provide assurance that the products will be consistently of a quality appropriate to their intended use An independent quality control unit shall be established . A quality control system shall be developed to ensure that finished products contain the correct materials of specified quality and quantity and are manufactured under proper conditions following standard procedures Quality control involves all analytical functions conducted in the laboratory , including sampling , inspecting and testing of starting materials , intermediate , bulk and finished product
- 16. Section 10 : DOCUMENTATION Documents shall be prepared and designed carefully for easy , correct and effective use . Documents shall contain records of activities within production, quality control, equipment maintenance, warehouse, distribution and other specific activities related to Good Manufacturing Practices A master production document should include the product name, dosage form, strength and description, the writer’s name and description, name of verifier and list of document distribution. Batch processing Record Master packaging procedure
- 17. Section 11: SELF INSECTION The purpose of self-inspection is to evaluate the manufacturer’s is to evaluate the manufacturer’s compliance with Good Manufacturing practices on all aspects of production and quality control. Self-inspection shall be preformed routinely and corrective actions shall be implemented. A team consisting of personnel who can evaluate the implementation of GMP objectively shall be appointed . The procedure and record for self inspection shall be documented
- 18. Section 12 : GUIDELINE FOR HANDLING OF PRODUCT COMPLAINT , PRODUCT RECALL AND OR RETURNED PRODUCT A product complaint and report may relate to the quality , adverse reaction or other therapeutic effect of the product A follow up action shall be taken after investigation and evaluation of the product complaint and report A product recall is a process of withdrawing one or more batches or all of a certain product from market distribution A returned product is a finished product which is already in distribution and return to the manufacturer due to complaint , damage , expiration , validity or other reason
- 19. INVENTORY MANAGEMENT AND CONTROL Inventory control is the process by which inventory is measured and regulated according to predetermine norms such as safety stock , minimum level ,order level etc Inventory means all the raw materials ,semi processed materials and finished goods etc . Inventory management is essential to maintain a large size inventory for smooth and efficient production and also for sales operation
- 20. OBJECTIVE OF INVENTORY CONTROL To minimise the possibility of disruption in the production schedule for want of raw materials , consumables ,spares and other store item . To keep down the capital investment in the inventories. To ensure adequate stock to finished product to meet the deliver requirement of the customer. To reduce the loss due to changes in prices of inventory items . To facilitate the intermittent production of several products on the same facility . To stabilize employment and improve labour relations by inventory of human resourses and machine efforts.
- 21. FUNCTIONS OF INVENTORY CONTROL Minimise the carrying cost of the materials . Maintenance of sufficient stock of materials to take care of the requirement during the period of short supply . Maintenance of sufficient stock of finished goods for smooth sales operations. Protect the inventory against deterioration , obsolescence and unauthorised use . To keep the inventories as low as possible which leads to consistent price of market conditions . maintain the proper records and assess the stock position of the materials
- 22. INVENTORY COSTS • Cost of ordering the item . • Expenses from raising the indent ,purchaserequisionby user department till the execution of order ORDERING COST • Cost incurred for holding the volume of inventory . • Obsolescence cost , deterioration cost , taxes on inventory, capital cost INVENTORY CARRYING COST • Loss due to non availability of materials • Break down /delay in production ,lost sales ,loss of service to custom OUT OF STOCK COST
- 23. TECHNIQUES OF INVENTORY CONTROL ABC Analysis VED Analysis SOS Analysis XYZ Analysis HML Analysis FSNO Analysis SDE Analysis
- 24. ALWAYS BETTER CONTROLANALYSIS Based on annual inventory values PROCEDURE : List of all material used in the company . Work out their annual consumption value and money value . Multiply each items annual value by its money value . Arrange the item in the descending order Find out each items percentage of the total inventory .
- 25. ADVANTAGES OF ABC ANALYSIS It ensure the better control over costly items. It helps in developing scientific method of controlling inventories . It helps in the maintaining the stock in a better way . Reducing the storage cost DISADVANTAGES OF ABC ANALYSIS Inconvenient to compute when item are in large number . Loose control of itesm causes shortage . Focuses on money value and not on functional importance causing storage of critical items . Does not consider variation of prices with time
- 26. VED ANALYSIS Vital –Essential –Desirable Based on the utility of the material FSN ANALYSIS Fastmoving –slow moving –non moving Based on the quantity ,rate of consumption ,pattern of issue for stores . HML ANALYSIS High value – medium value –low value Based on their unit cost
- 27. XYZ ANALYSIS High stock value –medium stock value –low stock value Based on the value of inventory of materials . GOLF ANALYSIS Government –ordinary –local – foreign Based on availability of nature of suppliers . SOS ANALYSIS Seasonal – off seasonal Based on the seasonality of item
- 28. REFERENCES Current good manufacturing practices guidelines by karn gupta www.youtube.com www.fda.gov .in How to practice GMPs by P.P. Sharma . www.wipo.int>laws Inventory control and management by C.D. J Waters. Metod of inventory controls available at http://www.yourarticlelibrary.com
- 29. Thank You