CGMP.pptx

this is cgmp

1. cGMP AND INDUSTRIAL MANAGEMENT Dhanasekar J M. Pharm 1 st semester Department of pharmaceutics Nandha college of pharmacy 7/14/2023 1

2. CONTENT Introduction Objectives Plant Layout. Services. Equipment’s. Production organization. Materials management. Handling and transportation. Inventory management and control. Production and planning control. Sales forecasting, budget and cost control. Industrial relationship quality. Concept of total management. 7/14/2023 2

3. INTRODUCTION: cGMP - Current Good Manufacturing Practice. The cGMP regulations enforced by the FDA(Food and Drug Administration ). cGMP’s provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. 7/14/2023 3

4. COMPONENTS OF cGMP : GMP is part of QA GMP’s main function is to produce quality products consistently . GMP must meet legal requirement’s of country. GMP must meet both production and QC related issues . 7/14/2023 4

5. ACTIVITES OF cGMP cGMP expects that all the people should be trained. It provides complete guidelines on requirements of facilities and equipment’s. cGMP talks about how you should control the quality of materials at every stage. It also further talk about quality, production systems and their control. 7/14/2023 5

6. OBJECTIVES : 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 cosmetic products, overall control and monitoring. Ensure that the consumer receives products of specified quality. cGMP regulations assure the identify, strength, quality and purity of drug products . The quality of a product depends on the starting materials, production and quality control processes, building, equipment and personnel involved. 7/14/2023 6

7. PLANT LAYOUT: Plant Layout is a co-ordinated effort to achieve the final objective to integrate machines, materials, and personal for economic production. Plant layout involves location of different departments and arrangement of machinery in each department. 7/14/2023 7

8. TYPES OF PLANT LAYOUT : Process layout or functional layout. Product or straight line layout. Process layout or functional layout : Arrangement of machines of a particular class doing a particular process as separate department. Advantages : More effective supervision . Division of labour can be provided. Disadvantages : May not be possible as a number of unit operations have to be performed . 7/14/2023 8

9. PRODUCT OR STRAIGHT LINE LAYOUT : The arrangement of machines doing various operations in a line as one department. Advantages : Processing of work is quick and smooth Cost of handling is reduced using conveyers. Manufacturing time can be reduced. Floor space can be properly utilized. 7/14/2023 9

10. FACTORS INFLUENCING PLANT LAYOUT : Basic managerial policies and decisions. Nature of plant location. Type of industry and process Intermittent Industries. Continuous Industries. Types of methods of production Job Production. Batch/Lot Production. Continues/Mass Production 7/14/2023 10

11. SERVICES : Lighting, Ventilation, Air filtration, Air heating, Cooling, Plumbing, Washing and toilet facilities, Sanitation. These are all services provide in cGMP. ( Current Good Manufacturing Practice ) 7/14/2023 11

12. EQUIPMENT : Equipment shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance. Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive or absorptive. Equipment and utensils shall be cleaned, maintained, and as appropriate for the nature of the drug, sanitized and/or sterilized at appropriate intervals to prevent malfunctions or contamination. 7/14/2023 12

13. TYPES OF EQUIPMENT : Automatic, mechanical, or electronic equipment or other types equipment. Including computers, or related systems that will perform a function satisfactorily. Appropriate controls shall be exercised over computer or related systems. Filters for liquid filtration used in the manufacture processing, or packing of injectable drug products intended for human use shall not release fibres into such products. 7/14/2023 13

14. PRODUCTION MANAGEMENT : Production may be defined as the conversion of inputs in to out put through a transformation process. Input: men, machines, materials, money , methods. Output : goods produced-for manufacturing concern or service rendered- for the service operation units as banks , hospitals. Production Management is viewed as a continuous process of planning, organization and controlling. 7/14/2023 14

15. Planning : It includes all activities that established a course of action. It guides future decision making and involve product planning, facility planning. Organizing : It includes all the activities that establish a structure of tasks and authority. It determines the activities required to achieve the operations and responsibility for carrying them out. Controlling : It includes all the activities that ensure that actual performance is an accordance with the planned performance. 7/14/2023 15

16. MATERIAL MANAGEMENT : Definition : I t is an organizational concept which has the authority & responsibility of all activities, principally concerned with the flow of materials in the organization. Material management works continuously with production, marketing, sales & quality control. It has the responsibility of determining the amount of inventory & its accountability. It is concerned with planning, directing & controlling the kind, amount, location, movement of the various flows of materials used in & produced by a business enterprise. 7/14/2023 16

17. FUNCTIONAL OF MATERIAL MANAGEMENT : Material planning & programming. Simplification, standardization & value analysis. Inventory control & management. Receiving of incoming materials. Storage, preservation & administration of materials. Production planning & scheduling. Disposing of rejects & obsolete materials. Improving operation efficiency through training. 7/14/2023 17

18. FACTORS : Quality : It is defined as the suitability of an item to accomplish the intended purpose. Quantity : The quantity is mainly based on the calculation of Economic order quantity (EOQ). Price : Of materials are negotiated with the firms based on certain procedures. Delivery date : are finalized based on the needs of organization. 7/14/2023 18

19. HANDLING & DISTRIBUTION: Warehousing Distribution The conditions satisfied by the warehousing area are as follow: Good storage condition. Clean and dry. Acceptable temperature limit. Good sanitization. Separate sampling area. Fire Prevention. Properly labelled materials . 7/14/2023 19

20. Storage of drug products should be under appropriate conditions of temperature, humidity, and light. A procedure whereby the oldest approved stock of a drug product is distributed first. Deviation from this requirement is permitted if such deviation is temporary and appropriate. A system by which the distribution of each lot of drug product can be determined to facilitate its recall if necessary. 7/14/2023 20

21. INVENTORY MANAGMENT: Definition : The ‘Inventory’ can be defined as stock of items (includes raw materials, in process goods, finished goods, packaging, & other spares) in order to meet an unexpected demand/distribution in the future. Or Inventory is defined as an itemized list of goods with their estimated worth, specifically, annual account of stock taken in any business. 7/14/2023 21

22. Objectives : To reduce dependence of one another. To enable each organisation schedule its independently of another. To reduce material handling costs. Maximize customer service. Longer production runs. Flexibility in production scheduling. To avoid stock out and shortage. 7/14/2023 22

23. CATEGORY : Production Inventory : Special items manufactured to company specification. MRO Inventory : Maintenance, repair & operating supplies which is consumed in production process. In-Process Inventory : Semi finished products found at various stages in the production operation. Finished Goods Inventory : Complete products ready for shipment. 7/14/2023 23

24. INVENTORY COSTS : Cost factors must be considered while any decision regarding inventories. Includes ordering costs, carrying cost, out of stock/shortage cost and set up cost. Ordering cost, Carrying cost/Holding costs, Out of stock/Storage cost, Cost of item , Set up cost. 7/14/2023 24

25. TECHNIQUES IN INVENTORY MANAGEMENT : ABC Analysis VED Analysis EOQ Analysis Perpetual Inventory System Lead time Buffer Stock 7/14/2023 25

26. ABC Analysis : Always Better Control It is an inventory categorization method used for the analysis of range of items that have different levels of significance and should be controlled differently. VED analysis : This system is based on utility of the material. The different brands of the drug formulation is classified as: V=VITAL ITEMS E=ESSENTIAL ITEMS D=DESIRABLE ITEMS 7/14/2023 26

27. EOQ Analysis : EOQ is the quantity of materials to be ordered at one time, which minimizes the cost. The correct quantity to buy is the quantity at which the ordering and inventory cost is maximum. EOQ = √2AB C A - annual requirement B - ordering cost C – carrying cost 7/14/2023 27

28. Perpetual Inventory system : The method of recording the store balance after every receipt and issue to facilitate checking and to prevent closing down for stock taking. It comprises of : Bin Card Store Ledger Continuous Stock Taking Lead Time : It is the time taken between the placing of order and receipt of drugs to the department. Buffer Stock : It is used in emergency to meet the unseen demands. 7/14/2023 28

29. PRODUCTION AND PLANNING CONTROL : There shall be written procedures for production and planning control designed to assure that the drug products have the identity, strength, quality, and purity they possess or are represented to posses. Written production and process control procedures shall be followed. The batch shall be formulated with the intent to provide not less than 100% of the labelled or established amount of active ingredient. 7/14/2023 29

30. Weighing, measuring, or subdividing operations for components shall be adequately supervised . Each container of component dispensed to manufacturing shall be examined by a second person. Actual yields and percentage of theoretical yield shall be determined at the conclusion. All compounding and storage containers, processing lines and major equipment used during the production of a batch of a drug shall be properly identified. To assure batch uniformly and integrity of drug products, written procedures shall be established ad followed that described the in process controls, and tests, or examinations to be conducted. Written procedures shall be established and followed prescribing a system for reprocessing batches that do not confirm to standards or specifications . 7/14/2023 30

31. SALES FORECASTING : Forecasting is the art of estimating future demand by anticipating what buyers are likely to do under a given set of future conditions. A sales forecasting is a projection into the future of expected demand given a stated set of environmental conditions. 7/14/2023 31

32. Short-term Forecasts : For periods up to 3 months ahead. For tactical matters. The general trend of sales is less important than short-term. Medium-term Forecasts : For 1 year ahead. Of most importance in the area of business budgeting. Long-term forecasts : For periods of 3 years and upwards. Needed mainly by financial accountants for long-term resource implications. 7/14/2023 32

33. BUDGETING : An organization needs to budget to ensure that expenditure does not exceed planned income. The sales forecast is the starting point for business planning activities. Taking the medium-term sales forecast as the starting point the budgets are allocated to departments. Budges are a means of control. 7/14/2023 33

34. TYPES OF BUDGETING: Activity based Rolling Strategic Budgeting Zero Based Budgeting Budget Determination : Departmental manager determines how the overall departmental budget will be utilised in achieving the planned-for sales. The overall sales forecast is the basis for company plans, and the basis for marketing plans in achieving those forecasted sales. The sales department budget is consequently a reflection of marketing forthcoming expenditure in achieving those forecasted sales. 7/14/2023 34

35. SALES BUDGET: Is the total revenue expected from all products that are solid. Comes directly after the sales forecast. Is the starting point of the company budgeting procedure because all other company activities are dependent upon sales and total revenue anticipated from the various procedure that the company sells. 7/14/2023 35

36. INDUSTRIAL RELATION’S : ‘Industry’ refers to “any productive activity in which an individual is (are) engaged”. By ‘ relations ’ we mean “the relationships that exist within the industry between the employer and his workmen”. The Industrial relation relations also called labour -management. Employee employers relations. The term industrial relations explains the relationship between employees and management which stem directly or indirectly from union-employer relationship. Industrial relations are the relationship between employees and employers within the organization settings. 7/14/2023 36

37. PARTIES OF IR: Importance : Uninterrupted production Reduction in Industrial Dispute High morale Reduced wastage Foster Industrial Peace Promote Industrial Democracy. Employees Employers Government Trade Union Employer As s oc i at i on Court & T r i buna l s I ndustr i al Relations 7/14/2023 37

38. Role of Employers : Creating and sustaining employee motivation. Ensuring commitment from Employees. Role of Employees : To redress the bargaining advantages on one-on-one basis. To secure better terms and conditions for their members. To increase implementation of democratic way of decision making at various levels. Role of State : Labour policies Labour laws Wage boards Industrial relations policy. 7/14/2023 38

39. CONCEPT OF TOTAL QUALITY MANAGEMENT : Total quality management(TQM) is a modern approach of the management of the whole organization that emphasizes the role of quality in meeting the needs and expectations of its customers. TQM stresses the need for the whole company to manage quality at every stage of production and interaction with the customer. 7/14/2023 39

40. THE QUALITY HERE FOCUSES IN 3 PERSPECTIVES: Quality of the products and services aligned with customer specifications. Quality or amount of returns to satisfy the stake holder needs. Quality of working conditions internal to the organisation. TQM ensure that the management adopts a strategic overview of the quality & focuses on prevention rather than inspection. 7/14/2023 40

41. REFERENCES : Overview of cGMP requirements. cGMP Regulations – 21 CFR 211 cGMP for Phase 1INDs Laurie P. Norwood. Deputy Director. Division of Manufacturing and Product Quality. Office of Compliance and biologics Quality. How to write Standard Operating Procedures and work Instruction”. David N.Muchemu, Creatspace, October 2010. A primer good laboratory practice and current good manufacturing practice Ludwig Huber Agilent Technologies. FDA Food and Drug Administration. GMP Combination Handbooks. 31 Aug 2008. The Centre for Professional Advancement. Good Manufacturing Practice. 2008. 1 Sep 2008. 7/14/2023 41

42. THANK YOU. 7/14/2023 42