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Objectives and policies of cGMP & Inventory management and control



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Objectives and policies of cGMP & Inventory management and control

  3. 3. CURRENT GOOD MANUFACTURING PRACTICES  CGMP refers to the regulations given by the USFDA under the authority of Food Drug and Cosmetic act  CGMPs provides the system that assure proper design, monitoring, and control of manufacturing processes and facilities.  This assures the identity strength, quality and purity of drug products by requiring that manufactures of medications adequately control manufacturing operations.
  4. 4. TITLE 21 of Code of federal regulations (CFR) - Food Drug and Cosmetic Act Current good manufacturing practices in manufacturing process is packing and holding of drug. 21CFR210 • Current GMP for finished pharmaceuticals.21CFR211
  5. 5. IMPORTANCE OF CGMP  It prevents the incidents of product mix up, contamination, deviations, failures, and errors which assures that the drug products meet the required quality standards.  It assures that the drugs are manufactured under good conditions, equipment is properly maintained and calibrated, by who are qualified and fully trained and processes that are reliable and reproducible
  6. 6. OBJECTIVES 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 cosmetic products of specified quality  Ensure that the consumer receives products of specified quality.  CGMP regulations assures the identity, strength, quality, and purity of drug products
  7. 7. 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 etc.  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
  8. 8. 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 areas 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
  9. 9. Section 3: EQUIPMENT  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
  10. 10. Section 4: SANITATION AND HYGIENE  The sanitation 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 validated 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.
  11. 11. 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 stored under suitable environmental condition  All raw materials, packaging materials, intermediate and bulk products returned to storage areas shall be properly documented and reconciled.  Rejected raw materials and packaging materials shall not be stored together with approved materials  The First Expiry First Out system (FEFO) on approved raw materials shall be used.
  12. 12. Section 6: PRODUCTION  Production shall follow defined procedures capable to provide assurance that drug products to conform their specification  Manufacturing facilities and methods shall be designed 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
  13. 13. Section 7: PACKAGING  Packaging operations 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 a SOP.  Coding of components shall take place in an area isolated from other packaging operations  Written in-process control procedures shall be followed.
  14. 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.  Strict controls 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 goods warehouse.
  15. 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 products
  16. 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 Practice  A master production document should include the product name, dosage form, strength and description, the writer’s name and department, name of verifier and list of document distribution.  Batch Processing Record  Master packaging procedure
  17. 17. Section 11: SELF INSPECTION  The purpose of self-inspection is to evaluate the manufacturer’s compliance with Good Manufacturing Practices on all aspects of production and quality control.  Self-inspection shall be performed routinely and corrective actions shall be implemented.  A team consisting of personnel who can evaluate the implementation of Good Manufacturing Practices objectively shall be appointed.  The procedure and record for self-inspection shall be documented
  18. 18. Section 12: GUIDELINES 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 returned to the manufacturer due to complaint, damage, expiration, validity or other reasons.
  19. 19. INVENTORY MANAGEMENT AND CONTROL  Inventory control is the process by which inventory is measured and regulated according to predetermined norms such as economic lot size for order or production, safety stock, minimum level, maximum level, order level etc..  Inventory means all the raw materials, semi processed 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. 20.  To minimise the possibility of disruption in the production schedule for want of raw materials, consumables, spares and other store items.  To keep down the capital investment in inventories.  To ensure adequate stock of 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 resources and machine efforts. OBJECTIVES OF INVENTORY CONTROL
  21. 21.  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 unauthorized 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. FUNCTIONS OF INVENTORY CONTROL
  22. 22. INVENTORY COSTS ORDERING COST • cost of ordering the item  Expenses from raising the indent, Purchase requisition by user department till the execution of order INVENTORY CARRYING COST • Costs incurred for holding the volume of inventory  Obsolescence cost, Deterioration cost, Taxes on inventory, Capital cost OUT OF STOCK COST • Loss due to non availability of material • Break down/delay in production, lost sales, loss of service to custom
  23. 23. ECONOMIC ORDER QUANTIY(EOQ)  It is the technique of ordering materials whenever stock reaches the reorder point.  It deals when the cost of procurement and handling of inventory are at optimum level and total cost is minimum.  In this technique, the order quantity is larger than a single period’s requirement so that ordering cost and holding cost balance out.  EOQ=√2DS/H D- demand S- cost of placing the order H- annual holding and storage cost per unit of inventory
  24. 24. Minimum stock level Maximum Stock Level Reorder Level Safety Stock Lead Time(servicing lead time, Supplier’s lead time) Reserve Stock TERMINOLOGIES RELATED TO INVENTORY CONTROL
  26. 26. ABC ANALYSIS Always Better Control Based on the annual inventory values
  27. 27. PROCEDURE FOR ABC ANALYSIS List of all materials used in the company Work out their annual consumption value and money value Multiply each item’s annual value by its money value Arrange the items in the descending order find out each item’s percentage of the total inventory
  28. 28.  It ensures the better control over costly items  It helps in developing scientific method of controlling inventories  It helps in maintaining the stock in a better way  It helps in reducing the storage cost  It helps in maintaining enough stocks of group A, B, and C items ADVANTAGES OF ABC ANALYSIS
  29. 29.  Inconvenient to compute when items are in large numbers  More chance of deterioration of item of class C when it is purchased in bulk  Loose control on C items causes shortages  Focuses on money value and not on functional importance causing shortage of critical items  Does not consider variation of prices with time DISADVANTAGES OF ABC ANALYSIS
  30. 30. VED ANALYSIS  Based on the utility of the materials. VITAL • Ventilator • Morphine • Adrenaline injection • V belts • bearings ESSENTIAL • Anti malarial • Sedatives • Thermometer • Flow meters • Stand by powerset DESIRABLE • Cetrizine • Syringes • Vitamins • Analgesics • Other equipments
  31. 31. COMBINATION OF ABC AND VED ANALYSIS CATEGORY V- ITEMS E- ITEMS D- ITEMS A. ITEMS Constant control and regular follow up, AV Moderate stocks, AE nil stocks, AD B ITEMS Moderate stocks, BV Moderate stocks, BE Low stocks, BD C ITEMS High stocks, CV Moderate stocks, CE Very low stocks, CD
  32. 32. FSN ANAYSIS  Based on the quantity, the rate of consumption, pattern of issues from stores FAST MOVING SLOW MOVING NON- MOVING • Crocin • Digene • Becosules • Cifran • Brufen • Actilase injection • Terlipressin
  33. 33. HML ANALYSIS  Based on their unit cost HIGH VALUE MEDIUM VALUE LOW VALUE
  34. 34. XYZ ANALYSIS  Based on the value of inventory of materials X • High stock value • X ray film, blood bag Y • Medium stock value • ECG recording paper, fistula needle Z • Low stock value • ECG jelly, syringes
  35. 35. GOLF ANALYSIS  Based on the availability and nature of suppliers GOLF govern ment ordinary local foreign
  36. 36. SDE ANALYSIS  Based on their availability of the item or the length of its lead time DIFFICULT
  37. 37. SOS ANALYSIS  Based on the seasonality of items SEASONAL OFF- SEASONAL
  38. 38. REFERENCE  www.fda  How to practice GMPs by P.P Sharma, pageno.105-284  Current Good Manufacturing Practice Guidelines for drugs available at https:>laws  Inventory control and management by C. D. J waters.  Methods of inventory control available at http://www.  Tom Jose V, Akhilesh Jayakumar, , analysis of inventory control techniques, International Journal Of Scientific And Research Publications, Volume 3

Editor's Notes

  • strong quality managements, obtaining appropriate quality raw materials, detecting and investigating product quality deviations and maintaining the reliable testing laboratories.
  • registered qualified pharmacist or any other related profession, experience, duties and responsibilities of all employees shall be clearly defined,
  • . Doors that lead from production areas directly to the outside, e.g. fire exits, shall be secured against contamination
  • Avoids the cross contamination, alter the strength, safety, identity, quality, or purity of the product , sops
  • apparent illness or open lesions that may adversely affect the quality of products shall not be allowed to handle raw materials, packaging materials.separate clothing
  • checked for proper identity, condition of container and approval of quality . Proper records
  • packaging materials, intermediate products and bulk products which are approved by quality control can be dispensed.

  • Total annual cost=annual purchase cost+ annual holding cost+ annual ordering cost
  • The stock level at which an order should be placed. . Over stocking of goods . time interval between the placing the order for the materials are actually received in the stores, : Excess usage requirement during normal lead time
  • cover 10% of the total inventories and consumes about 70% of total budge trequire strict monitoring and maximum follow up,
    safety stocks or low safety stocks
  • in controlling and maintain the stock of various spare parts or raw materials
  • the issues of items in past two or three years are considered. The last date of receipt of the items or the last date of the issue of items whichever is later is considered. helps to avoid investments in non-moving or slow-moving items. helpful in facilitating timely control.
  • Similar to abc analysis instead of consumption, listed in the descending order of unit value and is up to the management fix the limits for 3 categories.
  • Study taken up once ina year during annual stock taking, calculated by dividing an item’s current stock value by the total stock value, helps in identifying the items which are extensively stocked10% number of items are stored, accounting for 70% of the total inventory value
  • The nature of the suppliers will determine the quantity and continuity of supply, lead time payment terms and clerical processing cost and time
  • to buy seasonal items at low prices and keep inventory or buy at high price during off season.
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