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Material management

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Material management

  1. 1. MATERIAL MANAGEMENT Presented by: DESAI BHAKTI R. Class: M-pharm ( Sem-I ) Sub: AQAT Guided by: Mrs. S. MAHAPARALE
  2. 2. CONTENTS  Introduction.  Defination.  Objectives.  Functions of Material Management.  Advantages. 1
  3. 3. INTRODUCTION  The prime objective of the pharmaceutical manufacturing operations is to produce finished pharmaceutical products from active, inactive raw materials and various packaging materials.  The quality of finished products produced solely depends upon the quality inputs and hence MATERIAL MANAGEMENT becomes a very important activity in pharmaceutical manufacturing operations.  The total material management activity starts from selection of vendors for raw materials to packaging materials to dispatch of finished products to its destination. 2
  4. 4. DEFINATION  Material managementis a scientific technique, concerned with Planning, Organizing & Control of flow of materials, from their initial purchase to destination.  The scope of material management lies on : 1. Material Planning. 2. Material Obtaining. 3. Material Controlling. 4. Material Storing. 5. Material Handling. 3
  5. 5. OBJECTIVE 1. Maintain steady flow of material. 2. Achieve economy in terms of material. 3. Ensure consistency of quality. 4. Reduction of inventory cost. 5. Conservation of the materials. 6. Minimize operational cost. 4
  6. 6. FUNCTIONS OF MATERIAL MANAGEMENT  The following points should be considered for the pharmaceutical material management: 1. Purchasing. 2. Raw materials. 3. Packaging materials. 4. Intermediate and bulk products. 5. Finished products. 6. Rejected and Recovered materials. 7. Recalled products. 8. Returned goods. 5
  7. 7. 6 9. Reagents and culture media. 10. Waste materials. 11. Reference standards. 12. Miscellaneous materials.
  8. 8. PURCHASING  All materials should be purchased against an approved and adequate specification which defines not only the grade and quality of the materials, but also the nature of the packaging and container to be used.  Materials should be purchased and sourced only from approved suppliers and manufacturers.  Raw materials and Packaging materials should only be purchased by buyers who are trained and who possess sufficient technical knowledge.  DOCUMENT REQUIRED: 1. SOP/R vendor certification. 7
  9. 9. RAW MATERIALS  Supplier/ Manufacturer of the received material should have his name listed in companies approved vendors list. Such list should be available with the receiving department.  All raw materials and other related materials should be checked for following things, after receiving: 1. Name of the manufacturer/supplier. 2. Name of the product. 3. Batch numbers. 4. Date of manufacturer and date of expiry. 5. Quantity received and number of containers. 6. Condition of containers and materials. 8
  10. 10.  All received materials must be properly identified with their status (e.g. received, sampled, approved, rejected, to be returned back, etc.) labels and materials identification like, product name, batch number, code number, sterility status, etc.  Materials in the storage area should be appropriately labelled. Labels should bear atleast the following information: 1. The name and internal code number of the product. 2. The batch number. 3. Status of the material. 4. Retest and expiry date of the product. 5. Appropriate special storage conditions.  Containers from which samples have been taken out should be identified. 9
  11. 11.  Each dispensed material and its weight or volume should be independently checked and the check recorded.  DOCUMENT REQUIRED: 1. List of approved vendors with materials. 2. List of materials classified according to storage conditions. 3. SOP on sampling, storage and dispensing of materials. 4. Register of sampling and dispensing activities. 10
  12. 12. PACKAGING MATERIALS  Packaging materials are divided into following categories: 1.Primary Packaging Materials: Materials which come in direct contact with the medicinal product. E.g. bottles, ampoules, vials, foils, etc. 2.Secondary Packaging Materials: Materials which come in contact with the primary packaging materials, e.g. labels, carton etc. 3.Printed Packaging Materials: All packaging materials which have any thing printed on it; even error medical literature sent along with finished product is also put in this category. Such materials include labels, cartons, foils, etc. 11
  13. 13. 4. Tertiary and other Packaging Materials: All other packaging materials other than those covered in the above three categories.  While handling all these materials following points should be kept in mind. 1. The purchase, handling and control of primary and printed packaging materials shall be as for raw materials. 2. Access to all storage areas should be limited to authorised personnel only. 3. A separate sampling room should be provided for sampling of primary packaging materials, which should be a fairly clean area.  DOCUMENT REQUIRED: 1. A list of approved vendors along with names of materials. 2. Sampling and dispensing register in chronological order. 3. A list of materials based on their storage conditions. 12
  14. 14. INTERMEDIATE AND BULK PRODUCTS  Intermediate and bulk product storage is the responsibility of the production department.  Intermediate or bulk product may be defined as the material, which has started processing but not yet got converted into the finished saleable product e.g. 1. Granulated materials ready for compression. 2. Compressed tablets for coating or packaging. 3. Filtered or unfiltered liquids for oral or injectable etc.  These products should be kept under appropriate storage conditions of temp, relative humidity, class of air etc. 13
  15. 15.  Intermediate or bulk products purchased as such should be handled on receipt as though they were raw materials.  DOCUMENT REQUIRED: 1. List of categories of intermediate and bulk products along with their storage conditions. 2. Other requirements if any e.g. how much time such materials can be stored for further processing etc. 14
  16. 16. FINISHED PRODUCTS  Finished products are products which are in the marketable pack.  These products should be held in quarantine until their final release,after which they should be stored as usable stock under conditions established by the manufacturer.  Each batch of the finished product should be tested as per laid down testing procedure against its specifications and then only released for distribution or sale.  DOCUMENT REQUIRED: 1. SOP on releasing of the finished product. 2. SOP on reprocessing of rejected finished product. 15
  17. 17. REJECTED AND RECOVERED MATERIALS  Rejected materials may be defined as materials at any stage, which have been tested against a set of predefined specifications and found not meeting the specification fully.  We can deal with such materials mainly in two ways: 1. Reprocess and retest the materials to see whether it meets our specific requirements. 2. Destroy or send it to the supplier.  Rejected materials and products should clearly marked as such and stored separately in restricted areas. 16
  18. 18.  Such areas in industry are normally painted RED in colour to make it distinguishable easily.  Such materials should either be returned to the suppliers or reprocessed or destroyed.  Rejected production batches should be reprocessed in exceptional situations.  Reprocessed batches should be given a new number by means of which, such batches can be identified as reprocessed batches.  DOCUMENT REQUIRED: 1. SOP on handling of rejected materials. 2. Record of disposal of rejected materials. 3. SOP on handling of recovered materials. 4. Record of disposal of recovered materials. 17
  19. 19. RECALLED PRODUCTS  Products, which are already distributed or sold, may be required at times to be recalled from market for various reasons e.g. substandard quality detected after the product was distributed, damage of goods during transit.  Such recalled products should be clearly identified and stored separately in a secure area until a decision is taken on their fate.  DOCUMENT REQUIRED: 1. SOP on handling of recalled products. 2. Records of recalled products and action taken on such recalled products. 18
  20. 20. RETURNED GOODS  Pharmaceutical products can be returned from the market for various reasons. E.g. quality problems, accidental damage of goods etc.  Such products when returned from the market should have the following action immediately taken on it. 1. Physically examine the condition of the goods returned. Also check all the relevant documents. 2. Ask Q.C department to evaluate the quality of the goods received, and take a decision on whether these products can be reprocessed and recovered or needs to be destroyed. 19
  21. 21.  If it is possible to reprocess and recover, then such products after reprocessing and retesting may be considered for relabelling, repacking and resaling the same.  Q.C. department should evaluate all aspects like condition of the received material, time elapsed since it was first processed etc. along with the chemical, microbiological or any other technical evaluations.  Any action taken should be recorded.  DOCUMENT REQUIRED: 1. SOP/R on handling of returned goods. 20
  22. 22. REAGENTS AND CULTURE MEDIA  All reagents and culture media should be recorded upon receipt or preparation.  Reagents made up in the laboratories should be prepared according to written procedures and appropriately labelled. Such labels should indicate following information viz. a) Name of the reagent. b) Nominal concentration (e.g. 1 N, 0.1 N etc.). c) Standardisation factor (1N=0.996 N etc.). d) Shelf life ( or use before date). e) Date when re-standardisation is required. f) The storage conditions. 21
  23. 23.  A register be maintained giving details of the reagents made, standardised, restandardised and used and destroyed if any.  Both positive and negative controls should be applied to verify suitability of the culture media.  The size of the inoculum used in positive controls should be appropriate to the sensitivity required.  DOCUMENT REQUIRED: 1. Register of reagents and culture media. 22
  24. 24. WASTE MATERIALS  The waste materials can be classified mainly in two categories: 1. Trash : which do not have any resale value and may be disposed off by proper method depending upon the nature of the trash. 2. Scrap : which do have a resale value and may be sold to scrap dealers, after proper segregation.  Toxic substances and flammable materials should be stored in suitably enclosed cupboard, as required by national legislation.  Waste materials should not be allowed to accumulate. 23
  25. 25.  It should be collected in suitable containers for removal to collection points outside the buildings, and disposed off safely and in a sanitary manner at regular intervals.  Before disposal of these materials, they can be segregated in different categories: 1) Paper 2) Aluminium foils 3) Plastic 4) Glass 5) Metallic containers etc.  DOCUMENT REQUIRED: 1. SOP and Records of handling waste work materials. 24
  26. 26. REFERENCE STANDARDS  Reference standards may be available in the form of official reference standards.  Reference standards prepared by the producer should be tested, released and then stored in the same way as official standards.  They should be kept under the responsibility of a designated person in a secure area.  Official reference standards should be used only for the purpose described in the appropriate monograph.  All such reference standards should be stored and used in a manner that will not adversely affect their quality.  DOCUMENT REQUIRED: 1. SOP and Records on handling of reference and working standards. 25
  27. 27. MISCELLANEOUS MATERIALS  All those materials, which do not specifically fall under the category of raw materials and packaging materials, intermediates, bulk and finished pharmaceuticals may be considered under this category of miscellaneous materials.  Such materials like,rodenticides, insecticides, fumigating agents and sanitising materials fall under this category, these materials should not be permitted to contaminate equipment, raw materials, packaging materials, inprocess materials or finished products.  DOCUMENT REQUIRED: 1. List of miscellaneous materials handled in pharmaceutical plants. 2. SOP on handling of miscellaneous materials. 26
  28. 28. ADVANTAGES OF MATERIAL MANAGEMENT 1) Reducing the overall costs of materials. 2) Better handling of materials. 3) Reduction in duplicated orders. 4) Materials will be on site when needed and in the quantities required. 5) Improvements in labour productivity. 6) Improvements in project schedule. 7) Quality control. 8) Better field material control. 9) Better relations with suppliers. 10) Reduce storage of materials on site. 11) Stock reduction, purchase savings and better cash flow management. 27
  29. 29. REFERENCE 1. Manohar A. Potdar, “Pharmaceutical Quality Assurance”, Nirali Prakashan, Fourth Edition : April 2015, page no: 4.1-4.18. 2. J.R. Tony Arnold, Stephen N. Chapman, “ Introduction to Material Management”, Pearson Publication, Sixth Edition, page no: 2-10. 28

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