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  2. 2. INTRODUCTION <ul><li>Document is a written report or record that provides information especially of an official or legal nature. </li></ul><ul><li>Documentation is a method of preparing a written material, which describe the process in terms of specification, instructions etc. </li></ul>
  3. 3. Drug and cosmetic rules… <ul><li>The drugs and cosmetic rules under the “conditions of licenses” and under schedule M require a manufacturer of drugs to maintain various records. </li></ul>
  4. 4. What documentation system consists…? <ul><li>Written specification </li></ul><ul><li>Descriptions </li></ul><ul><li>Procedures </li></ul><ul><li>Instructions </li></ul><ul><li>Observation/execution data. </li></ul>
  5. 5. Importance of Documentation <ul><li>It provides necessary working details. </li></ul><ul><li>Reduces the risk of mistake. </li></ul><ul><li>Help in tracing the deviation from the expected yield. </li></ul><ul><li>They help in decreasing the batch to batch variation so that quality of product is kept within the limits of acceptability. </li></ul><ul><li>Considered as the history of batch operations. </li></ul><ul><li>Self-inspection of procedure. </li></ul><ul><li>*** Documentation and records are essential for obtaining accreditation, certification of ISOs and approvals by Federal Bodies . </li></ul>
  6. 6. Documentation-Important Areas <ul><li>Particulars with respect to their storage, stability and handling. </li></ul><ul><li>Instruction for all manufacturing and packaging procedure. </li></ul><ul><li>Instruction for non-product related operations. </li></ul><ul><li>Procedure for testing. </li></ul><ul><li>Specification of starting materials, packing materials and products for the compliance by the quality control department. </li></ul>
  7. 7. MASTER FORMULA RECORDS <ul><li>Master formula records are defined as written procedure that give the complete description of all aspects of its manufacture, packing and control with an infection to ensure the purity, identify, quality and strength of each dosage unit through its shelf life. </li></ul><ul><li>It includes the following information, </li></ul><ul><li>Specifying a fixed formulation </li></ul><ul><li>Identifying quality criteria for components </li></ul><ul><li>Providing a set of manufacturing instruction in clear terms </li></ul><ul><li>Describing systematic sampling procedures </li></ul><ul><li>Listing precise assays, tests etc. </li></ul><ul><li>Establishing methods for ensuring complete accountability for all materials Including packing and labelling. </li></ul>
  8. 8. Types of Master Formula Records <ul><li>The master formula records give proportion of ingredients in the formulation. </li></ul><ul><li>Master batch formula records, which specify absolute amounts of specific potent ingredients and excipients. </li></ul>
  9. 9. MASTER PRODUCTION AND CONTROL RECORDS <ul><li>Master production and control records are defined as detailed written instructions including all operations starting from dispensing of raw materials till finishing of bulk products and packaging operation of a particular product. </li></ul><ul><li>Master production and control record includes batch size, date of manufacture and full signature (hand written) by one person and further independently checked, dated and signed by second person. </li></ul>
  11. 11.
  12. 12. BATCH PRODUCTION AND CONTROL RECORDS <ul><li>Batch production and control records shall be prepared for each batch of drug product produced and shall include complete information relating to the production and control of each batch. </li></ul><ul><li>These records shall include: </li></ul><ul><li>(a) An accurate reproduction of the appropriate master production or control record, checked for accuracy, dated, and signed; </li></ul><ul><li>(b) Documentation that each significant step in the manufacture, processing, packing, or holding of the batch was accomplished. </li></ul>
  13. 13. BATCH PRODUCTION AND CONTROL RECORDS <ul><li>Dates; </li></ul><ul><li>Identity of individual major equipment and lines used; </li></ul><ul><li>Specific identification of each batch of component or in-process material used; </li></ul><ul><li>Weights and measures of components used in the course of processing; </li></ul><ul><li>In-process and laboratory control results; </li></ul><ul><li>Inspection of the packaging and labeling area before and after use; </li></ul><ul><li>A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing; </li></ul><ul><li>Complete labeling control records, including specimens or copies of all labeling used; </li></ul><ul><li>Description of drug product containers and closures; </li></ul><ul><li>Any sampling performed; </li></ul><ul><li>Identification of the persons performing and directly supervising or checking each significant step in the operation; </li></ul><ul><li>Any investigation made according to. </li></ul><ul><li>Results of examinations made in accordance with. </li></ul>
  14. 14. RAW MATERIALS <ul><li>The schedule U to the drugs and cosmetic rules require following particulars to be shown in the raw material records:- </li></ul><ul><li>Date of receipt, </li></ul><ul><li>Invoice number, </li></ul><ul><li>Name and address of manufacturer/supplier, </li></ul><ul><li>Batch number, </li></ul><ul><li>Quantity received </li></ul><ul><li>Pack size, </li></ul><ul><li>Date of manufacture, </li></ul><ul><li>Date of expiry </li></ul><ul><li>Date of analysis and release/rejection by quality control, </li></ul><ul><li>Analytical report number, </li></ul><ul><li>Quantity issued, </li></ul><ul><li>Date of issue, </li></ul><ul><li>Name and batch number of the product for manufacture of which issued, </li></ul><ul><li>Proper disposal of stocks </li></ul>
  15. 15. FORMAT Name of the material: RECEIPT ISSUE/DISPOSAL Date of receipt Invoice number & date Name & Address of supplier Qty Recd (pack size) B. No. Mfg date Exp date Name & Address of manufacturer Opinion Of Q.C. Dept QC Report No.& Date Date Of Issue Qty issued Name & B. No. of product for which issued Balance Particulars of disposal if not used Sign of issuing person
  16. 16. Labels and printed packaging material records <ul><li>The Indian GMPs require the records of labels and printed packaging materials indicating receipt, examination relating to testing and whether accepted or rejected to be maintained. </li></ul><ul><li>Labels </li></ul><ul><li>What must be labelled? </li></ul><ul><li>-Containers, equipment, premises, products, intermediates, samples, standards etc. </li></ul><ul><li>-Status (quarantined, accepted, rejected, clean) </li></ul><ul><li>Who has responsibility for labelling? </li></ul><ul><li>-QC and production for status labels </li></ul><ul><li>-Final product, intermediates, reagents etc. </li></ul>
  17. 17. Drug product container, closure, and labelling records . <ul><li>These records shall include the following: </li></ul><ul><li>The identity and quantity of each shipment of each lot of components, drug product containers, closures, and labelling. </li></ul><ul><li>The results of any test or examination performed. </li></ul><ul><li>An individual inventory record of each component, drug product container, and closure and, for each component, a reconciliation of the use of each lot of such component. </li></ul><ul><li>Documentation of the examination and review of labels </li></ul><ul><li>The disposition of rejected components, drug product containers, closure, and labelling. </li></ul>
  18. 18. Drug product container, closure, and labelling records . Name of the material: RECEIPT ISSUE /DISPOSAL Date of receipt Qty received Invoice No Date, name &address Consignment number Opinion of Q.C Q.C. report No & date Date Of issue Qty issued Batch .No for which issued balance Particulars of disposal if not used Sign of issuing person
  19. 19. QUALITY CONTROL RECORDS: <ul><li>The quality control records must show: </li></ul><ul><li>The date of performance of test; </li></ul><ul><li>Identification of material; </li></ul><ul><li>Name of supplier(in case of raw materials) </li></ul><ul><li>Date of receipt </li></ul><ul><li>Batch number </li></ul><ul><li>Quantity received (in case of raw materials) (batch size in case of finished product) </li></ul><ul><li>Date and quantity of sample taken </li></ul><ul><li>Specifications employed for testing </li></ul>
  20. 20. <ul><li>All data secured in the course of each test including all graphs, charts, printouts etc </li></ul><ul><li>Calculations performed in connection with including units of measures, conversion factors and equivalence factor </li></ul><ul><li>A statement of the result of tests and how the results compare with established standards of identity, purity and strength </li></ul><ul><li>The initials or signature of person who performs the tests </li></ul><ul><li>Certificate number issued </li></ul><ul><li>Disposition of the quality control unit accepting or rejecting the material . </li></ul>
  21. 21. REFERENCE <ul><li>Good Manufacturing Practice, Quality Control Guidelines, Basic Standard In the Manufacture Of Drugs Pharmaceuticals Companion Volume to Handbooks Of Drug Laws - By M.L. Mehra. </li></ul><ul><li>How to practice GMPs P.P.Sharma. </li></ul><ul><li>Pharmaceutical Production And Management, CVS subrahmanyam. </li></ul>
  22. 22. <ul><li>THANK </li></ul><ul><li>YOU </li></ul>