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Documentation in pharmaceutical industry

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it includes details information about specifications, test procedures, protocols , reports and distribution records.

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Documentation in pharmaceutical industry

  1. 1. Documentation In Pharmaceutical Industry Name : Gayatri H. Tiwaskar M.Pharm 1st year (QA) Guided by : Mrs. Monali N. Dumore Dadasaheb Balpande College Of Pharmacy , Nagpur. 1
  2. 2. Index Introduction Specification Test procedures Protocols and reports Distribution records 2
  3. 3. What is Documentation ?  Document is a written report or record that provides information  Documentation is a method of preparing a written material, which describes the process in terms of specifications ,instructions etc.  Document is a piece of written, printed or electronic matter that provides information or evidence.  A Good Documentation is essential part of QA system . 3
  4. 4. Importance of Documentation  It provides the working details necessary for manufacturing, packaging, quality control.  Reduce the risk of mistakes inherent in verbal communication.  They help in decreasing the batch to batch variation so that quality of product is kept with in the limit of acceptability.  Documentation and records are essentials for obtaining ACCREDIATION ,certification of ISO, and approval by Federal bodies. 4
  5. 5. Why Documentation? There is a saying in the pharmaceutical industry: 'if it hasn't been documented, then it hasn't happened!' “YOUR DOCUMENTATION IS AN ADVERTISEMENT FOR YOUR WORK . 5
  6. 6. Specification  It is define as a set of parameters expected to be met by a particular materials, peace of equipments or any such object.  Every specification is a company's unique document and it must have certain common contents and thereafter each type of document should have some specific contents. 6
  7. 7. In case of pharmaceutical products we need specifications for  Active and inactive starting materials  Primary ,printed and other packaging materials  Intermediate and bulk products  Finished pharmaceutical products 7
  8. 8. A document specification contains several parts:  a description of the audience(s) for the document.  a detailed outline giving the structure and contents of the document.  a work plan showing who is responsible for each part of the document.  what the deadlines are for completing each task. 8
  9. 9. Three purposes for document specifications: In the workplace, formal document specifications serve three important functions:  economy of effort,  work planning,  writing organization. 9
  10. 10. Common Contents 1.Name of the company and its address or location. 2.Title of the document viz. “specification” 3.Date of issue and implementation, effective date, date of preparation, checking and authorisation, proposed date of review. 4.Names and signature of persons preparing, checking, and authorising the specification. 5.Unique identification number 6.Pharmacopoieal or other references 7.Circulation list 10
  11. 11.  Specific Contents 1. Specification for active and inactive starting materials. 2. Specification for packaging materials. 3. Specification for intermediate and bulk products. 4. Specification for finished products. 11
  12. 12.  Active and inactive starting materials 1.Name of material. 2.Code number references. 3.Pharmacopoial reference to the specific monograph. 4.Qualitative and quantitative requirements, Physical and chemical characterisation, microbiological standards and assay etc. Acceptance limits, covering tests and limits for identity, purity. 5.Name of approved suppliers and original manufacturer. 12
  13. 13. 6.Direction for sampling and testing or reference to the procedures. 7.Storage conditions and safety precautions. 8.The maximum period of storage before re- examination. 9.Details of or ref. to test method to be used to assess compliance with the specification. 13
  14. 14. Packaging material 1.Name of material. 2.Code number reference. 3.Description of nature, dimensions, and materials of construction of the components with quality standards, control limits, mould reference, drawing and details of the test. 4.List of approved supplies/manufacturers. 5.Sampling instructions. 6.storage conditions. 14
  15. 15. 7.Frequency of re-examination of stored components. 8.Details of reference to the test methods to be used to asses compliance with the specification. 9.A file of reference specimens of current printed packaging materials should be maintained.  this should include a colour comparison standard also.  each specimens in this must be certified by the QC personnel. 15
  16. 16. Intermediate and bulk product The following things should be added to the common contents.  It should be available if these are purchased or dispatched  or if data obtained from intermediate products are used in the evaluation of the finished products.  These specifications should be similar to starting material or finished products . 16
  17. 17. Finished Products 1.Name of the product 2.Code number reference 3.Names of the ingredients 4.The formula or reference to the formula 5.A description of dosage forms and package details. 6.Direction for sampling and testing or reference to procedures. 17
  18. 18. 7.The qualitative and quantitative requirements with acceptance limits. 8.The storage conditions and precautions, if applicable. 9.Shelf life. 18
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  23. 23. Test Procedures  Universal tests/Criteria • New drug substance 1 • New drug product 2 23
  24. 24. New Drug Substance The following tests and acceptance criteria are considered generally applicable to new drug substances.  Description : a qualitative statement about the state (e.g. Solid, liquid) and color of the new drug substance. If any of these characteristics change during storage ,this change should be investigated and appropriate action taken. 24
  25. 25.  Identification : identification testing should optimally be able to discriminate between compounds of closely related structure which are likely to be present. Identification tests should be specific for the new drug substance, e.g., infrared spectroscopy. 25
  26. 26.  Assay : A specific, stability indicating procedure should be included to determine the content of new drug substance. In many cases it is possible to employ the same procedure (e. g., HPLC) for both assay of the new drug substance and quantitation of impurities. 26
  27. 27.  Impurities : Organic and inorganic impurities and residual solvents are included in this category. (Refer to the ICH Guidelines Impurities in new drug substances and Residual solvents in pharmaceuticals for detailed information.)  as per the ICH guideline Q3 A 27
  28. 28. Classification of impurities • Organic • Inorganic • Residual solvents 28
  29. 29. Organic impurities This may arise during the manufacturing process or during the storage, they may be identified or unidentified and volatile or non-volatile, it includes, starting material by-product intermediates degradation product ligands, catalyst and reagents 29
  30. 30. Inorganic impurities They may arise in manufacturing process, they may be known and identified. It includes, Reagent, ligands and catalyst Heavy metals Inorganic solvents Other materials ( e.g. charcoal ) 30
  31. 31. Residual solvents This are the organic and inorganic solvents which is used during the manufacturing, it may be easily not removed by manufacturing process. This are generally of known toxicity. 31
  32. 32. Limits  Each identified specified impurity.  Each identified unspecified impurity at or above 0.1%.  Any unspecified impurity, with a limit of not more than 0.1%.  Total impurities. 32
  33. 33. New Drug Product  Description : A qualitative description of the dosage form should be provided ( e.g., size, shape and color).  Identification  Assay  Impurities 33
  34. 34.  Specific tests/ Criteria when the tests have an impact on the quality of drug substance and drug product. Tests other than this may be needed in particular situations or as new information become available. 34
  35. 35. Test 1. Physicochemic- al properties pH of aqueous solution, melting point and refractive index. 2. Particle size For some new drug substance intended for use in solid or suspension drug product, particle size have a significant effect on dissolution rates, bioavailability, and/ or stability. 3.Polymeric form Some new drug substances exist in different crystalline form which differ in their physical properties. 4.Water content This test is important in cases where the new drug substance is known to be hygroscopic or degraded by moisture 35
  36. 36. Test 5.Inorganic impurities Development and based on knowledge of the manufacturing process. 6.Microbial limits There may be a need to specify the total count of aerobic microorganisms. 36
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  38. 38. Protocol  Protocols are written records clearly defining the objectives and methods that will be used for the validation programs.  An important part of the protocol is the description of the testing method including who will test the system, how they will test it and what data is to be collected and reported. 38
  39. 39.  Computerized system protocols often include the three distinct stages as described in PMA reports: Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ). 39
  40. 40. Installation Qualification 40
  41. 41. Operational Qualification 41
  42. 42. Performance Qualification 42
  43. 43. Protocol Changes Document requirements specifies that who and how changes can be done to parameters, thresholds, and acceptance criteria. It is not impossible to make changes after or during testing, but these changes must be properly implemented and approved to be validated. 43
  44. 44. Protocol for Documentations 1.Serial number of the Batch Manufacturing Record. 2.Name of the product. 3.Reference to Master Formula Record. 4.Batch/Lot number. 5.Batch/Lot size. 6.Date of commencement of manufacture and date of completion of manufacture. 44
  45. 45. 7.Date of manufacture and assigned date of expiry. 8.Date of each step in manufacturing. 9.Names of all ingredients with the grade given by the quality control department. 10.Quality of all ingredients. 11. Control reference numbers for all ingredients. 12. Time and duration of blending, mixing, etc. whenever applicable. 13. pH of solution whenever applicable. 45
  46. 46. 14. Filter integrity testing records. 15. Temperature and humidity records whenever applicable. 16. Records of plate-counts whenever applicable. 17. Results of pyrogen and/or bacterial endotoxin & toxicity. 18. Results of weight or volume of drug filled in containers. 19. Bulk sterility in case of aseptically filled products. 20. Leak test records. 46
  47. 47. 21. Inspection records. 22. Sterilization records including autoclave leakage test records, load details, date, duration, temperature, pressure, etc. 23. Container washing records. 24. Total number of containers filled. 25.Total numbers of containers rejected at each stage. 26. Theoretical yield, permissible yield, actual yield and variation thereof. 27. Clarification for variation in yield beyond permissible yield. 47
  48. 48. 28. Reference numbers of relevant analytical reports. 29. Details of reprocessing, if any. 30. Name of all operators carrying out different activities. 31.Environmental monitoring records. 32. Specimens of printed packaging materials. 33. Records of destruction of rejected containers printed packaging and testing. 34. Signature of competent technical staff responsible for manufacture and testing. 48
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  50. 50. Report Documentation and records used throughout the manufacturing process, as well as supporting processes ( e. g. Quality Control or Quality Assurance) It includes,  Batch Record Forms  Bill of materials ( BOM)  Specifications 50
  51. 51. Policies Protocols Standard Operation Procedure (SOPs) Work Instructions (WIs) Check lists Forms/ long sheets Certificates of Analyses or Certificates of Compliance Technical transfer reports Test Methods Training Assessments 51
  52. 52. Records Worksheet, notebooks and long books Manufacturing and packaging instructions Confidentiality agreements Change control Quality system related documents Quality manual Validation protocols and reports Deviation reports Audit plans Electronic and hard-copy Quality records 52
  53. 53. Test material related documents including product specification, test material receipt and reports. Personal related documents including training records. Facility related documents including floor plans, environmental specifications. Deviation forms including unplanned deviations and system failure investigation. 53
  54. 54. Distribution Records It contain name and strength of the product and description of the dosage form, name and address of the consignee, date quantity shipped, and lot or control number of the drug product. Distribution records include a wide range of documentation such as invoices, bill of lading customer receipts, and internal warehouse storage and inventory records. 54
  55. 55. The information required need not be on every document. Also customer codes and product codes may be used as alternates to customers name and addresses and product names. Records for distribution shall be maintained in a manner such that finished batch of a drug can be traced to the retain level to facilitate prompt and complete recall of the batch, if and when necessary. 55
  56. 56. Document Required  SOP on distribution of finished products for sale or sample.  Records of distribution. 56
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  59. 59. Thank You ! 59