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GxP and cGxP in Bio/Pharmaceutical Industry

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Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi, GxP and cGxP in Bio/Pharmaceutical Industry

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GxP and cGxP in Bio/Pharmaceutical Industry

  1. 1. GxP and cGxP in Bio/Pharmaceutical Industry Prof. Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D Department of Pharmaceutics KLE University College of Pharmacy BELGAUM – 590010, Karnataka, India E-mail: bknanjwade@yahoo.co.in Cell No: 00919742431000 28 March 2011 1Department of Pharmaceutics
  2. 2. GxP • The bio/pharmaceutical industry has created its own language and GxP is one of many acronyms that we all tend to use. • While this may seem “elementary” to some of you, many people may not know what this means. • G = Good x (variable replaced with Manufacturing, Clinical, Laboratory, Storage, Distribution and Review) P = Practice 2Department of Pharmaceutics28 March 2011
  3. 3. GxP • As you can see, GxP is used as short-hand form for referring to the regulations established by the United States Food and Drug Administration which are published in the Code of Federal Regulations. • Sometimes people refer to the “GCPs” which specifically regards the rules that govern clinical trials vs. product manufacturing (GMPs) or laboratory regulations (GLPs). • Together, these are known collectively as the “predicate rules” that govern a wide spectrum of regulatory obligations across this diverse industry. 3Department of Pharmaceutics28 March 2011
  4. 4. GxP • GxP is also where citations emanate from (typically) as regards FDA inspections. • When a regulation is cited, the title tells you where it is published. For example: 21 CFR 312.2 Means: 21 = Title 21 CFR = Code of Federal Regulations 312.2 (312 = part and 2 =section) 4Department of Pharmaceutics28 March 2011
  5. 5. Lifecycle Requirements 5Department of Pharmaceutics28 March 2011
  6. 6. GxP • “GxP” is a collective term for the Good Practice quality guidelines and regulations used in many fields, encompassing such internationally-recognized standards as GMP, GCP, GLP, GSP, GDP and GRP. • GxP guidelines are designed to ensure that products are safe, meet their intended use and, in regulated industries such as drugs, food, medical devices and cosmetics, adhere to quality processes during manufacturing, control, storage and distribution. 6Department of Pharmaceutics28 March 2011
  7. 7. GxP • GxP is a general term for Good Practice quality guidelines and regulations. These guidelines are used in many fields, including the pharmaceutical and food industries. • The titles of these good practice guidelines usually begin with "Good" and end in "Practice", with the specific practice descriptor in between. • GxP represents the abbreviations of these titles, where x (a common symbol for a variable) represents the specific descriptor. 7Department of Pharmaceutics28 March 2011
  8. 8. Core GXP Information 8Department of Pharmaceutics28 March 2011
  9. 9. Regional Harmonization Initiatives 9Department of Pharmaceutics28 March 2011
  10. 10. GxP 10Department of Pharmaceutics28 March 2011
  11. 11. List of GxP’s in Pharmaceuticals 1. GMP – (Good manufacturing Practice) 2. GCP – (Good Clinical Practice) 3. GLP – (Good Laboratory Practice) 4. GSP – (Good Storage Practice) 5. GDP – (Good Distribution practice) 6. GRP – (Good Review Practice) 11Department of Pharmaceutics28 March 2011
  12. 12. Purpose of GxP • The purpose of the GxP quality guidelines is to ensure a product is safe and meets its intended use. • GxP guides quality manufacture in regulated industries including food, drugs, medical devices and cosmetics. The most central aspects of GxP are: 1. Traceability: the ability to reconstruct the development history of a drug or medical device. 2. Accountability: the ability to resolve who has contributed what to the development and when. 12Department of Pharmaceutics28 March 2011
  13. 13. Regulators 13Department of Pharmaceutics28 March 2011
  14. 14. GMP – (Good Manufacturing Practice) 28 March 2011 Department of Pharmaceutics 14
  15. 15. What is GMP ? • GMP is that part of Quality assurance which ensures that the products are consistently manufactured and controlled to the Quality standards appropriate to their intended use • A set of principles and procedures which, when followed by manufacturers for therapeutic goods, helps ensure that the products manufacture will have the required quality. 28 March 2011 Department of Pharmaceutics 15
  16. 16. Good Manufacturing Practices • A basic tenet of GMP is that quality cannot be tested into a batch of product but must be built into each batch of product during all stages of the manufacturing process. • It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. - Some of the main risks are unexpected contamination of products, causing damage to health or even death - In correct labels on containers, which could mean that patient receive the wrong medicine. - Insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. 28 March 2011 Department of Pharmaceutics 16
  17. 17. GMP 28 March 2011 Department of Pharmaceutics 17 QC GMP QA
  18. 18. GMP • GMP is the magic key that opens the door of the Quality • In matter of GMP, swim with the current and in matter of Quality stand like a rock! 28 March 2011 Department of Pharmaceutics 18
  19. 19. GMP 28 March 2011 Department of Pharmaceutics 19 GMP Is that part of Quality Assurance aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use
  20. 20. GMP guidelines • GMP as per Schedule “M” • GMP as per WHO • GMP as per MCA now known as MHRA • GMP as per TGA • GMP as per US FDA • GMP as per ICH guidelines 28 March 2011 Department of Pharmaceutics 20
  21. 21. GMP guidance documents • EU Good Manufacturing Practice (GMP) Guidelines, Volume 4 of “The rules governing medicinal products in the European Union” • US FDA current Good Manufacturing Practice (cGMP) for finished pharmaceuticals, 21 CFR, 210 and 211 • WHO Good Manufacturing Practices for pharmaceutical products, Annex 4 to WHO Technical Report Series, No. 908, 2003 21Department of Pharmaceutics28 March 2011
  22. 22. GMP • GMP in solid dosage forms • GMP in semisolid dosage forms • GMP in Liquid orals • GMP in Parenterals Production • GMP in Ayurvedic medicines • GMP in Bio technological products • GMP in Nutraceuticals and cosmeceuticals 28 March 2011 Department of Pharmaceutics 22
  23. 23. API Manufacturing Process 23Department of Pharmaceutics28 March 2011
  24. 24. Secondary Manufacturing Dosage Forms 24Department of Pharmaceutics28 March 2011
  25. 25. Secondary Manufacturing Process - Tablets 25Department of Pharmaceutics28 March 2011
  26. 26. Secondary Manufacturing Process – Sterile parenteral for injection 26Department of Pharmaceutics28 March 2011
  27. 27. Packaging 27Department of Pharmaceutics28 March 2011
  28. 28. Packaging 28Department of Pharmaceutics28 March 2011
  29. 29. Packaging 29Department of Pharmaceutics28 March 2011
  30. 30. Biotechnology Manufacturing Process 30Department of Pharmaceutics28 March 2011
  31. 31. Ten Principles of GMP 1. Design and construct the facilities and equipments properly 2. Follow written procedures and Instructions 3. Document work 4. Validate work 5. Monitor facilities and equipment 6. Write step by step operating procedures and work on instructions 7. Design ,develop and demonstrate job competence 8. Protect against contamination 9. Control components and product related processes 10. Conduct planned and periodic audits 28 March 2011 Department of Pharmaceutics 31
  32. 32. Beyond GMP • Reduce pollution - Zero discharge • Adaptation of environment friendly methods • Consideration for better and healthier life tomorrow • Consideration of ethics in life • One should begin with end in mind otherwise it will be the beginning of the end 28 March 2011 Department of Pharmaceutics 32
  33. 33. Cost of effective GMP • In fact Cost benefits – positive cost benefits of GMP/QA • Good plant lay out, Smooth work flows, Efficient documentation systems, well controlled process, good stores lay outs and stores records- These are Good manufacturing practices • Reduction in work in process and inventory holding costs • Avoidance of cost of Quality failure ( cost of waste, of rework, of recall, of consumer compensation and of loss of company reputation28 March 2011 Department of Pharmaceutics 33
  34. 34. Cost / Benefit analysis • GMP is not an “On-cost”. • It is not even “Just free” • It is a contribution to profit • Good manufacturing Practice is also Good management Practice leading to Good Manufacturing Profit • GMP is central and basic and has cost benefits ( not to be considered as extrinsic or imposed upon manufacturing activities) 28 March 2011 Department of Pharmaceutics 34
  35. 35. Cost / benefit analysis 28 March 2011 Department of Pharmaceutics 35 • Cost of quality = Cost of A – Cost of B- Payback from C = Profit A B C Staff Scrap Improved morale Training Rework Motivation Systems Complaints Faster throughput Documentation Chaos Higher productivity Equipment Lost sales Increased sales Maintenance Recalls lower inventory Calibration Closedown Sampling Testing In process control Validation Auditing
  36. 36. GCP – (Good Clinical Practice) 28 March 2011 Department of Pharmaceutics 36
  37. 37. What It Is GCP • An international ethical & scientific quality standard for designing, conducting, recording & reporting human clinical studies – EU – Japan – US • Applies to registration studies that may have an impact on safety & welfare of human subjects 28 March 2011 Department of Pharmaceutics 37
  38. 38. GCP Participating Parties • IRB/Ethics Committee • Investigators • Sponsor • Regulatory Authorities 28 March 2011 Department of Pharmaceutics 38
  39. 39. GCP Key Documents • Investigator Brochure • Study Protocol • Informed Consent Document 28 March 2011 Department of Pharmaceutics 39
  40. 40. GCP Principles 1. Studies in accordance with Declaration of Helsinki; consistent with GCP & applicable regulatory requirements 2. Studies initiated & continued only if anticipated benefits outweigh risks 3. Rights, safety & welfare of human subjects take priority over interests of science & society 4. Available non-clinical & clinical info on product adequate to support study 28 March 2011 Department of Pharmaceutics 40
  41. 41. GCP Principles 5. Studies scientifically sound; described in clear, detailed protocol 6. Study in compliance with IRB/EC approved protocol 7. Medical care given to subjects is the responsibility of qualified medical professional(s) 8. Individuals conducting studies qualified by education, training & experience 9. Freely given informed consent obtained from every subject prior to study participation 28 March 2011 Department of Pharmaceutics 41
  42. 42. GCP Principles 10. Study information recorded, handled & stored to allow accurate reporting, interpretation & verification 11. Confidentiality of subject records protected in accordance with applicable regulatory requirements 12. Investigational products manufactured, handled & stored in accordance with GCP & used in accordance with approved protocol 13. Systems/procedures implemented to assure quality of study 28 March 2011 Department of Pharmaceutics 42
  43. 43. IRB/EC Roles & Responsibilities To safeguard study subjects’ rights & welfare by: • Evaluation/disposition of study proposal • Evaluation of proposed subject consent materials • Evaluation of emergency use consent methodology • Evaluation of investigator qualifications • Ongoing review of study progress (at least yearly) • Evaluation of proposed subject compensation plans 28 March 2011 Department of Pharmaceutics 43
  44. 44. IRB/EC Composition & Operations • Membership has qualifications & experience to evaluate science, medical aspects & ethics of proposed study – ≥ 5 members – ≥ 1 member whose primary interest in nonscientific – ≥ 1 member independent of institution or study site • Written SOPs & records • Decisions rendered at announced meetings with quorum in attendance 28 March 2011 Department of Pharmaceutics 44
  45. 45. IRB/EC Composition & Operations • Only members participating in review should vote • Investigator may provide info on study, but should not be involved in review or vote • Nonmembers with expertise in special areas may be invited to assist with review (but cannot vote) 28 March 2011 Department of Pharmaceutics 45
  46. 46. IRB/EC Procedures • Document group membership & qualifications • Schedule meetings & notify members • Conduct initial & ongoing review of studies • Determine ongoing review frequency • Provide expedited review of minor study changes, in accordance with regulatory requirements • Specify that no subject should be enrolled in study prior to IRB/EC approval 28 March 2011 Department of Pharmaceutics 46
  47. 47. IRB/EC Procedures • Specify that no deviations from protocol should be initiated without prior IRB/EC approval – Emergency situations require immediate notification of IRB/EC after the fact • Specify that Investigator should promptly report: – Protocol deviations – Changes increasing subject risk or study procedures – Serious and unexpected adverse events 28 March 2011 Department of Pharmaceutics 47
  48. 48. IRB/EC Procedures • Notify Investigator promptly of: – Study-related decisions – Reason for decisions – Procedures for appeal of decisions 28 March 2011 Department of Pharmaceutics 48
  49. 49. IRB/EC Required Records • Relevant records maintained ≥ 3 yr after study completion • Records available for review by regulatory authorities 28 March 2011 Department of Pharmaceutics 49
  50. 50. IRB/EC What is Reviewed • Investigator Brochure or Report of Prior Investigations • Study protocol & amendments • Investigator qualifications • Informed consent documents, including subject recruiting tools • Other written information provided to subjects • Subject compensation plans • Adverse events • Protocol deviations 28 March 2011 Department of Pharmaceutics 50
  51. 51. IRB/EC When Reviews Occur • Prior to study initiation at site • At least yearly during study • During study, as necessitated by: – Changes in protocol, consent documents, etc. – Changes in study investigator – Reports of serious or unanticipated device-related adverse events • At study completion or termination 28 March 2011 Department of Pharmaceutics 51
  52. 52. Investigator Roles & Responsibilities • Qualified to conduct study • Have adequate resources to conduct study • Provide medical care to study subjects • Regular communication with IRB/EC reviewing study • Compliance with study protocol • Maintenance of investigational product accountability • Compliance with study randomization & unmasking procedures • Provide informed consent to study subjects 28 March 2011 Department of Pharmaceutics 52
  53. 53. Investigator Responsibilities Appropriate Qualifications • Training & experience demonstrated via: – Medical license – CV – Specialized study training – GCP training • If study responsibilities delegated, need a list of qualified persons to whom responsibilities are delegated 28 March 2011 Department of Pharmaceutics 53
  54. 54. Investigator Responsibilities Adequate Resources • Suitable staff & good methods for keeping them apprised • Suitable facilities • Appropriate patient population – Access to disease or condition – Volume of patients with disease or condition 28 March 2011 Department of Pharmaceutics 54
  55. 55. Investigator Responsibilities Required Records & Reports • Essential regulatory document file(s) – Protocol & amendments – Approved informed consent documents – Product accountability documentation – Investigator qualifications & agreements – IRB correspondence – Study delegation list – Subject screening/enrollment logs – Study monitoring reports – Calibration/maintenance logs – Memos to file 28 March 2011 Department of Pharmaceutics 55
  56. 56. Sponsor Roles & Responsibilities • Study quality assurance • Appropriately qualified medical personnel to advise on study • Utilization of qualified personnel in study design & operations • Study management, data handling & record keeping • Investigator selection & training • Definition/allocation of study responsibilities 28 March 2011 Department of Pharmaceutics 56
  57. 57. Sponsor Roles & Responsibilities • Facilitation of communications between Investigators • Study compensation (investigators and/or subjects) & financing • Regulatory authority notification/submission • Confirmation of IRB/EC review/approval • Investigational product information • Investigational product manufacturing, packaging, labeling & coding • Investigational product supply & handling28 March 2011 Department of Pharmaceutics 57
  58. 58. Sponsor Roles & Responsibilities • Record access • Ongoing safety evaluation & reporting • Serious/unanticipated adverse event reporting • Study monitoring • Study noncompliance procedures • Study termination or suspension notification • Study reports 28 March 2011 Department of Pharmaceutics 58
  59. 59. Sponsor Roles & Responsibilities • Sponsor may transfer responsibilities to CRO – Transfer must be documented in writing – Sponsor still has ultimate responsibility for study quality and data integrity 28 March 2011 Department of Pharmaceutics 59
  60. 60. Study Protocol Components • General administrative info • Background • Study purpose & objectives • Study design • Subject eligibility requirements • How subjects will be treated • How safety & efficacy will be assessed • Sample size justification & statistical analysis methods 28 March 2011 Department of Pharmaceutics 60
  61. 61. Study Protocol Components • How data will be captured & maintained • Monitoring procedures • Proposed informed consent document 28 March 2011 Department of Pharmaceutics 61
  62. 62. Informed Consent Document Components • Statement that study involves “research” & product “experimental” (if applicable) • Study purpose • Number of expected study subjects to be enrolled • Study treatment(s) & probability for random assignment • Study exams & procedures for duration of trial • Subject’s responsibilities • Foreseeable risks to subject (embryo, fetus, nursing infant) 28 March 2011 Department of Pharmaceutics 62
  63. 63. Informed Consent Document Components • Expected benefits • Alternatives procedures or therapies & associated risk/benefit • Compensation available in event of study-related injury or sickness • Anticipated payments to subject for study participation • Anticipated expenses to subject for study participation • Statement that participation is voluntary 28 March 2011 Department of Pharmaceutics 63
  64. 64. Informed Consent Document Components • Description of extent to which confidentiality can be assured • Commitment to keep subject apprised on new information that may affect subject’s willingness to participate in study • Contact info for questions re: subject rights; trial- related adverse events • Circumstances under which subject’s participation may be terminated 28 March 2011 Department of Pharmaceutics 64
  65. 65. Investigator Brochure What It Is A compilation of clinical & non-clinical data on the product that is relevant to the product’s study in humans Necessary for Investigator & IRB/EC review to assess the risks/benefits associated with study 28 March 2011 Department of Pharmaceutics 65
  66. 66. Investigator Brochure Components Product formulation summary Introduction/background info regarding product & investigational plan • Investigational product physical, chemical & pharmaceutical properties & formulation • Non-clinical studies • Human clinical studies • Summary of data & guidance for Investigator 28 March 2011 Department of Pharmaceutics 66
  67. 67. Good Clinical Practice Reference Documents & Links • ICH - E6: Guideline for Good Clinical Practice • 21 CFR 50 - Informed Consent • 21 CFR 56 - Institutional Review Board • http://www.ich.org/cache/compo/276-254-1.html • http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/c 28 March 2011 Department of Pharmaceutics 67
  68. 68. GLP – (Good Laboratory Practice) 28 March 2011 Department of Pharmaceutics 68
  69. 69. What It Is GLP • Describes good practices for non-clinical lab studies that support research or marketing approvals for FDA-regulated products 28 March 2011 Department of Pharmaceutics 69
  70. 70. GLP General Requirements • Appropriately qualified personnel • Adequate resources • Appropriate procedures for: – Sanitation, health precautions, clothing – Test protocol development, test methods – Data analysis, report development • Appropriately qualified study director • Quality assurance function 28 March 2011 Department of Pharmaceutics 70
  71. 71. GLP Facilities Requirements • Suitable size, construction, segregation – Animal care – Animal supplies – Test & control products maintained in a secure area – Operating “suite” – Specimen & data storage 28 March 2011 Department of Pharmaceutics 71
  72. 72. GLP Equipment Requirements • Appropriately designed • Adequate thru-put capacity • Appropriately located • Routinely maintained & calibrated 28 March 2011 Department of Pharmaceutics 72
  73. 73. GLP Standard Operating Procedures • Animal room prep • Animal care • Receipt, ID, storage, handling, mixing & sampling of test & control articles • Test system observations • Lab tests • Handling of moribund or dead animals • Necropsy or postmortem exams of animals 28 March 2011 Department of Pharmaceutics 73
  74. 74. GLP Standard Operating Procedures • Collection & ID of specimens • Histopathology • Data handling, storage & retrieval • Equipment maintenance & calibration • Transfer, proper placement & ID of animals 28 March 2011 Department of Pharmaceutics 74
  75. 75. GLP Reagents & Solutions • Adequate labeling – Identity – Concentration – Storage requirements – Expiration date 28 March 2011 Department of Pharmaceutics 75
  76. 76. GLP Test & Control Articles • Adequate characterization • Proper receipt, storage, distribution • When mixed with a carrier, adequate methods to confirm – Mixture uniformity – Article concentration – Article stability 28 March 2011 Department of Pharmaceutics 76
  77. 77. GLP Study Implementation • Written, approved protocol indicating test objectives & methods • Study conducted in accordance with protocol • Study monitoring to confirm protocol compliance • Appropriate labeling of specimens by test system, study, nature & collection date • Records of gross findings from postmortems available to pathologist for specimen histopathology 28 March 2011 Department of Pharmaceutics 77
  78. 78. GLP Study Implementation • Standard data capture/recording requirements – Legibility – Permanence – Accountability – Changes 28 March 2011 Department of Pharmaceutics 78
  79. 79. GLP Records & Reports • Final report of results • Study records & data methodically archived to facilitate expedient retrieval – Study documents – Raw data – Specimens – Protocols – QA inspections – Personnel training & qualifications – Calibration & maintenance records 28 March 2011 Department of Pharmaceutics 79
  80. 80. GLP Records & Reports • Records retention (shortest of): – ≥ 2 yr after FDA marketing clearance – ≥ 5 yr after data submitted to FDA in support of marketing application – ≥ 2 yr after Sponsor decision not to proceed with marketing application – Wet specimens hold as long as viable • Records transferable with written FDA notification 28 March 2011 Department of Pharmaceutics 80
  81. 81. GLP Facility Disqualification • Grounds for disqualification: – Failure to comply with regulations & – Noncompliance adversely affects study validity & – Previous regulatory actions have been unsuccessful in modifying facility operations 28 March 2011 Department of Pharmaceutics 81
  82. 82. GSP – (Good Storage Practice) 28 March 2011 Department of Pharmaceutics 82
  83. 83. GSP – (Good Storage Practice) 1. Glossary 2. Personnel 3. Premises and facilities 4. Storage requirements 5. Returned goods 6. Dispatch and transport 7. Product recall 83Department of Pharmaceutics28 March 2011
  84. 84. 1. Glossary a. Active pharmaceutical ingredient b. Contamination c. Cross-contamination d. Excipient e. Expiry date f. Labelling 28 March 2011 Department of Pharmaceutics 84
  85. 85. 1. Glossary g. Packaging material h. Pharmaceutical product i. Production j. Retest date k. Storage l. Supplier 28 March 2011 Department of Pharmaceutics 85
  86. 86. 2. Personnel • At each storage site (e.g. that of a manufacturer, distributor, wholesaler, community or hospital pharmacy) there should be an adequate number of qualified personnel to achieve pharmaceutical quality assurance objectives. • National regulations on qualifications should be followed. 28 March 2011 Department of Pharmaceutics 86
  87. 87. 2. Personnel • All personnel should receive proper training in relation to good storage practice, regulations, procedures and safety. • All members of staff should be trained in, and observe high levels of, personal hygiene and sanitation. • Personnel employed in storage areas should wear suitable protective or working garments appropriate for the activities they perform 28 March 2011 Department of Pharmaceutics 87
  88. 88. 3. Premises and facilities a. Storage areas b. Storage conditions c. Monitoring of storage conditions 28 March 2011 Department of Pharmaceutics 88
  89. 89. 4. Storage requirements a. Documentation: written instructions and records b. Labeling and containers c. Receipt of incoming materials and pharmaceutical products d. Stock rotation and control 28 March 2011 Department of Pharmaceutics 89
  90. 90. 5. Returned goods • Returned goods, including recalled goods, should be handled in accordance with approved procedures and records should be maintained. • All returned goods should be placed in quarantine and returned to saleable stock only after this has been approved by a nominated, responsible person following a satisfactory quality re-evaluation. • Any stock reissued should be so identified and recorded in stock records. Pharmaceuticals returned from patients to the pharmacy should not be taken back as stock, but should be destroyed. 28 March 2011 Department of Pharmaceutics 90
  91. 91. 6. Dispatch and transport • Records for dispatch should be retained, stating at least: — the date of dispatch; — the customer’s name and address; — the product description, e.g. name, dosage form and strength (if appropriate), batch number and quantify; — the transport and storage conditions. • All records should be readily accessible and available on request. 28 March 2011 Department of Pharmaceutics 91
  92. 92. 7. Product recall • There should be a procedure to recall from the market, promptly and effectively, pharmaceutical products and materials known or suspected to be defective. 28 March 2011 Department of Pharmaceutics 92
  93. 93. GDP – (Good Distribution practice) 28 March 2011 Department of Pharmaceutics 93
  94. 94. GDP – (Good Distribution practice) • GDP governs the proper distribution of medicinal products for human use and regulates the movement of products from the manufacturers’ premises (or other central point) to the end user (or other intermediate point). 94Department of Pharmaceutics28 March 2011
  95. 95. GDP – (Good Distribution practice) 1. Principle 2. Personnel 3. Documentation 4. Premises and equipment 5. Deliveries to customers 6. Returns 7. Self inspection 8. Provision of information to Member States in relation to wholesale activities 28 March 2011 Department of Pharmaceutics 95
  96. 96. 1. Principle • Policy ensures that products released for distribution are of the appropriate quality. • In addition to this, the quality system should ensure that the right products are delivered to the right addressee within a satisfactory time period. • A tracing system should enable any faulty product to be found and there should be an effective recall procedure. 28 March 2011 Department of Pharmaceutics 96
  97. 97. 2. Personnel • He should fulfil his responsibilities personally. • Person should be appropriately qualified: although a degree in Pharmacy is desirable, the qualification requirements may be established by the Member State on whose territory the wholesaler is located. 28 March 2011 Department of Pharmaceutics 97
  98. 98. 2. Personnel • Key personnel involved in the warehousing of medicinal products should have the appropriate ability and experience to guarantee that the products or materials are properly stored and handled. • Personnel should be trained in relation to the duties assigned to them and the training sessions recorded. 28 March 2011 Department of Pharmaceutics 98
  99. 99. 3. Documentation • All documentation should be made available on request of competent authorities a. Orders b. Procedures c. Records 28 March 2011 Department of Pharmaceutics 99
  100. 100. 4. Premises and equipment • Premises and equipment should be suitable and adequate to ensure proper conservation and distribution of medicinal products. a. Receipt b. Storage 28 March 2011 Department of Pharmaceutics 100
  101. 101. 5. Deliveries to customers • Deliveries should be made only to other authorised wholesalers or to persons authorised to supply medicinal products to the public in the Member State concerned. • In case of emergency, wholesalers should be in a position to supply immediately the medicinal products that they regularly supply to the persons entitled to supply the products to the public. 28 March 2011 Department of Pharmaceutics 101
  102. 102. 5. Deliveries to customers • Medicinal products should be transported in such a way that : a) Their identification is not lost; b) They do not contaminate, and are not contaminated by, other products or materials; c) Adequate precautions are taken against spillage, breakage or theft; d) They are secure and not subjected to unacceptable degrees of heat, cold, light, moisture or other adverse influence, nor to attack by microorganisms or pests. 28 March 2011 Department of Pharmaceutics 102
  103. 103. 6. Returns a. Returns of non-defective medicinal products b. Emergency plan and recalls c. Counterfeit medicinal products d. Special provisions concerning products classified as not for sale 28 March 2011 Department of Pharmaceutics 103
  104. 104. 7. Self inspection • Self-inspections should be conducted 9and recorded) in order to monitor the implementation of and compliance with this guideline. 28 March 2011 Department of Pharmaceutics 104
  105. 105. 8. Provision of information to Member States in relation to wholesale activities • Wholesalers wishing to distribute or distributing medicinal products in Member State(s). • Where appropriate, the competent authorities of this (these) other Member State(s) will inform the wholesaler of any public service obligation imposed on wholesalers operating on their territory. 28 March 2011 Department of Pharmaceutics 105
  106. 106. Guidance documents deal with GDP • WHO Good Distribution Practice, Annex 5 to Technical Report Series, No. 937, 2006 • Health Canada Guidelines for Temperature Control of Drug Products during Storage and Transportation, 2005 • Irish Medicines Board Guide to Control and Monitoring of Storage and Transportation Temperature Conditions for Medicinal Products and Active Substances, 2006 • USP chapter <1079> Good Storage and Shipping Practice • EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03) 106Department of Pharmaceutics28 March 2011
  107. 107. GRP – (Good Review Practice) 28 March 2011 Department of Pharmaceutics 107
  108. 108. GRP – (Good Review Practice) • A good review practice (GRP) is a documented best practice within CDER that discusses any aspect related to the process, format, content, and/or management of a product review. • GRPs are developed over time as superior practices based on CDER’s collective experience to provide consistency to the overall review process of new products. • GRPs are developed to improve the quality of reviews and review management. 28 March 2011 Department of Pharmaceutics 108
  109. 109. GRP – (Good Review Practice) • GRPs improve efficiency, clarity, and transparency of the review process and review management. • GRPs are expected to be adopted by review staff as standard processes through supervisor mentoring, implementation teams, and formal training when necessary. • Developing GRPs is an attempt to identify, collect, enhance, implement, and adopt may of these best practices as documented and standardized GRPs that can be shared among all review division 28 March 2011 Department of Pharmaceutics 109
  110. 110. − Quality — Consistent implementation of GRPs by review staff will enhance the quality of reviews, the review process, and the resultant regulatory action. − Efficiency — GRPs will improve the efficiency of the review process through standardization. − Clarity — GRPs support clarity throughout the review process, including critical review and decision activities that must be completed before a regulatory decision is made. 28 March 2011 Department of Pharmaceutics 110 GRPs Fundamental Values
  111. 111. GRPs Fundamental Values − Transparency — Developing and documenting GRPs ensures that our review processes are readily available in one location via the Internet (through CDER’s Web site) to sponsors and the public. − Consistency — By offering a consistent approach and only deviating from it when appropriate (after supervisory concurrence), GRPs help reviewers achieve consistency with their reviews and provide standard review processes across divisions and offices. 28 March 2011 Department of Pharmaceutics 111
  112. 112. cGxP 28 March 2011 Department of Pharmaceutics 112
  113. 113. cGxP • A "c" or "C" is sometimes added to the front of the acroynm. • The preceding "c" stands for "current." • For example, cGMP is an acronym for "current Good Manufacturing Practices." cGMP is the most well known example of a GxP. • The term GxP is only used in a casual manner, to refer in a general way to a collection of quality guidelines. 113Department of Pharmaceutics28 March 2011
  114. 114. cGxP • What does cGxP stand for? • Current Good X Practice (FDA compliance; X can mean: Manufacturing, Clinical, Laboratory, Storage, Distribution, Review Pharmaceutical) 114Department of Pharmaceutics28 March 2011
  115. 115. 28 March 2011 Department of Pharmaceutics 115 Thank you Cell No: 00919742431000 E-mail: bknanjwade@yahoo.co.in

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