Standard operating procedure for CTA

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Standard operating procedure for CTA

  1. 1. Project Management Assignment RAC – 203 RAC 203/TIPT/Project Management
  2. 2. Areas of Concern in CTA RAC 203/TIPT/Project Management
  3. 3. INTRODUCTION SOP is a valuable tool for the preparation of a CTA to Health Canada. It provides the procedural description of materials and methods Provides details of appropriate quality, cost and time constraints. It is prepared based on the principles of project management. In general, SOP provides the user to think through the procedure step by step and to standardize the materials, methods, cost and time. RAC 203/TIPT/Project Management
  4. 4. CONTENTS OF SOP FOR CLINICAL TRIAL APPLICATION RAC 203/TIPT/Project Management
  5. 5. Project Charter SOP of Clinical Trials Application Project Overview  Problem StatementIt is designed to provide tools and relevant links in order to facilitate the successful filing of a Clinical Trial Application (CTA) to Health Canada  Project Description This SOP will be a tool for filling of Clinical Trial Application for Health Canada avoiding any discrepancies in understanding of documents and requirements of Health Canada  Project Goals and Objectives It is designed to provide tools and relevant links in order t o facilitate the successful filing of a Clinical Trial Application (CTA) to Health Canada. It is based on Health Canada’s Guidance for Clinical Trials.  Project Justification The information provided within this package is for clinical trials that involve the use of Pharmaceutical and/or Biological and Radiopharmaceutical drugs in human subjects. RAC 203/TIPT/Project Management
  6. 6. Project Charter SOP of Clinical Trials Application Assumptions Sponsors conducting clinical trials in Canada with products that have received a Notice of Compliance with Conditions (NOC/c) are also required to file a CTA the product is outside the parameters of the authorized Notice of Compliance (NOC) or Drug Identification Number (DIN) application . Constraints Project constraints being imposed in areas such as schedule, budget, resources, products to be reused, technology to be employed, products to be acquired, and project constraints based on the current knowledge today interfaces to other products. RAC 203/TIPT/Project Management
  7. 7. Project Charter SOP of Clinical Trials Application PROJECT SCOPE RAC 203/TIPT/Project Management
  8. 8. Scope Planning Process RAC 203/TIPT/Project Management
  9. 9. SCOPE DEFINITION The information provided within this package is for clinical trials that involve the use of Pharmaceutical and/or Biological and Radiopharmaceutical drugs in human subjects. RAC 203/TIPT/Project Management
  10. 10. WBS: Inputs, Tools & Techniques, Outputs RAC 203/TIPT/Project Management
  11. 11. RELATIONSHIP BETWEEN STAKEHOLDERS AND THE PROJECT RAC 203/TIPT/Project Management
  12. 12. Stakeholder’s Flow chart RAC 203/TIPT/Project Management
  13. 13. WBS: Inputs, Tools & Techniques, Outputs RAC 203/TIPT/Project Management
  14. 14. Clinical Trial Application (CTA)  A must to file Clinical Trial Application (CTA) to conduct clinical trials in Phases I through III of  Drug development and  Comparative bioavailability trials. This includes applications to conduct clinical trials involving marketed products where the proposed use of the product is outside the parameters of the authorized drugs.  A similar Health Canada review and approval process exists for clinical trials involving natural health products. Under the Natural Health Products Regulations, which came into effect on January 1, 2004.  Natural health products (NHPs) are defined as:  * Vitamins and minerals * Herbal remedies * Homeopathic medicines * Traditional medicines such as traditional Chinese medicines * Probiotics, and * Other products like amino acids and essential fatty acids.  Submissions satisfying the NHP Directorate's requirements will be issued a Notice of Authorization to commence the trial. RAC 203/TIPT/Project Management
  15. 15. Clinical Trial Application (CTA) It is a mandatory requirement of Health Canada that Sponsor must file a Clinical Trial Application (CTA) to conduct clinical trials in Phases I through III of drug development and comparative bioavailability trials. The first step for the successfully filing of a CTA is a well-documented procedure that ensures that everyone involved is well aware of the documentation methods RAC 203/TIPT/Project Management
  16. 16. TYPES OF CLINICAL TRIALS RAC 203/TIPT/Project Management
  17. 17. Outline of a CTA / CTA-A RAC 203/TIPT/Project Management
  18. 18. Outline of a CTA / CTA-A RAC 203/TIPT/Project Management
  19. 19. IMPORTANT IMPORTANT: Each Module should be submitted in a separate binder. The modules are organized and numbered consistently in an internationally adopted format - the Common Technical Document (CTD). Adhering to the CTD format facilitates evaluation by Health Canada and ensures consistency of documents in subsequent stages of the drug authorization process. Additional information about the CTD format is available on the web site of the International Conference on Harmonisation (ICH) at www.ich.org. The CTA should be sent directly to the appropriate Directorate. The outer label should be clearly state "Clinical Trial Application". RAC 203/TIPT/Project Management
  20. 20. RAC 203/TIPT/Project Management
  21. 21. RAC 203/TIPT/Project Management
  22. 22. Planning of Alternative Process RAC 203/TIPT/Project Management
  23. 23. Barriers to introduction of new medical product RAC 203/TIPT/Project Management
  24. 24. COST ESTIMATION RAC 203/TIPT/Project Management
  25. 25. Project Cost Management overview RAC 203/TIPT/Project Management
  26. 26. COST : WORK BREAKDOWN STRUCTURE RAC 203/TIPT/Project Management
  27. 27. WBS: Inputs, Tools & Techniques, Outputs RAC 203/TIPT/Project Management
  28. 28. MILESTONE LIST RAC 203/TIPT/Project Management
  29. 29. Cost Control Chart RAC 203/TIPT/Project Management
  30. 30. Three modules for CTA IMPORTANT: Each Module should be submitted in a separate binder. The modules are organized and numbered consistently in an internationally adopted format the Common Technical Document (CTD). Adhering to the CTD format facilitates evaluation by Health Canada and ensures consistency of documents in subsequent stages of the drug RAC 203/TIPT/Project Management
  31. 31. PROJECT QUALITY MANAGEMENT Project quality management ensures that the project satisfies the stated or implied Level of quality and the key out puts of quality management includes: 1. Quality Management Plan 2. Quality matrices 3. Quality Check list RAC 203/TIPT/Project Management
  32. 32. QUALITY Good manufacturing practices: main principles for pharmaceutical products Quality management in the drug industry: philosophy and essential elements Heating Ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms Validation Water for pharmaceutical use RAC 203/TIPT/Project Management
  33. 33. QUALITY . Good manufacturing practices: starting materials Active pharmaceutical ingredients (bulk drug substances) Pharmaceutical excipients RAC 203/TIPT/Project Management
  34. 34. QUALITY Inspection Pre-approval inspections Inspection of pharmaceutical manufacturers Inspection of drug distribution channels Quality systems requirements for national good manufacturing practice inspectorates Guidance on good manufacturing practices: Inspection report Model certificate of good manufacturing practices RAC 203/TIPT/Project Management
  35. 35. QUALITY Good manufacturing practices: specific pharmaceutical products Sterile pharmaceutical products Biological products Investigational pharmaceutical products for clinical trials in humans The manufacture of herbal medicines Radiopharmaceutical products RAC 203/TIPT/Project Management
  36. 36. QUALITY Hazard and risk analysis in pharmaceutical products Application of hazard analysis and critical control point (HACCP) methodology to pharmaceuticals. Sampling operations Sampling of pharmaceutical products and related materials RAC 203/TIPT/Project Management
  37. 37. Defined Conditions for Impact Scales of risk on Major Project Objectives RAC 203/TIPT/Project Management
  38. 38. SOPs and Records (a) Equipment assembly and validation; (b) Analytical apparatus and calibration; (c) Maintenance, cleaning and sanitization; (d) Personnel matters including qualification, training, clothing and hygiene; (e) Environmental monitoring; (f ) Pest control; (g) Complaints; (h) Recalls; (i) Returns. RAC 203/TIPT/Project Management
  39. 39. SOPs and Records SOP for the internal labelling, quarantine and storage of starting materials, packaging materials and other material. SOP should be available for each instrument and piece of equipment (e.g. use, calibration, cleaning, maintenance) . Standard operating procedures for sampling. SOP with details of the batch (lot) numbering system Batch-number allocation should be immediately recorded, e.g. in a logbook. RAC 203/TIPT/Project Management
  40. 40. SOPs and Records Analysis records should include at least the following data:  (a) The name of the material or product and, where applicable, dosage form;  (b) The batch number and, where appropriate, the manufacturer and/or supplier;  (c) References to the relevant specifications and testing procedures;  (d) Test results, including observations and calculations, and reference to any specifications (limits);  (e) Date(s) and reference number(s) of testing;  (f ) The initials of the persons who performed the testing;  (g) The date and initials of the persons who verified the testing and the calculations, where appropriate;  (h) A clear statement of release or rejection (or other status decision) and the dated signature of the designated responsible person. RAC 203/TIPT/Project Management
  41. 41. SOPs and Records  The records of the receipts should include:  (a) The name of the material on the delivery note and the containers;  (b) The “in-house” name and/or code of the material if different from (a);  (c) The date of receipt;  (d) The supplier’s name and, if possible, manufacturer’s name;  (e) the manufacturer’s batch or reference number;  (f ) The total quantity, and number of containers received;  (g) The batch number assigned after receipt;  (h) Any relevant comment (e.g. state of the containers). RAC 203/TIPT/Project Management

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