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C TA - standard operating procedures

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Standard Operating Procedures ( SOP) in Clinical Research

Standard Operating Procedures ( SOP) in Clinical Research

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    C TA - standard operating procedures C TA - standard operating procedures Document Transcript

    • SOP for Clinical Trial Application Standard Operating Procedures Clinical Trial Application (CTA) Project Management Assignment RAC – 203 INSTRUCTOR Prof. Ramjeet Prepared by Page 1 Rajeev Kashyap RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application Project Charter SOP of Clinical Trials Application Version # RK/RAC-203-1 Revision Date 05September 2009 Approval of the Project Charter indicates an understanding of the purpose and content described in this deliverable. By signing this deliverable, each individual agrees. APPROVER NAME SIGNATURE TITLE DATE Mission: Adherence to GMP/GLP following ICH guidelines in manufacturing and safety of drugs. Page 2 Vision: Target delivery system of quality drugs within affordable costs. RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application PROJECT CHARTER Project Title Project Start Date Project Finish Date Standard Operating Procedure for CTA September 14,2009 October 30,2009 Budget Information Project Manager $ 72,520.00 (Approved) Mary Palmer Project objective Develop a standard operating procedure for Clinical Trial Application *Communicate with all departments *Work closely with QC department *Collect all documents necessary for CTA *Monitor document; are complete and accurate Approach Page 3 Roles and Responsibilities Name and Role Position Contact Information Signature Kathleen Project Vice 416 241 AZYX Thompson, champion President (signed) Mary Palmer Project Director 416 221 WVUT (signed) Sponsor Laura Butler Project Manager 416 422 SRQP (signed) Laura Butler Steering committee member 416 532 ONML (signed) Colleen James Team Leader 416 443 KJIH (signed) Karen Kellner Supplier management 416 324 GFED (signed) Approval of the Project Charter indicates an understanding of the purpose and content described in this deliverable. By signing this deliverable, each individual agrees to it. RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application CONTENTS OF SOP FOR CLINICAL TRIAL APPLICATION Section 1 1 . 1 Project Statement 1. 2 Project Description 1 . 3 Project Goals and Objective 1 . 4 Project Scope 1 . 5 Critical Success Factors 1 . 6 Assumptions 1 . 7 Constraints. Section 2 Project Authority and Milestones 2 .1 Project Funding Authority 2 .2 Project Oversight Authority 2 .3 Major Project mile stones Section 3 Project Organization 3.1 Project Structure 3.2 Roles and Responsibilities 3. 3 Project Facilities & Resources Section 4 4.1 Point of Contact Section 5 Glossary Section 6 Revision History Section 7 Page 4 Appendices RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application Section 1. Project Overview 1.1 Problem Statement It is designed to provide tools and relevant links in order to facilitate the successful filing of a Clinical Trial Application (CTA) to Health Canada. 1.2 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 1.3 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. 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. The information does not apply to clinical trials involving Medical Devices and Natural Health Products. INPUTS TOOLS & TECHNIQUES OUTPUTS Organizational process assets Product analysis Project Scope Statement Project Charter Alternatives identification Requested Changes Project Scope Statement Expert judgements Project Scope management Plan Stakeholders judgements Project Scope management plan(updates) Approved change requests Page 5 SCOPE DEFINITION: Input, Tools and Technique, and Outputs RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application 1.4 Project Scope 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. The information does not apply to clinical trials involving Medical Devices and Natural Health Products. Project Includes Project Excludes PROJECT ORGANIZATION The project sponsor will make all major decisions in consultation with project champion and steering committee member. Project Manager is responsible for the successful completion of the project. Team leaders and Supplier project managers report to the Project Manager Project Sponsor Mary Palmer Brian Bretz Team Leaders Colleen James RK/RAC/203/14/09/2009 Version 1 Project Champion Kathleen Thompson, Supplier Management 6 Laura Butler Project Manager Page Steering committee Karen Kellner Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application RELATIONSHIP BETWEEN STAKEHOLDERS AND THE PROJECT PROJECT STAKEHOLDERS PROJECT TEAM PROJECT MANAGEMENT TEAM PROJECT SPONSOR & PROJECT MANAGER Duties and Responsibilities PROJECT ORGANIZATION: DUTIES AND RESPONSIBILITIES Project Sponsor Final decision making authority. Consults Mary Palmer Project champion and steering committee Project Champion Advise project sponsor Kathleen Thompson, Steering committee Advise project sponsor Laura Butler Responsible for the success of the project Project Manager Brian Bretz Team Leaders Report to project Manager Supplier Management Report to project Manager RK/RAC/203/14/09/2009 Version 1 Page Karen Kellner 7 Colleen James Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application STAKEHOLDER ANALYSIS Stakeholder analysis provides information about key stakeholders to help manage relationships with them External Stakeholders Health Canada  Reviews clinical trial protocols to assess the protection and safety of the participants  Assesses the quality of the drugs  assures review by Research Ethics Boards  verifies the qualifications of Principal Investigators and monitors and reviews  Adverse Drug Reactions (ADRs). Sponsor  In compliance with the Canadian Food and Drug Regulations, Division 5  Adheres to good clinical practices for the proper use of the drugs,  Record keeping Reporting of Considers ethical issues Protocol Adverse Drug Reactions (ADRs). Research Ethics Board The informed consent documents Conflicts of interest Financial agreements. Internal Stakeholders Project Sponso Project Champion Steering committee members Project Manager RA Manager Team Leaders Project management Lead Page 8 Supplier Management RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application Stakeholders Internal External Health Canada Project Sponsor Kathleen Thompson, Mary Palmer Steering committee Project Champion Laura Butler Kathleen Thompson, Project Manager RA Brian Bretz REB Sonia Barragan Project Management Jeanne Heschele Mila Dacorro Suppliers Tiffany Binderup Group Team Leaders Colleen James Supplier Management Karen Kellner Stakeholder’s Flow chart Standard Operating Procedures Clinical Trial Application (CTA) A CTA contains information and documentation to support the objectives and goals of the proposed clinical trial. It also includes data to support the drug product quality. The clinical and quality components of the application are reviewed in parallel and both must be satisfactory before a No Objection Letter can be issued. Sponsors must file a Clinical Trial Application (CTA) to conduct clinical trials in Phases I through III of drug development and comparative bioavailability trials. RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology Page SOP is an authorized written procedure giving instructions for performing operations not necessarily specific to a given product or material (e.g. equipment operation, maintenance and cleaning; validation; cleaning of premises and environmental control; sampling and inspection). 9 This includes applications to conduct clinical trials involving marketed products where the proposed use of the product is outside the parameters of the authorized
    • SOP for Clinical Trial Application Certain SOPs may be used to supplement product-specific master and batch production documentation SAFETY QUALITY EFFICASY SCOPE Project Justification 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 welldocumented procedure that ensures that everyone involved is well aware of the documentation Page 10 methods. RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application SCOPE PLANNING SCOPE CREATE WBS DEFINITION SCOPE CONTROL 1.5 SCOPE VERIFICATION Critical Success Factors The Food and Drugs Act and Regulations provide authority to Health Canada to regulate the sale of drugs for the purposes of use in human clinical trials. Part C, Division 5 of the Regulations defines specific Clinical Trial Application (CTA) and Clinical Trial Application Amendment (CTA-A) requirements for the sale and importation of drugs for use in human clinical trials in Canada. Division 5 of the Regulations came into force since September 2001 and was developed to recognize the generally accepted principles of good clinical practice The Regulations are consistent with the principles, definitions and standards found in the  Health Canada / ICH Guidance Documents E6: Good Clinical Practice: Consolidated Guideline,  E8: General Considerations for Clinical Trials and  E2A: Clinical Safety Data Management:  Definitions and Standards for Expedited Reporting. This guidance documents, developed through the International Conference on Harmonisation (ICH) process have been adopted by Health Canada. Together, they define parameters for the  Conduct  Performance RK/RAC/203/14/09/2009 Version 1 11 Design Page  Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application  Monitoring  Auditing,  Recording, analysis  Reporting of clinical trials. 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. 1.6 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 Page 12 Identification Number (DIN) application . RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application 1.7 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. 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". DOCUMENT NOT INCLUDED IN THESE MODULES SHOULD NOT BE FILED AND IT IS OUT OF PROJECT SCOPE. 3.3 Project success: Studies conducted by the sponsor have stated that the project will be a success if it can be completed within 50 days. 3.4 Deliverables; Team Contract Project management plan 13 Scope statement Page Work breakdown Structure Standard operating Procedure RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application Clinical Trial Application (CTA) The CTA is composed of three parts (modules): Outline of a CTA / CTA-A Module Pharmaceuticals 1 Administrative / Clinical Information 1.1 Table of Contents (Modules 1-3) 1.2 Biologicals and Radiopharmaceuticals Application Information Drug Submission Application Form (HC/SC 3011) 1.2.1 1.2.2 1.2.3* 1.2.4* Information on Prior-related Applications Investigator’s Brochure Protocol Synopsis (PSEAT-CTA) Study Protocol(s) Informed Consent Document(s) Clinical Trial Site Information Canadian Research Ethics Board(s) Refusals Foreign Refusals 1.2.10 Letters of Access Other Application-related Information Electronic Review Documents 1.3 2 Page 1.2.11 14 1.2.5* 1.2.6 1.2.7 1.2.8 1.2.9 Submission Rationale / Brief Summary of the Drug Product Common Technical Document Summaries RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application 2.1 2.3 2.3⁷* 3 3.1 3.2 Common Technical Document Table of Contents .............. Quality Overall Summary Quality Table of Contents of Module 3 Body of Data 3.2.R.1 Production Documentation 3.2.R.2 Executed Batch Records Literature References 3.3 * These items should be submitted in hard copy and in electronic format accepted by Health Canada ( CD - ROM) TIME MANAGEMENT The start date of the project is September 14, 2009 and the Finish date is October 30, 2009. The total duration for this project is 35 days. A work breakdown structure at level 2 is given below. MS Project software or any other validated program must be used for this task. Page 15 7.1 Gantt Chart Activity List: Level 2 RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • Page 16 SOP for Clinical Trial Application RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • 17 SOP for Clinical Trial Application RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Page 7.2 Gantt chart: Activity List Level 3 : Standard Operating Procedure for CTA Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application The WBS at level 3 is given in the above Gantt Chart Milestones At completion of a specific set of documentation milestones are given to review project progress. There are 10 milestones for this project. The following Gantt chart lists the dates of each milestone MILESTONE LIST Standard Operating Procedure for CTA Milestone List Activity Milestone Date 2.Study Correspondence 0d Mon 28/09/09 Mon 28/09/09 "6,10SS"RA Mon 05/10/09 Mon 05/10/09 21SS RA "Correspondence: letters, faxes, memos, emails" 0d Fri 09/10/09 Fri 09/10/09 30SS RA "Correspondence: letters, faxes, memos, emails" 0d Mon 12/10/09 Mon 12/10/09 44SS RA RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology 18 0d Page "Correspondence: letters, faxes, memos, emails"
    • SOP for Clinical Trial Application "Correspondence: letters, faxes, memos, emails" 0d Tue 13/10/09 Tue 13/10/09 61SS RA "Correspondence: letters, faxes, memos, emails" 0d Thu 15/10/09 Thu 15/10/09 88SS RA "Correspondence: letters, faxes, memos, emails" 0d Tue 20/10/09 Tue 20/10/09 106SS RA "Correspondence: letters, faxes, memos, emails" 0d Thu 22/10/09 Thu 22/10/09 117SS RA "Correspondence: letters, faxes, memos, emails" 0d Mon 26/10/09 Mon 26/10/09 141SS RA "Correspondence: letters, faxes, memos, emails" 0d Wed 28/10/09 Wed 28/10/09 148SS RA 8.0 COST MANAGEMENT Project cost management includes the process required to ensure that a project team completes a project within in an approved budget. TIME MANAGEMENT The start date of the project is September 14, 2009 and the Finish date is October 30, 2009. The total duration for this project is 35 days. A work breakdown structure at level 2 is given below. MS Project software or any other validated program must be used for this task. Page 19 Gantt Chart Activity List: Level 2 RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • Page 20 SOP for Clinical Trial Application RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • Page 21 SOP for Clinical Trial Application 7.2 Gantt chart: Activity List Level 3 : Standard Operating Procedure for CTA RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application The WBS at level 3 is given in the above Gantt Chart 7.3 Milestones At completion of a specific set of documentation milestones are given to review project progress. There are 10 milestones for this project. The following Gantt chart lists the dates of each milestone MILESTONE LIST Page 22 Standard Operating Procedure for CTA RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application 7.4 Milestone List Activity Milestone Date 2. Study Correspondence 0d Mon 28/09/09 Mon 28/09/09 "6,10SS"RA "Correspondence: letters, faxes, memos, emails" 0d Mon 05/10/09 Mon 05/10/09 21SS RA "Correspondence: letters, faxes, memos, emails" 0d Fri 09/10/09 Fri 09/10/09 30SS RA "Correspondence: letters, faxes, memos, emails" 0d Mon 12/10/09 Mon 12/10/09 44SS RA "Correspondence: letters, faxes, memos, emails" 0d Tue 13/10/09 Tue 13/10/09 61SS RA "Correspondence: letters, faxes, memos, emails" 0d Thu 15/10/09 Thu 15/10/09 88SS RA "Correspondence: letters, faxes, memos, emails" 0d Tue 20/10/09 Tue 20/10/09 106SS RA "Correspondence: letters, faxes, memos, emails" 0d Thu 22/10/09 Thu 22/10/09 117SS RA "Correspondence: letters, faxes, memos, emails" 0d Mon 26/10/09 Mon 26/10/09 141SS RA "Correspondence: letters, faxes, memos, emails" 0d Wed 28/10/09 Wed 28/10/09 148SS RA WBS: Inputs, Tools & Techniques, Outputs OUTPUTS INPUTS Organisational process assets Project scope statement Project Scope Management Plan TOOLS & TECHNIQUES Work Breakdown Structure Template Decomposition Project scope statement(updates) WBS & WBS Dictonary Scope Baseline Project Scope management plan(updates) & requested Changes Page 23 Approved Change requests RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application 8.0 COST MANAGEMENT Project cost management includes the process required toensure that a project team completes a project within in an approved budget. 8.1 Project Cost Project team normally prepares cost estimates at various stages of the project and this estimates are fine tuned as time progress. 8.2 Bottom up Cost estimation To increase the accuracy of cost estimation a bottom up cost estimation method is followed for this project The current project cost is estimated to be $72,520. The cost WBS at level 2 is given in the following Gantt chart using MS Project program. Project Cost Management overview COST ESTIMATING •1. INPUT •Enterprise Enviornmental Factors •Organisational Process Assets •Project Scope Statement •WBS & WBS Dictionary •Project Management Plan : Schedule management plan, Staffing Management plan, Risk register. •2. TOOLS & TECHNIQUES •Analogous estimating. •Determine resourse cost rates •Bottom-up estimating. •Parameteric estimating •Project management software. •Vendor bid analysis •Cost of quality. •3. OUTPUTS •1. INPUTS •Project scope statement •WBS &WBS Dictonary •activity cost estimates •activity cost estimate supporting details •Project schedule •Resourse Calandars. •Contracts •Cost management plan •2. TOOLS & TECHNIQUES •Cost aggregation •Reserve analysis •Parametric estimating. •Funding limit reconcilition •3. OUTPUTS •Cost Baseline •Project funding requiements •Cost management plan (updates) •Request changes COST CONTROL •1. INPUTS •Cost baseline •Project funding requirements •Performance report •Work Performence inforfation •Approvd change request •Project management plan •2. TOOLS &TECHNIQUES •Cost change control system •Performance measuements analysis •Forecasting •Project performancce reviews •Project management software •Variance measurements •3. OUTPUTS •Cost estimate (updates) •Performance Measures •Cost baseline (updates) •Forecasted completion •Requested Changes •Recomended corrective actions •Organisational process assets •Project management plan(updates) Page 24 •Activity cost estimates •Activity cost estimate supporting details •Requested changes. •Cost management plan(updates) COST BUDGETING RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application Project cost Estimation Gantt Chart COST : WORK BREAKDOWN STRUCTURE SOP FOR CTA Cost Analysis Level 2.mpp 8.4 COST BUDGETING Project cost budgeting involves allocating the project cost estimate to various tasks The Cost budgeting based on WBS level 3 is to be carried out using MS Project software or any other validated system as given in the following Gantt. Chart. Page 25 Cost budgeting Gantt Chart RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • 26 SOP for Clinical Trial Application Page 8.1 Project Cost RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application Project team normally prepares cost estimates at various stages of the project and this estimates are fine tuned as time progress. 8.2 Bottom up Cost estimation To increase the accuracy of cost estimation a bottom up cost estimation method is followed for this project The current project cost is estimated to be $72,520. The cost WBS at level 2 is given in the following Gantt chart using MS Project program. 8.3 Project cost Estimation Gantt Chart COST : WORK BREAKDOWN STRUCTURE SOP FOR CTA Cost Analysis Level 2.mpp 8.4 COST BUDGETING Project cost budgeting involves allocating the project cost estimate to various tasks The Cost budgeting based on WBS level 3 is to be carried out using MS Project software or any other validated system as given in the following Gantt. Chart. Page 27 PROJECT QUALITY MANAGEMENT RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application 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 lists 9.1 Quality Management Plan The main goal of the project is to develop a Standard Operating Procedure for a CTA within the targeted time. By scheduling a suite of Quality Assurance Reviews, to be undertaken by an independent person to the project, the customer will be provided with a “trusted view” of the overall progress of the project and the likelihood of the deliverables actually meeting the quality targets agreed. All the procedures and procurements will be carried out as per established standards ie GMP, GLP, ICH and ISO standards 9.2 Matrices and Reporting A metric is a standard of measurement. Examples are customer satisfaction, failure rates and availability of service and goods. The quality management team at the site is responsible for actively identifying issues and trends to support continuous improvement. This is facilitated through the collection of quality and compliance Key Performance Indicators. The information collected could be from a variety of sources such regulatory audits, self inspections, trending reports or non-conformance quality systems monitoring programs. The site quality team is responsible for providing visibility of the quality information through appropriate forums, reports and communication channels. The quality and management teams and Corporate Quality and Operations management on a RK/RAC/203/14/09/2009 Version 1 Page scheduled basis. 28 compliance Key Performance Indicators are reviewed and reported to both the Project Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application 9.3 Quality Check list A list if items to be noted or consulted. It helps the project team to verify that a set of required steps has been performed. Whether reports are complete Whether suppliers are qualified or ISO certified Whether the reports are signed and dated. 9.4 Quality control measures 9.5 Control charts .control charts illustrates the progress of a task overtime Page 29 In this cost control chart mean amount is calculated from the total cost divided by number of days. Lower and upper limits are fixed for daily cost control. RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application Cost Control Chart 3000 Amount in $ 2500 Lower Limit 2000 Mean 1500 Upper Limit 1000 Daily expense Linear (Daily expense) 500 0 1 2 3 4 5 6 7 8 9 10 Days 9.6 Histograms A histogram showing number of tasks completed on a daily basis Page 30 Histograms show a bar graph of distribution of variables RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application QC HISTOGRAM Number of Tasks 16 14 12 10 8 6 4 2 0 1 2 3 4 5 6 7 8 9 10 HISTOGRAM Days 10.0 Conclusion. Project success is an intangible, realized through consensus, collaboration and communication. In this SOP best project management standards and practices are used to increase the likelihood of overall success. Throughout this project milestones are provided for the logical flow of project planning and execution, providing for periodic review and ongoing reflection. It will provide potential benefits, as defined checkpoints for management control and success of the project. Standard operating procedures (SOPs) and records  Standard operating procedures and associated records of actions taken or, where appropriate, conclusions reached should be available for: 31 (a) Equipment assembly and validation; Page (b) Analytical apparatus and calibration; (c) Maintenance, cleaning and sanitization; RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application (d) Personnel matters including qualification, training, clothing and hygiene; (e) Environmental monitoring; (f ) Pest control; (g) Complaints; (h) Recalls; (i) Returns.  There should be standard operating procedures and records for the receipt of each delivery of starting material and primary and printed packaging material.  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).  There should be standard operating procedures for the internal labelling, quarantine and storage of starting materials, packaging materials and other materials, as appropriate.  Standard operating procedures should be available for each instrument and piece of equipment (e.g. use, calibration, cleaning, maintenance) and placed in close proximity to the equipment.  There should be standard operating procedures for sampling, which specify the person(s) authorized to take samples.  The sampling instructions should include: (a) The method of sampling and the sampling plan; (b) The equipment to be used; (c) Any precautions to be observed to avoid contamination of the material or any Deterioration in its quality; (d) The amount(s) of sample(s) to be taken; (f ) The type of sample container(s) to be used, and whether they are for aseptic RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Page sampling or for normal sampling, and labelling; 32 (e) Instructions for any required subdivision of the sample; Toronto Institute of Pharmaceutical Technology
    • SOP for Clinical Trial Application (g) Any specific precautions to be observed, especially in regard to the sampling of sterile or noxious material.  There should be a standard operating procedure describing the details of the batch (lot) numbering system, with the objective of ensuring that each batch of intermediate, bulk or finished product is identified with a specific batch number.  The standard operating procedures for batch numbering that are applied to the processing stage and to the respective packaging stage should be related to each other.  The standard operating procedure for batch numbering should ensure that the same batch numbers will not be used repeatedly; this applies also to reprocessing.  Batch-number allocation should be immediately recorded, e.g. in a logbook. The record should include at least the date of allocation, product identity and size of batch.  There should be written procedures for testing materials and products at different stages of manufacture, describing the methods and equipment to be used. The tests performed should be recorded.  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.  Written release and rejection procedures should be available for materials and products, and in particular for the release for sale of the finished product by an authorized person.  Records should be maintained of the distribution of each batch of a product in order, e.g. to facilitate the recall of the batch if necessary. validations, calibrations, maintenance, cleaning, or repair operations, including dates and the identity of the people who carried these operations out. RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology 33 Records should be kept for major and critical equipment, as appropriate, of any Page 
    • SOP for Clinical Trial Application  The use of major and critical equipment and the areas where products have been processed should be appropriately recorded in chronological order.  There should be written procedures assigning responsibility for cleaning and sanitation and describing in sufficient detail the cleaning schedules, methods, equipment and materials to be used and facilities and equipment to be cleaned. Such written procedures should be followed. References. www.ich.org. RAC 203 Resource Materials Page 34 http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/cta_pre_applicationeng.php RK/RAC/203/14/09/2009 Version 1 Project Management Assignment Toronto Institute of Pharmaceutical Technology