AUDITABLE DATA AND REGULATORY AFFAIRS
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The document discusses requirements and guidelines for preparing auditable dossiers, including Common Technical Document (CTD) and Active Substance Master File (ACTD) dossiers. It outlines the modules and sections that make up each type of dossier, including administrative information, quality summaries, clinical and non-clinical study reports. It provides details on what should be included in each section or module, such as protocols, analytical reports, specifications and validation data. The presentation emphasizes that complete documentation and traceability of all studies and data is essential for an auditable dossier.
AUDITABLE DATA AND REGULATORY AFFAIRS
- 1. AUDITABLE DATA AND DOSSIERS REGULATORY AFFAIRS Presented By: Dr. Jibran Khan
- 2. AGENDA Standard criteria for International Dossier preparation. Departmental requirements and conditions to prepare Auditable Dossiers. Auditable Dossiers (ACTD / CTD/All Dossiers)
- 3. CTD DOSSIER The CTD is organized into five modules: Module 1 is region specific. Modules 2, 3, 4, and 5 are intended to be common for all regions. Module 1. Administrative Information and Prescribing Information Should contain documents specific to each region; e.g. application forms or the proposed label for use in the region. The content and format of this module can be specified by the relevant regulatory authorities. Module 1: Administrative Information and Prescribing Information 1.1 Table of Contents of the Submission Including Module 1 1.2 Documents Specific to Each Region (for example, application forms, prescribing information)
- 4. CTD DOSSIER Module 2. Common Technical Document Summaries 2.1 Common Technical Document Table of Contents (Modules 2-5) 2.2 CTD Introduction 2.3 Quality Overall Summary 2.4 Non-clinical Overview 2.5 Clinical Overview 2.6 Non-clinical Written and Tabulated Summaries Pharmacology Pharmacokinetics Toxicology 2.7 Clinical Summary Biopharmaceutical Studies and Associated Analytical Methods Clinical Pharmacology Studies Clinical Efficacy Clinical Safety Literature References Synopses of Individual Studies
- 5. CTD DOSSIER Module 3. Quality Information on Quality should be presented in the structured format described in Guideline M4Q. Module 3: Quality 3.1 Table of Contents of Module 3 3.2 Body of Data 3.3 Literature References
- 6. CTD DOSSIER Module 4. Non-clinical Study Reports The non-clinical study reports should be presented in the order described in Guideline M4S. Module 4: Non-clinical Study Reports 4.1 Table of Contents of Module 4 4.2 Study Reports 4.3 Literature References
- 7. CTD DOSSIER Module 5. Clinical Study Reports The human study reports and related information should be presented in the order described in Guideline M4E. Module 5: Clinical Study Reports 5.1 Table of Contents of Module 5 5.2 Tabular Listing of All Clinical Studies 5.3 Clinical Study Reports 5.4 Literature References
- 8. ACTD DOSSIER
- 9. P- PART (ACTD GUIDELINE) Drug Product : P1 Description and Composition P 1.1 Components of the Drug Product Description, Dosage form, Diluents (If any), Type of container closure. P 1.1.1 Active Ingredient Name, Quantity, Function, Reference Specs. P 1.1.2 Excipients Name, Quantity, Function, Reference Specs.
- 10. P- PART (ACTD GUIDELINE) Drug Product : P2 : Pharmaceutical Development P2.1 Information on Development Studies. Innovator specs with Invoice. Innovator Bench mark Sample. Data on development. General Protocol along with Product development Protocol.
- 11. P- PART (ACTD GUIDELINE) Drug Product : P2 : Pharmaceutical Development P2.1 Information on Development Studies. Trial management (success full Batches Analytical Reports along with complete data). Trial management (Failed Batches Analytical Reports along with complete data). Dose Proportionality in Batches . Calibration of Equipment's/ Instruments. Qualification/ Requalification of Equipment's / Instruments.
- 12. P- PART (ACTD GUIDELINE) Drug Product : P2 : Pharmaceutical Development P2.1 Information on Development Studies. Reproducible batches management ( Analytical Reports along with complete data). Microbiological Testing of Reproducible Batches ( Analytical Reports along with complete data). Reproducible Batches Stability. ( Analytical Reports along with complete data)
- 13. P- PART (ACTD GUIDELINE) Drug Product : P2 : Pharmaceutical Development P2.1 Information on Development Studies. Pilot batch (1 Lac tabs or 10% of Commercial Batch) Analytical Testing reports of Pilot Batch Pilot Batches Stability. ( Analytical Reports along with complete data) Dosage Form, Formulation, manufacturing process, Container closure system. Microbiological attributes
- 14. P- PART (ACTD GUIDELINE) Drug Product : P2 : Pharmaceutical Development P2.2 Components of the Drug Product. P2.2.1 Active Ingredients Approved Source of API DMF from approved sources and according to Ref Specs. GMP Certificate of Manufacturer . MSDS with invoices. Justification of Compatibility with Excipients and with Diluents
- 15. P- PART (ACTD GUIDELINE) P2 : Pharmaceutical Development P2.2 Components of the Drug Product. P2.2.2 Excipients Justification of the choice of excipients Details of excipients Manufacturer P2.3 Finished Product P2.3.1 Formulation Development P2.3.2 Overages. P2.3.3 Physiochemical and Biological Properties. P2.4 Manufacturing Process development
- 16. P- PART (ACTD GUIDELINE) Drug Product : P2 : Pharmaceutical Development P2.5 Container Closure System. P2.6 Microbial Attributes P2.7 Compatibility Compatibility of the finished Product with reconstitution diluents.
- 17. P- PART (ACTD GUIDELINE) Drug Product : P2 : Pharmaceutical Development Mandatory Requirements: 1- Head Count. 2- Qualification / Requalification of Equipment's / Instruments from Engineering. 3- Sufficient quantity of API is required to manufacture Trial/ Reproducible/Pilot batches as per guideline. 4- Requisition from marketing. 5- Approved source of API along with reference standard testing method / Excipients. (DMF and COAs of raw material (Current Pharmacopeia, GMP Certificate of Manufacturer, MSDS with invoices). 6- Innovator specs with invoice.
- 18. P- PART (ACTD GUIDELINE) Drug Product : P2 : Pharmaceutical Development Mandatory Requirements: 7- Innovator bench mark samples. 8- Proper trial management record with successful and failed trails along with analytical testing reports and data (Record, hardcopy and soft copy both). 9- Proper record management of 3 reproducible batches, along with complete analytical testing record including stability reports and data. 10- Proper record management of Pilot batch, batch size should be of 100000 tablets or 10% of Batch size (If batch size is greater than 1Lac) along with complete analytical testing record including stability reports and data.
- 19. P- PART (ACTD GUIDELINE) Drug Product : P2 : Pharmaceutical Development Mandatory Requirements: 11- Complete testing record of reproducible batches along with microbiological testing data from QC. 12- For commercial scale manufacturing, development of proper updated BMR required. 13- FPS and Stability specs would be produced on the basis of Trial #03 and Reproducible 01, 02, 03 applicable on complete dossier. 14- Container closure system and Compatibility will be finalized on the basis of stability testing and chemical testing of Reproducible 01, 02, and 03. Required complete testing data, reports with graphs.
- 20. P- PART (ACTD GUIDELINE) Drug Product : P2 : Pharmaceutical Development Mandatory Requirements: 15- In case of source change of Active material and packaging ; above mentioned procedure will be re applicable . 16- Back Up data collection is mandatory for complete procedure; all documents should be available in hard and soft copy with accessible traceability.
- 21. P- PART (ACTD GUIDELINE) Drug Product : P3 : Manufacture P3.1 Batch Formula (Batch size is not standard) P3.2 Manufacturing Process and Process Control P3.3 Control of Critical Steps P3.4 Process Validation and Evaluation Documentation (Protocol and Report) Results of Validation(Complete data, Evaluation Studies) Critical Steps and Assays used in Manufacturing
- 22. P- PART (ACTD GUIDELINE) P4 : Control of Excipients P4.1 Specs of Excipients with Compendial requirements Manufacturer COAs with details P4.2 Analytical Procedures P4.3 Excipients of Animal and Human Origin Information regarding source and adventurous material Compendial requirements and Information
- 23. P- PART (ACTD GUIDELINE) P4 : Control of Excipients P4.4 Novel Excipients Full details of manufacturer Characterization and Control Supporting Safety Data
- 24. P- PART (ACTD GUIDELINE) P5 Control of finished Product P 5.1 Specifications Specifications P 5.2 Analytical Procedure
- 25. P- PART (ACTD GUIDELINE) Drug Product : P5 Control of Finished Product P 5.3 Validation of Analytical Procedures Complete information regarding data including experimental data. Verification of Method. Calibration and qualifications of equipment's P5.3.1 Assay method validation P5.3.2 Dissolution method validation P5.3.3 Related Substance method validation
- 26. P- PART (ACTD GUIDELINE) Drug Product : P5 Control of Finished Product P 5.4 Batch Analysis COA Testing data and report. P5.5 Characterization of Impurities Information on Characterization of Impurity
- 27. P- PART (ACTD GUIDELINE) Drug Product : P5 Control of Finished Product P 5.6 Justification of Specifications Justification of purposed Specifications Complete Compendial Requirements Information from manufacturer P6 Reference Standard or material Complete information Compendial requirements along with primary standard.
- 28. P- PART (ACTD GUIDELINE) Drug Product : P7 Container Closure System Specifications Approved Art work Control of Primary and secondary Packaging Type of Packaging along with Packaging material Packaging Size and details of Packaging inclusion (e.g. Desiccant) Testing reports of Packaging material
- 29. P- PART (ACTD GUIDELINE) Drug Product : P8 Stability Specifications Stability protocol as per marketing requirement Stability Raw Data Testing Report along with Graphs (Un auditable) Commitment on Post approval stability P9 Product interchangeability Equivalence evidence In vitro Comparative dissolution study (as required In Vivo Bioequivalence (study as required)