Abstract
D&MD' s Preparing the Common Technical Document (CTD) for CMC provides a detailed description and analysis of the regulations, requirements and strategy for preparing a CTD. The focus of this publication is on the sections of Module 3 that demonstrate to “quality” of the candidate drug substance and product to the satisfaction of regulators
Table of Contents
CHAPTER 1: INTRODUCTION
- Scope of this Guide
- Brief History of US Drug Regulation
- Drug Regulatory Law
- Drug Approval
- Biologic Products
- The International Conference on Harmonization
CHAPTER 2: THE CTD FORMATTED IND
- The CTD Format
- Preparing the CMC Sections of the CTD
- Preparing the CMC Sections of the CTD
- Module 2: Common Technical Document Summaries
- Module 3: Quality
- CMC Topic Coverage
- Formulating a Strategy
- CMC Requirements for Biopharmaceuticals
- Step One-Which FDA Center is involved
- Step Two-Establishing a time line
- Step Three-Think like a Regulator
CHAPTER 3: ELEMENTS OF CGMP REGULATIONS
- Quality Assurance in Drug Manufacturing & Testing
- What are Standard Operating Procedures?
- Guide to Writing SOPs
CHAPTER 4: ASSAY DESIGN
- Introduction ...
- Definitions
- Assays and Analytes
- Qualitative and Quantitative
- Drug Development and Manufacturing
- Impurities
- Therapeutics
- Universal Considerations
- Precision
- Time
- Washing
- Other Sources of Non-reproducibility
- Repeatability between Labs
- Optimal Reagent Amounts
- Serial Dilutions
- Standard Curves
- Linearity
- Data Analysis
- Multiplicity
- Signal-to-background and Signal-to-noise Ratios
- Z-prime
- Nature of Analyte and Matrix
- Analyte Stability
- Microbial Contamination
- Metabolic Processes
- Intractable Stability Problems
- Separation and Enrichment
- Internal Standard “Spike”
- Assay Objectives
- Research, Development, or Process
- Scalability
- Sensitivity
- Error Tolerance
- Assay Validation
- validation
- Installation and Operation Qualification
- Instruments and Equipment
- Assay Optimization
- Factorial Design
- Other Variables
- Performance Qualification
- Instruments and Consumables
- Operation Re-certification
- Assay Parameters
- Data Certification
- Checklist for General Assay Development
- General
- Sample
- Data
- Standard Checklist To Be Used for Any Assay Development
- Statistics Review
- Correlation Coefficient
- Standard Deviation
- Coefficient of Variance
- Z' Factor
- More Complicated Statistics
- Error Detection
- Error Correction
- Normalization and Data Condensing
- Data Standardization
- Statistical Analysis
APPENDIX 1: NEW DRUGS, SEC. 505
APPENDIX 2: SECTION LIST OF 21CFR 211
APPENDIX 3: QUALITY SYSTEMS APPROACH TO PHARMACEUTICAL CGMP REGULATIONS
TABLE OF EXHIBITS
- Exhibit 2.1 Diagrammatic Representation of the ICH Common Technical Document
- Exhibit 2.2 IND Process and Review Procedures of the CDER, Manual of Policies and Procedures - MAPP 6030.1
- Exhibit 3.1 The Drug Development Pathway
- Exhibit 3.2 What is Quality Assurance?
- Exhibit 4.1 Major Assay Design Considerations and Potential Problems Addressed
- Exhibit 4.2 Common Causes of Assay Non-reproducibility
- Exhibit 4.3 Sample Standard Curve with Data Interpolation, Extrapolation
- Exhibit 4.4 Parameters for the Validation of Different Types of Analytical Method
- Exhibit 4.5 Example of Factorial Design
- Exhibit 4.6 Ordered Steps for Quality Control of UHT Data
