The analytical development report is a documented summary with scientific justification of all essential analytical information acquired during the R&D phase of the project.
In many cases, this report serves a variety of purposes: it is a source document for the quality unit, and it is also used in the preparation of the site inspection at the time of product approval. All information contained in this report must be traceable to raw data and other reports, if applicable.
The format of the report is not critical, but the information must be present. A typical contents of analytical development report is mentioned below.
Content of the Analytical Development Report
1. Overview of project
- Statement of analytical testing
- Pertinent background information on test article (summary of synthetic scheme for substance, composition/ manufacturing process for dosage form).
2. Summary
- Summary of drug chemistry of substance
- Discussion of potential impurities and degradation products
- Degradation mechanisms and relevance
- Preformulation data summary
3. Method history
- Development history for key methods
- Discussion of method changes, additions, deletions
- Rationale for key methods
- Reference method development/validation reports
4. Specifications
- Rationale for proposed marketed product specifications
- History of specification setting, tightening, etc.
- Tables of key batches clearly illustrating justification for proposed specification
5. Stability
- Summary of stability behavior, trends, etc. for substance and/or product
- Reference substance or dosage form stability reports
- Brief discussion of “probe stability” studies as development pharmaceutics
6. Recommendations
- Guidance for quality unit laboratories
- Summary of key ingredients of each method
- Safety issues/precautions
- Use of compendial methods
7. References
- List of important reports/ sections
- “Partner” reports (chemical development, pharmaceutics, etc.)
The analytical development report is one of the most valuable documents written by the R&D unit during the development phase. If properly composed and completed, it can serve as a powerful document for many years after product approval.
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