As a regulatory professional following points of a drug master file should review:
Administrative Information:
Verify that the DMF contains complete administrative information, including the DMF number, holder/applicant details, and contact information.
Confirm that the DMF includes a table of contents outlining the sections and subsections of the submission.
Drug Substance Information:
Review the description of the drug substance, ensuring clarity and specificity regarding its composition, structure, and intended use.
Verify that the DMF provides information on the source materials, including their specifications, characterization, and control measures.
Assess the suitability of the proposed drug substance or product for its intended use, considering factors such as pharmacological activity, route of administration, and dosage form.
Manufacturing Process:
Evaluate the manufacturing process described in the DMF, including all critical steps, unit operations, and controls.
Ensure that the manufacturing process is well-defined, reproducible, and capable of consistently producing the drug substance or product of the desired quality.
Check for compliance with current Good Manufacturing Practices (cGMP) and relevant regulatory guidelines, including validation of critical process parameters and in-process controls.
Controls:
Review the specifications for the drug substance or product, including tests, methods, and acceptance criteria for identity, strength, purity, and quality.
Assess the adequacy of control measures for critical quality attributes, impurities, and degradation products.
Verify that the DMF includes analytical methods validated for their intended use, with appropriate specificity, sensitivity, accuracy, and precision.
Stability Data:
Examine the stability data provided in the DMF to support the proposed shelf-life of the drug substance or product.
Ensure that stability studies have been conducted according to regulatory requirements, including appropriate storage conditions, time points, and analytical methods.
Evaluate the stability results to determine the degradation pathways, trends, and the impact on product quality over time.
Conclusions, and recommendations of the DMF review:
Ensure that the review report is accurate, objective, and compliant with internal procedures and regulatory guidelines.
Submit the review report to relevant stakeholders, such as regulatory authorities or internal decision-makers, as appropriate, following established submission procedures.
Read also:
- Drug Master File (DMF) in Pharmaceutical Industry
- Frequently Asked Questions on DMF Filing
- Sameness Evaluation of a Generic Drug Formula
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