Let’s explore Module 2 of the ANDA submission:
1. **Quality Overall Summary (QOS)**:
The Quality Overall Summary (QOS) is a critical section in Module 2 of the ANDA. It provides a comprehensive overview of the quality-related information for the generic drug product. The QOS serves as a summary of the entire technical data presented in the ANDA submission related to the drug’s quality, pharmaceutical characteristics, and manufacturing processes.
The QOS typically includes detailed information on the following aspects:
– Drug Substance Information: Details about the active pharmaceutical ingredient (API), its characterization, manufacturing process, and controls.
– Drug Product Information: Information about the final dosage form of the generic drug, including formulation, composition, manufacturing process, and controls.
– Control of Excipients: Details about the quality and control of the excipients used in the drug product formulation.
– Reference Listed Drug (RLD) Comparison: A comparison between the generic drug and the reference listed drug (RLD) in terms of pharmaceutical equivalence, ensuring that the generic drug matches the RLD in critical attributes.
– Control of Drug Substance and Drug Product: Information on quality control procedures, analytical methods, specifications, and stability studies to maintain the quality and purity of both the drug substance and the drug product.
– Container Closure System: Description of the packaging materials and container closure system used for the drug product, ensuring stability and integrity.
– Stability Studies: Data from stability studies conducted to assess the drug’s shelf life and storage conditions.
– Microbiological Attributes (if applicable): Information about microbiological testing, endotoxin levels, and preservative effectiveness.
– In-Process Controls and Manufacturing Process: Details about the manufacturing process, critical steps, control measures, and validation procedures to ensure consistency and reproducibility.
Applicants should use the QbR model when writing their QOSs. The QbR model assists applicants in developing their QOS by providing specific questions that, when answered, ensure that applicants submit adequate information for FDA review.
FDA has posted the QbR-QOS outlines designed for simple dosage form products (solution or immediate-release solid oral dosage forms) and for sterility assurance of products terminally sterilized by moist heat.
FDA has also developed example QOS summaries for controlled-release capsules and immediate-release tablets.
Additionally, FDA recommends that applicants refer to the QbR Frequently Asked Questions and the QbR for Sterility Assurance.
Failure to submit the QOS in text-based PDF and Microsoft Word files will result in a deficiency during the filing review conducted by FDA upon submission of the ANDA. FDA recommends against submitting a scanned PDF copy of the QOS.
