"Type - III" of drug master file gives information about

Question

Question

This question was previously asked in

RRB Pharmacist Exam Paper 2019

Answer 1

Correct Answer: Packaging materials

Rationale:

The Drug Master File (DMF) is a submission to the FDA that provides confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
A DMF is intended to permit the holder to provide information to the FDA, or to another entity, without disclosing the information to those parties.
Type III of the DMF specifically pertains to information about packaging materials used for drug products. This includes information on the composition, testing, and quality of packaging materials to ensure they are safe and effective in protecting the drug substance.

Explanation of Other Options:

Drug substances

Rationale: Information about drug substances falls under Type II DMF. This type covers details related to the drug's active pharmaceutical ingredients (API), including their manufacturing, controls, and stability.

Personnel / Facilities

Rationale: Information about personnel or facilities is not typically covered under any specific DMF type since DMFs are more focused on materials, processes, and methods rather than personnel or facilities.

Excipients

Rationale: Information about drug product excipients is covered under Type IV DMF. This includes the inactive ingredients used in drug formulations, providing information on their safety, quality, and performance characteristics.

Conclusion:

Type III DMF provides detailed information about packaging materials. This ensures that the materials used in packaging drug products meet safety and quality standards necessary to protect the integrity of the drug substance.
Other types of DMFs, such as Type II and Type IV, cover information about drug substances and excipients, respectively, ensuring that each component of drug manufacturing and packaging is thoroughly validated and maintained under regulatory standards.