In the pharmaceutical industry, Exhibit Batches are manufactured to demonstrate and validate that a drug product or API (Active Pharmaceutical Ingredient) can be consistently produced according to the approved specifications. These batches are crucial for regulatory approval and commercialization.
Purpose of Exhibit Batches
- Regulatory Submission: Exhibit batches are produced and tested as part of the New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Drug Master File (DMF) submission to regulatory authorities like the FDA, EMA, or DCGI.
- Process Validation: They help verify that the manufacturing process is robust, reproducible, and meets Good Manufacturing Practices (GMP).
- Stability Studies: These batches undergo stability testing to establish the product’s shelf life and storage conditions.
- Bioequivalence Studies: If required, exhibit batches may be used in bioequivalence (BE) studies for generic drug approvals.
- Technology Transfer: They are often the first batches produced at a commercial scale after transferring from R&D to manufacturing.
Key Characteristics
- Usually produced at a commercial scale (or a significant proportion of it).
- Manufactured under GMP conditions.
- Tested for critical quality attributes (CQAs) such as assay, dissolution, impurity levels, and uniformity.
- Typically, three consecutive batches are required for process validation.
Exhibit Batch Requirements by Regulatory Authorities
- USFDA: Requires submission of exhibit batch data for ANDA/NDA approvals.
- EMA (Europe): Needs exhibit batch data as part of the Marketing Authorization Application (MAA).
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