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USFDA’s Q&A Quality (CMC) Related Controlled Correspondence for Generic Drugs

This questions and answers (Q&A) guidance provides FDA’s current thinking on quality-related scientific and regulatory topics that appear frequently in controlled correspondence submissions.


The Office of Pharmaceutical Quality (OPQ) reviews correspondence from generic drug manufacturers and the related industry or their representatives related to generic drug development (i.e., controlled correspondence submissions) requesting information regarding chemistry, manufacturing, and controls, as well as product quality microbiology for generic drugs.


These Q&A are intended to proactively respond to those scientific and regulatory topics that appear frequently in controlled correspondence addressed by OPQ, thereby allowing the industry to move forward with certain generic drug development activities without the need to submit controlled correspondence to FDA.


This Q&A Addresses questions related to the following

1. Bracketing/Matrixing

2. Container-Closure

3. Dissolution

4. Microbiology (Endotoxin)

5. Number of Batches

6. Orientation

7. Packaging

8. Scoring and Split Tablet Testing

9. Size and Shape of Generic Solid Oral Dosage Forms


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