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Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.

| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications Emcure Pharmaceuticals Limited |
15 May 2026 | Normal | Justification: Repeated failures indicate gaps in annual product reviews for trend analysis over complaint data. Excerpt: Failure to extend the investigations to other batches of (b) (4) that may have been associated with similar complaints. View Details |
| The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Bentley Laboratories LLC |
27 Mar 2026 | Normal | Justification: The APR highlights unapproved yield levels needing follow-up inquiries but were omitted. Excerpt: The APR states that the allowable theoretical yield for any given OTC drug product will be between. View Details |
| Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug product. Cosmetics & Cleaners International LLC |
26 Mar 2026 | Normal | Justification: Annual Product Quality Review is directly linked as it governs the periodic evaluation of critical product-related data and procedural compliance. Excerpt: Your firm's control procedure, SOP Q-08 "Annual Product Review"...are inadequate because they fail to include a review and assessment of the following: Complaints filed Recalls performed Returned or salvaged drug products Stability data Assessment of any failure to meet specifications Review of significant, unexplained discrepancies. View Details |
| Records are not maintained SO that data therein Dr. J Skinclinic, Inc |
23 Mar 2026 | Normal | Justification: The observation directly identifies the failure to conduct an Annual Product Review, a critical evaluation activity outlined in the SOP. Excerpt: Your firm's quality unit failed to follow your firm's SOP Number: SOP-128, SOP Title: Annual Product Review (APR). View Details |
| Your firm failed to conduct an annual product quality review of your API. Aurorium LLC |
06 Mar 2026 | Normal | Justification: The observation directly points to the failure in conducting the annual product quality review, impacting API compliance. Excerpt: Your firm failed to conduct an annual product quality review of your API. View Details |
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