Abstract

ANNUAL PRODUCT QUALITY REVIEW (APQR) OF TOPIRAMATE TABLETS USP 200 MG

Manoj Kumar*, Ojas B. Patel, Neha S. Patel and Dr. Harsha U. Patel

ABSTRACT

APQR (Annual Product Quality Review) is a mandatory requirement of CGMP (Current Good Manufacturing Process) for pharmaceutical industries. APQR is “rolling quality review for all commercial products”. APQR is performed with objective of “verifying the consistency of the existing process”, “verifying the appropriateness of starting material and finished product specification” and “detection of product and process improvement, if any”. Annual Product Quality Review (APQR) of Topiramate tablets USP 200 mg has been done. Validation Status of manufacturing process, Details of Process Validation details of cleaning validation Qualification Status of relevant equipments and utilities, Raw and packing material were used in manufacturing of Topiramate tablets USP 200 mg reviewed and found satisfactory. Quality parameter trend for Active Pharmaceutical ingredients, In process quality parameter at manufacturing stage (Dry granulation stage, compression stage and Coating stage) Water Content, Assay, Total impurities, HFS Speed, VFS Speed, Roll Speed, Mill Speed, Roll pressure, Blend LOD, Speed of Compression Machine, Thickness, Hardness, Friability, Spray rate of coater, Average Weight, Weight gain, Disintegration Time and yield at Granulation, Compression and Coating stage were evaluated and found satisfactory. In process parameter at Finished stage (Dissolution, Assay, Uniformity of dosage form, Water Content, Total Impurities, Residual solvent, Sulfate and sulfamate Impurities were evaluated and found satisfactory. Details of Change Control, Details of batches on stability, Details of Deviations, Details of Market Complaints, Details of OOT/OOS, Details of Batch reprocessing, product recall, Returned Goods, Filed Alert Report were evaluated and found satisfactory, Based on review of Batch manufacturing data, Analytical details, Process validation details, Qualification details and other QMS documents. It is concluded that manufacturing process under control and it remains in validated status, No specific action is purposed .Current control shall be continued and shall be monitored.

Keywords: Topiramate, APQR, API, QMS, Market Complaints, OOS/OOT Deviations, Validation.