COMPLIANCE REPORT FOR LACK OF INDEPENDENCE QUALITY ASSURANCE (QA) DEPARTMENT
During the WHO GMP inspection of a pharmaceutical plant, Name AABBCC, an observation was made that the Quality…
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QA
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HOLD TIME STUDY PROTOCOL CUM REPORT FOR ACECLOFENAC PARACETAMOL & SERRATIOPEPTIDASE TABLETS
The established time period for which dispensed raw materials, intermediates (in-process materials) and bulk…
INVESTIGATION REPORT FOR HIGH POWDER ACCUMULATION IN THE SCRUBBER OF THE COATING AREA
During routine observation in the coating area, it was noticed that the scrubber unit of the tablet coating…
INVESTIGATION REPORT FOR WRONG PRODUCT DESCRIPTION RECORDED IN THE BATCH PACKING RECORD
On 05/08/25 during routine review prior to dispatch, QA personnel observed a discrepancy in the product…
INVESTIGATION REPORT FOR THE OBSERVATION OF RUBBER PIECES IN GRANULES AFTER BLENDING STAGE
On 01/08/25, during the post-blending inspection of the Pantoprazole 40 mg batch PGH/T/25-012, multiple small…
INVESTIGATION REPORT FOR THE USE OF UNRELEASED RAW MATERIAL DURING THE MANUFACTURING
During routine in-process verification on 10/07/25, it was observed that an unreleased raw material was used…
INVESTIGATION REPORT FOR WRONG MANUFACTURING DATE MENTIONED ON MONO CARTONS
During routine in-process packaging inspection on 30/07/2025, it was observed that 20 mono cartons (out of 5000)…
INVESTIGATION REPORT FOR DISSOLUTION FAILURE IN TAMSULOSIN 4 MG PELLETS (PHASE 2)
The QC department reported a dissolution failure for Tamsulosin 4 mg pellets (Batch PGH/T/25-002), where the…
INVESTIGATION REPORT FOR HARDNESS FAILURE DURING IN-PROCESS CHECK AT COMPRESSION STAGE IN AMLODIPINE 10 MG TABLETS
On 21/07/25, during routine in-process quality checks conducted at the compression stage of Amlodipine Tablet 10…
INVESTIGATION REPORT FOR ASSAY FAILURE OBSERVATION DURING TESTING OF AMLODIPINE 10 MG TABLETS
Product Name: Amlodipine 10 mg Tablet
The product is manufactured by direct compression involving the following…