Standard Operating Procedure

PACKING SOP IN PHARMA

March 6, 2026 May 2, 2026

Documents

DECODING WAREHOUSE (CHAPTER 4 – STAGING AREA)

October 23, 2025 December 7, 2025

Documents

DECODING WAREHOUSE (CHAPTER 3 – QUARANTINE AREA)

October 22, 2025 December 4, 2025

Documents

DECODING PHARMA PLANT & PREMISES (AS PER SCHEDULE M)

October 22, 2025 December 4, 2025

Documents

DECODING WAREHOUSE (CHAPTER 2: RISK ASSESSMENT OF DE-DUSTING TUNNEL)

October 21, 2025 December 4, 2025

Documents

DECODING WAREHOUSE (CHAPTER 1: DE-DUSTING TUNNEL)

October 20, 2025 December 4, 2025

Quality Risk Assessment

RISK ASSESSMENT FOR AUTOCLAVE

October 19, 2025 December 7, 2025

Quality Risk Assessment

RISK ASSESSMENT FOR RELOCATION OF COMPRESSION MACHINE

August 13, 2025 December 7, 2025

Quality Risk Assessment

RISK ASSESSMENT FOR SINGLE DOOR ENTRY IN MICROBIOLOGY LAB

August 7, 2025 December 7, 2025

VALIDATION

CSV

July 31, 2025 February 23, 2026

Quality Risk Assessment

Risk Assessment for Glass Particles observed in Ampoules

July 13, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for MRM not performed

July 13, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Load Mapping Studies in Pharma

July 10, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Electricity Failure in Pharma

July 7, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment of using Expired Filter Bags

July 6, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for the Mix-up of printed hard gelatin capsules (with imprint) and Plain capsules (without imprint)

July 6, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Batch Release before QC Release

July 4, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Companies purchasing Dossiers without doing actual F & D

July 4, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Guidelines not followed

July 4, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Mint Flavour used instead of Mixed Fruit Flavour in Sildenafil Citrate Jelly

July 4, 2025 May 2, 2026

Quality Risk Assessment

Risk Assessment for too much interference of non technical management into technical issues of a Pharma Company

July 4, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Cross Contamination in Microbiology

July 3, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Mix-up of Different Product Blister

July 3, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for White Fibers observed in Vial or Ampoules

July 2, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for White Precipitates observed in Vial

July 2, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Black Particles observed in Ampoules

July 2, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Not Hiring IT Personnel

June 30, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Employees not following Hierarchy

June 30, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Workers Consuming Narcotics during Duty Time

June 30, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Narcotic Drugs Consumption Not Updated

June 30, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment on Management Not Taking Audits Seriously and Focusing Solely on Productivity

June 29, 2025 December 16, 2025

Quality Risk Assessment

Risk Assessment of QMS Not Effective

June 29, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment of API Calculation Not Verified

June 29, 2025 December 16, 2025

Quality Risk Assessment

Risk Assessment for Visual Inspection not Performed

June 29, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Technology Transfer not Performed

June 29, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Spray Gun used in Coating

June 29, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Shelf Life not evaluated on the Basis of Stability

June 29, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Persons not trained in Pharma ERP

June 29, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Media Fill not Performed

June 29, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Flow Property of Granules

June 29, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Culture Issues in Pharma

June 29, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Analytical Method Validation not Performed

June 29, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Analysis not performed for Excipients

June 29, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Line Clearance not performed

June 29, 2025 December 16, 2025

Quality Risk Assessment

Risk Assessment for Using Expired Dies and Punches

June 27, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Analysis not done for Primary Packing Material

June 27, 2025 December 16, 2025

Quality Risk Assessment

Risk Assessment of Using Aluminium tubes in Ointment

June 27, 2025 December 16, 2025

Quality Risk Assessment

Risk Assessment for Improper Gowning in Aseptic Area

June 26, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Light Sensitive Product

June 26, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Storage Conditions not maintained in Different Stages

June 26, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Improper SOP’s in Pharma

June 26, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for APQR

June 26, 2025 December 16, 2025

Quality Risk Assessment

Risk Assessment for Inefficient QA in Pharma

June 25, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Epoxy in Pharma

June 25, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for GMP Drains

June 25, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Low Illumination in Visual Inspection area

June 25, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Pressure Differential not maintained in Classified Areas

June 25, 2025 December 16, 2025

Quality Risk Assessment

Risk Assessment for Typo Error in Pharma

June 24, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Data Integrity

June 24, 2025 December 7, 2025

Quality Risk Assessment

Risk Assessment for Stability Samples not Charged

June 24, 2025 December 7, 2025