Pharma Devils - Risk Assessment | SOP | Cleaning Validation |

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Packing SOP

Standard Operating Procedure

PACKING SOP

March 6, 2026 March 6, 2026

PICTORIAL

DECODING AMPOULES

February 23, 2026 February 23, 2026

USING BENZYL ALCOHOL AS PRESERVATIVES IN INJECTABLE VIALS

PICTORIAL

USING BENZYL ALCOHOL AS PRESERVATIVES IN INJECTABLE VIALS (PICTORIAL)

December 13, 2025 December 13, 2025

Entry in Aseptic Area

PICTORIAL

ENTRY INTO ASEPTIC AREA [PICTORIAL]

November 30, 2025 December 7, 2025

Operational Qualification of Vibro Sifter

PICTORIAL

OPERATIONAL QUALIFICATION FOR VIBRO SIFTER [PICTORIAL]

November 30, 2025 December 7, 2025

Installation Qualification of Vibro Sifter

PICTORIAL

INSTALLATION QUALIFICATION FOR VIBRO SIFTER [PICTORIAL]

November 29, 2025 December 7, 2025

Disinfectant Validation in Pharma

PICTORIAL

DISINFECTANT EFFICACY VALIDATION [PICTORIAL]

November 23, 2025 December 7, 2025

Fogging in Pharma

PICTORIAL

FOGGING IN PHARMA [PICTORIAL]

November 22, 2025 December 7, 2025

Daily Balance Verification

PICTORIAL

DAILY BALANCE VERIFICATION [PICTORIAL]

November 16, 2025 December 7, 2025

Decartoning of Ampoules

PICTORIAL

DECARTONING OF AMPOULES [PICTORIAL]

November 14, 2025 December 7, 2025

Personal Monitoring

PICTORIAL

PERSONAL QUALIFICATION IN PHARMA [PICTORIAL]

November 8, 2025 December 7, 2025

Operation of Compression Machine

PICTORIAL

OPERATION OF COMPRESSION MACHINE IN PHARMA [PICTORIAL]

November 3, 2025 December 7, 2025

Solvent Dispensing Area

PICTORIAL

DECODING SOLVENT DISPENSING AREA IN PHARMA (PICTORIAL)

October 31, 2025 December 7, 2025

ENTRY PROCEDURE IN MANUFACTURING CORRIDOR

PICTORIAL

ENTRY PROCEDURE IN MANUFACTURING CORRIDOR [PICTORIAL]

October 30, 2025 December 7, 2025

Operation of Vibro Sifter

PICTORIAL

OPERATION OF VIBRO SIFTER (PICTORIAL)

October 27, 2025 December 7, 2025

RM Dispensing in Pharma

PICTORIAL

RM DISPENSING IN PHARMA (PICTORIAL)

October 26, 2025 December 7, 2025

DECODING DIETHYL ALCOHOL (DEG) & ETHYL ALCOHOL (EG) NOTIFICATION (FOR ORAL LIQUIDS)

PICTORIAL

DECODING DIETHYL ALCOHOL (DEG) & ETHYL ALCOHOL (EG) NOTIFICATION (FOR ORAL LIQUIDS) (PICTORIAL)

October 24, 2025 December 7, 2025

PICTORIAL

DECODING BULGING PROBLEM IN TABLET STRIPS (PICTORIAL)

October 23, 2025 December 7, 2025

Staging Area

Documents

DECODING WAREHOUSE (CHAPTER 4 – STAGING AREA)

October 23, 2025 December 7, 2025

Quarantine Area

Documents

DECODING WAREHOUSE (CHAPTER 3 – QUARANTINE AREA)

October 22, 2025 December 4, 2025

Pharma plant and Premises

Documents

DECODING PHARMA PLANT & PREMISES (AS PER SCHEDULE M)

October 22, 2025 December 4, 2025

Risk Assessment for De-dusting Tunnel

Documents

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

October 21, 2025 December 4, 2025

De-Dusting Tunnel

Documents

DECODING WAREHOUSE (CHAPTER 1: DE-DUSTING TUNNEL)

October 20, 2025 December 4, 2025

Risk Assessment for Autoclave

Quality Risk Assessment

RISK ASSESSMENT FOR AUTOCLAVE

October 19, 2025 December 7, 2025

risk assessment-for-relocation of compression machine

Quality Risk Assessment

RISK ASSESSMENT FOR RELOCATION OF COMPRESSION MACHINE

August 13, 2025 December 7, 2025

Single Door Entry system

Quality Risk Assessment

RISK ASSESSMENT FOR SINGLE DOOR ENTRY IN MICROBIOLOGY LAB

August 7, 2025 December 7, 2025

Computer System Validation master plan

VALIDATION

CSV

July 31, 2025 February 23, 2026

Risk Assessment for Glass Particles observed in Ampoules

Quality Risk Assessment

Risk Assessment for Glass Particles observed in Ampoules

July 13, 2025 December 7, 2025

Risk Assessment for MRM not performed

Quality Risk Assessment

Risk Assessment for MRM not performed

July 13, 2025 December 7, 2025

Risk Assessment for Load Mapping Studies in Pharma

Quality Risk Assessment

Risk Assessment for Load Mapping Studies in Pharma

July 10, 2025 December 7, 2025

Risk Assessment for Electricity Failure in Pharma

Quality Risk Assessment

Risk Assessment for Electricity Failure in Pharma

July 7, 2025 December 7, 2025

Risk Assessment for using Expired Filter Bags

Quality Risk Assessment

Risk Assessment of using Expired Filter Bags

July 6, 2025 December 7, 2025

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

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

Risk Assessment for Batch Release before QC Release

Quality Risk Assessment

Risk Assessment for Batch Release before QC Release

July 4, 2025 December 7, 2025

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

Quality Risk Assessment

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

July 4, 2025 December 7, 2025

Risk Assessment for Guidelines not followed

Quality Risk Assessment

Risk Assessment for Guidelines not followed

July 4, 2025 December 7, 2025

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

Quality Risk Assessment

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

July 4, 2025 December 13, 2025

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

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

Risk Assessment for Cross-Contamination in Microbiology

Quality Risk Assessment

Risk Assessment for Cross Contamination in Microbiology

July 3, 2025 December 7, 2025

Risk Assessment for Mix-up of Different Product Blister

Quality Risk Assessment

Risk Assessment for Mix-up of Different Product Blister

July 3, 2025 December 7, 2025

Risk Assessment for White Fibres observed in Vial or Ampoules

Quality Risk Assessment

Risk Assessment for White Fibers observed in Vial or Ampoules

July 2, 2025 December 7, 2025

Risk Assessment for White Precipitates observed in Vial

Quality Risk Assessment

Risk Assessment for White Precipitates observed in Vial

July 2, 2025 December 7, 2025

Risk Assessment for Black Particles observed in Ampoules

Quality Risk Assessment

Risk Assessment for Black Particles observed in Ampoules

July 2, 2025 December 7, 2025

Risk Assessment for Not Hiring IT Personnel

Quality Risk Assessment

Risk Assessment for Not Hiring IT Personnel

June 30, 2025 December 7, 2025

Risk Assessment for Employees not following Hierarchy

Quality Risk Assessment

Risk Assessment for Employees not following Hierarchy

June 30, 2025 December 7, 2025

Workers Consuming Narcotics during duty time

Quality Risk Assessment

Risk Assessment for Workers Consuming Narcotics during Duty Time

June 30, 2025 December 7, 2025

Risk Assessment for Narcotic Drugs Consumption Not Updated

Quality Risk Assessment

Risk Assessment for Narcotic Drugs Consumption Not Updated

June 30, 2025 December 7, 2025

Risk Assessment on Management

Quality Risk Assessment

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

June 29, 2025 December 16, 2025

Risk Assessment of QMS Not Effective

Quality Risk Assessment

Risk Assessment of QMS Not Effective

June 29, 2025 December 7, 2025

Risk Assessment of API Calculation Not Verified

Quality Risk Assessment

Risk Assessment of API Calculation Not Verified

June 29, 2025 December 16, 2025

Risk Assessment for Visual Inspection not Performed

Quality Risk Assessment

Risk Assessment for Visual Inspection not Performed

June 29, 2025 December 7, 2025

Risk Assessment for Technology Transfer not Performed

Quality Risk Assessment

Risk Assessment for Technology Transfer not Performed

June 29, 2025 December 7, 2025

Risk Assessment for Spray Gun used in Coating

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

Risk Assessment for Persons not trained in ERP

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

Risk Assessment for Flow Property of Granules

Quality Risk Assessment

Risk Assessment for Flow Property of Granules

June 29, 2025 December 7, 2025

Risk Assessment for Culture Issues in Pharma

Quality Risk Assessment

Risk Assessment for Culture Issues in Pharma

June 29, 2025 December 7, 2025

Risk Assessment for Analytical Method Validation not Performed

Quality Risk Assessment

Risk Assessment for Analytical Method Validation not Performed

June 29, 2025 December 7, 2025

Risk Assessment for Analysis not performed for Excipients

Quality Risk Assessment

Risk Assessment for Analysis not performed for Excipients

June 29, 2025 December 7, 2025

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