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SOPs for Quality Control in Pharmaceutical Industry



List of Standard Operating Procedure for Quality Control Laboratory

SOP for Labelling, Storage and Expiry Dating of prepared chemical reagents, test samples and water samples 

SOP for Gowning, Entry and Exit procedure for Quality Control Department

SOP for Accuracy check of analytical balances

SOP for Quality Control Equipment Log Book

SOP for Preparation Review and Approval of QC Specifications & Test Procedures

SOP for Storage use and current lot Checking of chemical reference substance in QC Lab

SOP for Handling and storage of controlled substances in the laboratory

SOP for Sampling of water for injection

SOP for Storage Handling and Stock Management of Laboratory chemicals and reagents 

SOP for Chemical Laboratory Safety Procedures

SOP for Procedure for vendor rating

SOP for Approval of suppliers for raw and packaging materials

SOP for Disposition of raw material 

SOP for Release of packaging material

SOP for Release (approval) of bulk & finished products

SOP for Retest procedure for Raw & Packaging Material 

SOP for Current lot Checking procedure for chemical reference substance/reference standard

SOP for Storage of retained sample

SOP for Disposal / destruction of test samples & expired retention sample

SOP for Assigning of Laboratory Control Number

SOP for Glassware procurement, handling, washing and drying in the Laboratory

SOP for Frequency and method of cleaning of QC Laboratories

SOP for Sampling of  rinse water and swab samples

SOP for Preparation, review and approval of QC Specification

SOP for Start-up and operation of Sampling Booth

SOP for Numbering and Cleaning of Sampling tools

SOP for Procedure for column washing of HPLC and GC

SOP for Handling of Out of Specification Result

SOP for Procedure for generation of certificate of analysis and control of template

SOP for Assessment of performance of individual Analysts

SOP for Analysis of  Purified Water

SOP for Sampling of Powders and Granules using Sampling Thief

SOP for Preparation, review and approval of Packaging Material Specification

SOP for Change of status from 'Quarantine' to 'Passed' 

SOP for Change of status from 'Quarantine' to 'Rejected' 

SOP for Receiving, Storage and Control of test samples in QC Laboratory

SOP for Control of Status label

SOP for Procedure for recovery efficiency determination for cleaning validation

SOP for Procedure for LOD & LOQ determination for cleaning validation

SOP for Qualification & Handling of working standards in quality control laboratories

SOP for Storage condition of raw materials

SOP for Sampling  of  Effluent Treatment Plant Water

SOP for Procedure for personnel entry into the sampling booth

SOP for Finished product test procedure

SOP for Preparation, Standardization & Handling of volumetric solution 

SOP for HPLC/GC/IC column performance test procedure

SOP for Procedure for chemical monitoring of compressed air

SOP for Handling of atypical data (OOT)

SOP for Sampling of Raw materials and packaging materials

SOP for Analytical Method Validation

SOP for Analytical Procedure using the HPLC system during chemical analysis

SOP for Analytical Method transfer

SOP for Procedure for documentation in analysis log book

SOP for Temperature and relative humidity monitoring in QC laboratory

SOP for Batch Numbering system of Raw materials 

SOP for Procedure for Out of Trend Monitoring Programme for stability study

SOP for Completeness and Correctness of Analytical Reports

SOP for Stability Testing

SOP for TLC Spot Detection by UV-Lamp

SOP for Handling of Out of stability storage conditions parameters for stability chamber

SOP for Disposal of test sample received for stability testing

SOP for Handling of spillage in Quality Control Laboratory

SOP for Preparation and Control of status label for QC Laboratory

SOP for Access Control, security policies and user management

SOP for Issuance, Maintenance & Disposal of HPLC/GC/IC column

SOP for Cleaning procedure of purified water storing container

SOP for Procedure for replacement of silica gel and molecular sieve

SOP for Procedure for Laboratory analyst validation

SOP for Procedure for annual inspection of retention samples

SOP for Analytical Data Review

SOP for Reconciliation of test sample of raw materials, packaging materials and bulk products

SOP for Analytical balance accuracy check

SOP for Laboratory data integrity

SOP for Good Chromatographic Practices

SOP for Calculation and Rounding Off Significant Figures in Quality Control Laboratory

SOP for Reporting Of Incidents In Quality Control Laboratory

SOP for Releasing Procedure of Materials Received From One unit to another unit.

SOP for Sampling Water for Laboratory Area Water system 

SOP for Calibration of Karl Fischer Apparatus

SOP for Calibration of pH Meter

SOP for Calibration of High Performance Liquid Chromatography

SOP for Calibration of Gas Chromatography

SOP for Electronic Data Backup, Archival And Restoration Procedure

SOP for Preparation Review & Approval of Finished product Specification

SOP for Procedure of Calibration Programme of Laboratory Equipment

SOP for Good Laboratory Practices

SOP for Procedure for column regeneration of HPLC

SOP for Control of calculation sheet, data sheet, Test Report Sheet / Book and ATR sheet used in QC and Microbiology laboratory

SOP for Preventive Maintenance of Laboratory equipment

SOP for Procedure for selection , Installation and periodic check of laboratory instruments

SOP for Temperature monitoring by chart recorder in Quality Control Laboratory

SOP for Preparation and control of analytical test record sheet

SOP for Procedure for QC reviewer Qualification

SOP for Handling of placebo in QC laboratory

SOP for Qualification procedure to authorize personnel for QC batch release

SOP for Time Synchronization of Quality Control Equipment/ Instrument

SOP for Maintenance and Review of Audit trail of Electronically generated data.

SOP for Stability Chamber Management

SOP for Procedure for Qualification of visual Inspector in Quality Control Laboratory.

SOP for Handling of Extraneous chromatographic Peak

SOP for Sampling, Testing and reporting of Bore-hole water sample as per US-EPA Guideline.

SOP for Excel Worksheet Validation


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