SOPs for Quality Control

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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