Author: Pharma Editor

OBJECTIVE To lay down the procedure for Calibration of Tap density apparatus, Make – Electro lab. SCOPE This SOP shall provide the Calibration procedure of Tap density apparatus of quality control department. RESPONSIBILITY Officer/ Executive – Quality Control ACCOUNTABILITY Head QC/QA PROCEDURE Before starting the operation check for the area cleanliness and instrument cleanliness. Connect…

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OBJECTIVE To lay down the procedure for operation and calibration of Fourier Transform Infrared Spectrophotometer (Shimadzu) SCOPE This SOP shall be applicable for Quality Control in Quality Assurance department. RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Head Quality Control. PROCEDURE FOR CLEANING Check that the power supply to the instrument is switched ‘ OFF ‘ before cleaning….

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Procedure for calibration of conductivity meter (PICO) OBJECTIVE To lay down the procedure for calibration of pH / CONDUCTIVITY METER (PICO) SCOPE This Standard Operating Procedure (SOP) is applicable for pH meter (PICO).  RESPONSIBILITY Quality Control Executive / Officer. ACCOUNTABILITY Quality Control   Manager PROCEDURE Operate the Instrument as per procedure no.   BA(II)QA217 Calibrate the instrument…

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OBJECTIVE To lay down the procedure for CALIBRATION of KARL FISCHER (METTLER TOLEDO) SCOPE To ensure that the instrument performs satisfactory and gives accurate and reproducible data. This SOP shall be applicable for the KARL FISCHER APPARATUS (METTLER TOLEDO). RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Quality Control Manager. PROCEDURE FOR CLEANING Check that the power supply…

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OBJECTIVE To lay down a procedure for Calibration of Friability Test Apparatus to give accurate and reproducible data. SCOPE This Standard Operating Procedure (SOP) is applicable to In process samples. RESPONSIBILITY IPQA / Production Executive / Officer  ACCOUNTABILITY Head–Quality Assurance PROCEDURE Operate the Friability test apparatus as per SOP No.  BA(II)QA202 Set display to 30…

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OBJECTIVE To lay down a procedure for Calibration of Disintegration test apparatus SCOPE This Standard Operating Procedure (SOP) is applicable to DT apparatus placed in IPQC lab and in Quality Control. RESPONSIBILITY IPQA / Production Executive / Officer  ACCOUNTABILITY Head–Quality Assurance PROCEDURE Check the water level in the water bath. Fill the water in the…

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OBJECTIVE To lay down a procedure for Operation of weighing balance PB-303S. SCOPE This Standard Operating Procedure (SOP) shall be applicable for weighing balances installed in sampling booth. RESPONSIBILITYQuality Control Officer / Executive ACCOUNTABILITY Head – Quality Assurance\ PROCEDURE On/off switching Press < IB> key briefly. The balance performs a display test (all segments in…

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OBJECTIVE To lay down the procedure for operation of pH / Conductivity meter (PICO) SCOPE To ensure that the instrument performs satisfactory and gives accurate and reproducible data. This SOP shall be applicable for the pH / Conductivity meter (PICO). RESPONSIBILITY Quality Control Executive/Officer ACCOUNTABILITY Quality Control Manager. PROCEDURE PROCEDURE FOR CLEANING Check that the…

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OBJECTIVE To lay down the procedure for Operation of Milli Q water system, Make Millipore. SCOPE  This SOP shall provide the Operating procedure of Milli – Q water system of quality control department. RESPONSIBILITY  Officer/ Executive – Quality Control ACCOUNTABILITY Head QC/QA PROCEDURE OPERATION OF ELIX –10 Switch on Elix – 10 power supply button…

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OBJECTIVE To lay down a procedure for operation of SAS SUPER 100 Air sampler. SCOPE This SOP shall be applicable for viable air monitoring. RESPONSIBILITY Microbiologist ACCOUNTABILITY Head QC/QA PROCEDURE PRE START UP Remove the aspirating head. Insert an identified, closed contact plate and remove the lid of the plate. Replace the aspirating head. Operate…

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Humidity chamber The purpose of humidity chambers is to test the influence of varying environments on products to determine the length of their usefulness and at what point they will fail. The collected data assists engineers in adjusting their designs and selecting more resilient materials. Humidity chambers play a crucial role in various industries, aiding…

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Operating procedure for ultrasonic bath. Quality assurance OBJECTIVE To lay down a procedure for operation and cleaning of ultra sonic bath SCOPE This SOP shall be applicable for operation and cleaning of Ultra sonic bath. RESPONSIBILITY Quality Control Executive/Officer ACCOUNTABILITY Head-Quality Control. PROCEDURE  FOR CLEANING Switch OFF the equipment and drain out the water from…

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Calibration procedure for gas chromatograph clarus 500 with headspace (Perkin Elmer) OBJECTIVE To lay down the procedure for calibration of  GC  Clarus 500 with headspace (Perkin Elmer ) SCOPE This SOP shall be applicable for the GC Clarus 500 with headspace (Perkin Elmer). RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Head Quality Control. CALIBRATION PARAMETERS Oven temperature…

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Area clearance during batch/product change over in Pilot Production facility. Quality Assurance OBJECTIVE : To provide procedure for  Area  clearance during batch/product change over in Pilot Production facility. RESPONSIBILITY : Officer Quality Assurance  for implementation Quality Assurance Manager to ensure compliance. PROCEDURE : Note: (i)  Type-A  Area clearance : During batch change over of same…

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Preparation, Approval and Control of Guidelines (Quality Assurance) OBJECTIVE : To lay down the procedure for the preparation, approval and control of Guidelines. RESPONSIBILITY : All the personnel shall to be familiar with this SOP. The approver to ensure that all proposed Guidelines conform to this SOP before approving any Guidelines. PROCEDURE : Definition of…

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