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Deviation Handling and Quality Risk Management As Per WHO

Deviation Handling and Quality Risk Management This  guidance Based on WHO recommended requirements, these documents provide further explanations with examples in order to facilitate implementation. Deviation handling Quality Risk Management was mainly designed to be used prospectively when manufacturing operations are defined and validated. The potential deviations are identified and …

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Procedure for operation of pH / CONDUCTIVITY METTLER (PICO)

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 …

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Operating procedure for milli Q water system

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 …

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Procedure for operation of SAS SUPER 100 AIR SAMPLER

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. …

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Procedure for operation of walk in humidity chamber (25ºC/60%RH)

OBJECTIVE To lay down the procedure for operation of Walk in Stability Chamber (25°C/60%RH).   Model   : NEC-2530 RS Serial No.  : SCOPE This SOP shall be applicable for the operation of Walk in Stability Chamber (25°C/60%RH). RESPONSIBILITY QA Officer / Executive ACCOUNTABILITY Assistant Manager Quality Assurance PROCEDURE Operation of …

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Operating procedure for ultrasonic bath. Quality assurance

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 …

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Calibration procedure for gas chromatograph clarus 500 with head space (Perkin Elmer)

Calibration procedure for gas chromatograph clarus 500 with head space (Perkin Elmer) OBJECTIVE To lay down the procedure for calibration of  GC  Clarus 500 with head space (Perkin Elmer ) SCOPE This SOP shall be applicable for the GC Clarus 500 with head space (Perkin Elmer). RESPONSIBILITY Quality Control Executive/Officer. …

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Area clearance during batch/product change over in Pilot Production facility. Quality Assurance

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 …

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Preparation, Approval and Control of Guidelines (Quality Assurance)

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 …

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Technology transfer

Technology transfer OBJECTIVE : To  lay down a procedure for technology transfer of New products . SCOPE : The scope of this SOP is to all the new Products for which Technology has been provided by outside party or from R&D. RESPONSIBILITY : Head of Production, QA Head, QC Head  …

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