QA & QC

SOP on Monitoring of Temperature, Relative Humidity and Pressure Differential

SOP on Monitoring of Temperature, Relative Humidity and Pressure Differential Objective:  To lay down a procedure for monitoring temperature, relative humidity and differential pressure in controlled areas. Scope:  This SOP is applicable for monitoring and recording the temperature (°C), Relative humidity (%) and differential pressure (Pa) in controlled areas using …

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SOP on Technology Transfer for Analytical Method

SOP on Technology Transfer for Analytical Method Objective: To lay down the procedure for Transfer of Technology for Analytical Methods. Scope: This procedure is applicable for Transfer of technology for Analytical Methods from ARD to Pharmaceutical Plant. Responsibility: Responsibility of Sending Unit (ARD ) are : Preparation of Technology transfer …

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SOP on Transfer of Technology for Manufacturing process

SOP on Transfer of Technology for Manufacturing process Objective: To lay down the procedure for Transfer of Technology for Manufacturing Process. Scope: This procedure is applicable for Transfer of technology (i.e. for Manufacturing process) from sending unit ( R&D) to receiving site (Manufacturing facility ) Responsibility: Responsibility of Sending Unit …

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SOP on Execution of Exhibit Batches

SOP on Execution of Exhibit Batches  Objective To lay down a procedure for execution of exhibit batches. Scope This SOP is applicable for execution of exhibit batches to formulation plant of Pharma Company. Responsibility Officer/above of production and quality assurance department shall be responsible. Accountability Head of Department shall be …

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SOP For QUALITY BY DESIGN (QBD) IN PHAARMACEUTICAL PRODUCT

SOP For QUALITY BY DESIGN (QBD) IN PHAARMACEUTICAL PRODUCT INTRODUCTION: The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. Quality by Design (QbD) is emerging …

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How to face Interview

How to face Interview Remember, you never get a second chance to make a good first impression. However, good preparation takes the pain out of the process. Interview Preparation Remember: Prepare, prepare, prepare! Preparation is essential and greatly enhances your chances of performing well, So: know your CV know your …

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SOP for Sampling of In-process blends, uncoated tablets, coated tablets and filled capsules

SOP for Sampling of In-process blends, uncoated tablets, coated tablets and filled capsules OBJECTIVE : To provide procedure for representative sampling of  In-process blends, uncoated tablets, coated tablets and filled capsules. RESPONSIBILITY : Officer – Quality Assurance. Head – Quality Assurance to ensure compliance. PROCEDURE : After receiving the “Inprocess …

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SOP on Training

SOP on Training Objective: To lay down a procedure to conduct training of working personnel at all levels and its evaluation. Scope: This Standard Operating Procedure is applicable for training of personnel at Pharmaceuticals Company. Responsibility Head, QA or his/her designee for co-ordination on training of the personnel. Head of every department …

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SOP on Drug Product Recalls

SOP on Drug Product Recalls OBJECTIVE : To define the procedures used to effect the recall of a marketed product once it has been decided that such a course of action is required. RESPONSIBILITY : The  Managing  Director  and  Divisional  Head  shall be responsible for making the  decision  that  a  …

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