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SOP

SOP on the Transfer of Technology 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 Formulation Unit. Responsibility: Responsibility of Sending Unit (ARD ) are : Preparation of Technology transfer Protocol for Analytical Method transfer. Execution of …

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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 (F R&D) to receiving site (Manufacturing facility ) Responsibility: Responsibility of Sending Unit …

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SOP on Fogging of Microbiology Testing Areas

Objective: To lay down the procedure for Fogging of Microbiology Testing Areas Scope: This SOP is applicable for Fogging of Microbiology Testing Areas in Microbiology Laboratory. Responsibility: Chemist or above of Microbiology Laboratory: Head – Microbiology section. Accountability: Head – Quality Control. Procedure: Operation Perform the Fogging of Microbiology once …

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SOP on cleaning and operating procedure of bursting strength tester

Objective: To lay down the cleaning & operating procedure of bursting strength tester. Scope: This SOP is applicable for the cleaning & operating procedure of bursting strength tester in quality control laboratory. Responsibilities: Chemist or above of QC laboratory in Packaging material Quality Control section is responsible for carrying out …

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Handling of Microbiological Data Deviation in Microbiology Laboratory

Objective: To lay down the procedure for Handling of Microbiological Data Deviation in Microbiology Laboratory. Scope: This procedure is applicable to environmental monitoring excursions (namely Passive air sampling, Active air sampling, Surface sampling, Personnel monitoring, and Compressed gas monitoring)obtained during the Environmental monitoring, Sterility testing, Bacterial Endotoxin Test, Bioburden, Microbial …

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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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Correction of Documentation Errors

  Objective To lay down a procedure for correcting the errors in documentation. Scope This Standard Operating Procedure is applicable for correction of all documentation error in written procedures (SOPs, Specifications, STPs, or TDs etc.) and records (Batch Manufacturing Records, Raw Data, Log Books, etc.) Responsibility Each employee shall be …

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New Product Design and Development Process

  New Product Design and Development Process Objective To lay down a Procedure for New Product Design and Development Process. Scope This Standard Operating Procedure is applicable all pharmaceutical formulation plants. Responsibility Head, Clinical Research : Conducting Clinical Trials as per the Good Clinical Practices and review and compilation of …

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Approval of vendors (Packing Materials)

  OBJECTIVE: To lay down a procedure for approval of new vendors for packaging materials. SCOPE: This SOP is applicable to all new manufacturer / suppliers of packaging materials RESPONSIBILITY: Purchase, QC and QA personnel shall be responsible to follow the procedure mentioned in this SOP. ACCOUNTABILITY : QA Head …

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Vendor Development and Approval (API and excipients)

Vendor Development and Approval (API and excipients) OBJECTIVE : To lay down a procedure for vendor audit for raw material, developing and approving the vendor who can consistently supply the raw materials with right quality and quantity at right time. SCOPE : This Standard Operating Procedure is applicable to approve …

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