Objective:To lay down a procedure for handling of Out of trend for stability sample Scope:This procedure shall be applicable for handling of out of trend of stability sample at quality control of pharmaceutical company name with location. Responsibility:QC personnel shall be responsible to follow the procedure as per SOP. Accountability:Department Head …
Read More »SOP on procurement and handling of working standards
SOP on procurement and handling of working standards Objective:To lay down a procedure for the procurement and handling of working standards. Scope:This SOP is applicable for procurement and handling of working standards in quality control laboratory of pharmaceutical company name with location. Responsibility:Chemist or above of QC laboratory shall be …
Read More »SOP on Procedure of volumetric solution preparation and standardization
SOP on Procedure of Volumetric solution preparation and standardization To lay down a procedure for preparation and standardization of volumetric solution. Scope Of SOP: This SOP is applicable for the preparation and standardization of volumetric solutions in a quality control laboratory in a pharmaceutical company name with location. Responsibility: An …
Read More »SOP on Procedure for sampling of raw material
Raw material SOP on Procedure for a sampling of raw material Objective: To lay down the procedure for sampling raw material. Scope: This procedure is applicable for a sampling of raw material in a Pharmaceutical company name with location. Responsibility: QC personnel shall be responsible for following the procedure mentioned …
Read More »SOP on calibration of glassware
Objective:To lay down the procedure for calibration of laboratory glassware. Scope:This SOP is applicable for calibration of laboratory glassware in Quality Control Department at pharmaceutical company name with location. Responsibility:Chemist or above of QA shall be responsible to follow the procedure mentioned in this SOP. Accountability:Department Head & QA Head …
Read More »USFDA GUIDElINES (Generic Drug )
180-Day Exclusivity When Multiple Abbreviated New Drug Applications Are Submitted on the Same Day (I) Abbreviated New Drug Applications: Impurities in Drug Products ANDAs: Impurities in Drug Substances; Chemistry, Manufacturing and Controls Information (I) ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing and Controls Information (I) ANDA Submissions …
Read More »Questions and Answers (USFDA)
Good Laboratory Practice Regulations — Questions and Answers (I) Bar Code Label Requirements – Questions and Answers ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers Pharma More Jobs and post Please click here
Read More »USFDA GUIDELINES(Current Good Manufacturing Practices/Compliance)
Current Good Manufacturing Practice for Phase 1 Investigational Drugs (I) Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production (I) Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography PET Drugs — Current Good Manufacturing Practice (CGMP) Pharmaceutical Components at Risk for Melamine …
Read More »USFDA Guideline (Chemistry, Manufacturing and Controls (CMC))
Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products Analytical Procedures and Methods Validation for Drugs and Biologics Changes to an Approved NDA or ANDA (Revised) (I) Changes to an Approved NDA or ANDA Questions and Answers (I) CMC Postapproval Manufacturing …
Read More »SOP on Calibration of Halogen Moisture Balance
Objective:To lay down the Calibration Procedure for Halogen Moisture Balance. Scope:This standard operating procedure is applicable for formulation plant of Pharmaceutical company name with location. Make: Mettler Toledo. Responsibility Trained worker / Operator shall be responsible for operating of the equipment as per this SOP. Production Supervisor / Officer shall …
Read More »SOP On Operation of Halogen Moisture Balance
Objective:To lay down the Operating procedure for Halogen Moisture Balance. Scope:This standard operating procedure shall be applicable for formulation plant of Pharmaceutical company name with location. Make: Mettler Toledo. Responsibility Trained worker / Operator shall be responsible for operating of the equipment as per this SOP. Production Supervisor / Officer …
Read More »SOP on Cleaning and Operating Procedure for Vernier Caliper
Objective :To lay down the procedure for Cleaning and Operation of Vernier Caliper. Scope:This standard operating procedure is applicable for formulation plant of Pharmaceutical company name with location. Make: Mitutoyo. Responsibility Trained worker / Operator shall be responsible for cleaning and operating the equipment as per this SOP. Production Supervisor …
Read More »Movement of Man and Materials in Production area
Objective:To lay down a procedure for Movement of Man and Materials in Production area. Scope:This standard operating procedure is applicable for formulation plant of Pharmaceutical Company name with location. Responsibility Trained worker / Operator shall be responsible for Movement of material in Production Area as per this SOP. Production Supervisor …
Read More »Calibration and Operating Procedure for pH Meter
Objective:To lay down procedure for Calibration and Operation of pH Meter. Scope:This standard operating procedure is applicable for formulation plant of Pharmaceutical company name with location. Make: Mettler Toledo. Responsibility Trained worker / Operator shall be responsible for performing the calibration and operation of the equipment as per this SOP. …
Read More »SOP on Handling of PLC System Failure
Objective:To lay down the procedure for Handling of PLC System Failure. Scope:This standard operating procedure is applicable for all PLC system’s installed in formulation plant of Pharmaceutical company name with location. Responsibility Production Supervisor / Officer shall be responsible for implementation of this SOP. Engineering personnel shall be responsible for …
Read More »Operating Procedure for Tablet Hardness Tester (Monsanto)
Objective :To lay down the Procedure for Operating of Tablet Hardness Tester (Monsanto). Scope:This Standard Operating Procedure is applicable for formulation plant of Pharmaceutical company name with location. Make: Monsanto. Responsibility Trained worker / Operator shall be responsible for operating of the equipment as per this SOP. Production Supervisor / …
Read More »Operating Procedure for Tablet Hardness Tester (Erweka)
Objective:To lay down the Operating procedure for Tablet Hardness Tester. Scope:This Standard Operating Procedure is applicable for formulation plant of Pharmaceutical company name with location. Make: Erweka. Responsibility Trained worker / Operator shall be responsible for operating of the equipment as per this SOP. Production Supervisor / Officer shall be …
Read More »Calibration Procedure for Tablet Hardness Tester (Inweka)
Objective :To lay down procedure for Calibration of Tablet Hardness Tester (Inweka). Scope:This standard operating procedure is applicable for formulation plant of Pharmaceutical company name with location. Make: Inweka. Responsibility Operator shall be responsible for calibration of the equipment as per this SOP. Production Supervisor / Officer shall be responsible …
Read More »SOP on Procedure for Leak Test
Objective: To lay down a procedure for Leak Test. Scope:This standard operating procedure is applicable for formulation plant of Pharmaceutical company name with location. Responsibility Production Supervisor / Officer shall be responsible for implementation of the procedure mentioned in this SOP. Head, Production shall be responsible for compliance of procedure as …
Read More »SOP on Control of Sieves and Screens
SOP on Control of Sieves and Screens Objective: To lay down a procedure for Control of Sieves and Screens of different Equipments. Scope: This Standard Operating Procedure is applicable for the formulation plant of pharmaceutical company name with location. Responsibility Production Supervisor / Officer shall be responsible for implementation of …
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