Objective:To lay down a procedure for the handling of Primary Standard. Scope:This Standard Operating Procedure is applicable to Quality Control Department followed at Pharmaceutical Company name with location. Responsibility:QC personnel shall be responsible to follow the procedure as per SOP. Accountability:Department Head & QA Head shall be accountable for implementation of …
Read More »Stability study of volumetric solution
Stability study of volumetric solution Volumetric solutions, called titrants, are meticulously formulated solutions whose concentrations are precisely determined. These are extremely important in quantitative analysis where measurement accuracy is of paramount importance. Prominent examples include standard solutions of acids, bases, and salts used in titrations. These solutions are meticulously prepared …
Read More »Good Laboratory Practices (GLP)
Good Laboratory practices (GLP) in quality control To define a procedure for Good Laboratory Practices (GLP). SCOPE This SOP is applicable for quality control department for procedures for Good Laboratory Practices. DEFINITION(S) & ABBREVIATION(S) DEFINITION(S) Good Laboratory Practices (GLP) is a quality system concerned with organizational process and conditions under …
Read More »SOP on Analyst Qualification in quality control
ANALYST QUALIFICATION PURPOSE of ANALYST QUALIFICATION: To lay down the procedure for the qualification of analyst in order to confirm that the newly Joined employee analyst and analyst performing tests in quality control laboratory are adequately qualified to produce reliable and accurate results. SOP SCOPE ANALYST QUALIFICATION: This SOP applicable …
Read More »SOP on handling of Out of trend (OOT)
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 / …
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