Standard Operating Procedure (SOP) and format/Protocol of HPLC system calibration as per newly released Indian Pharmacopoeia (IP) recommendations. This Procedure is applicable for Shimadzu make HPLC and UPLC Systems, Agilent make HPLC Systems, Thermo make UHPLC & UPLC, Waters make HPLC Systems etc. HPLC Calibration Parameters are - Flow rate accuracy - HPLC Pump Calibration Temperature accuracy of HPLC column…
Calibration Policy/SOP - Instrument calibration is one of the primary processes used to maintain instrument accuracy. Calibration is the process of configuring an instrument to provide a result for a sample within an acceptable range. Policy - Calibration of Instrument & Equipment 1.0 OBJECTIVE To define the policy for calibration of all master instruments and measuring devices used for measuring, monitoring…
Standard Operating Procedure for Operation and Calibration of Top Loading Balance used in the pharmaceutical industry, guideline, and formats of uses and calibration/qualification. Operation & Calibration Procedure for Top Loading Balance 1.0 Purpose : To lay down a procedure for Operation and Calibration of Top Loading Balance. 2.0 Scope : This SOP is applicable for Top Loading Balance used in…
Standard Operating Procedure (SOP) for Handling of Data Integrity Incident Investigation and compliance in Pharmaceutical Drug Manufacturing Plant. Handling of Data Integrity Incident 1.0 PURPOSE: To provide a procedure to investigate and handle data integrity incidences related to GXP data, identified during internal audit or during review of data. 2.0 SCOPE: Applicable to all GxP data generated by electronic and…
Standard Operating Procedure (SOP) for Handling Procedure of Instrument Calibration in Quality Control Laboratory. Calibration: The set of operations that establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by material measure and the corresponding values of the measured. Handling of Instrument Calibration 1.0 Objective To lay down a procedure…
Documents and Data Control is a function or department which keeps track of all documentation, specifications, and processes. The purpose is to ensure that everyone uses the correct and current document processes and specifications. Documents and Data Control 1.0 Objective To lay down a procedure for control of documents and documented data. 2.0 Scope This SOP is applicable for the…
Equipment Qualification is the final series of inspections and tests to ensure that critical requirements necessary for related product quality are satisfied and that documents and procedures necessary to properly operate and maintain the system are in place. Equipment Qualification Procedure 1.0 Objective : To lay down the procedure for preparation of Qualification documents, execution of Qualification activities, Review and…
Standard Operating Procedure (SOP) for Cleaning of Laboratory Glassware. Occasionally, more aggressive cleaning solutions may be necessary when laboratory glassware is extremely dirty. These solutions are often highly corrosive, involving concentrated acids or bases, and can cause injury. Cleaning of Laboratory Glassware 1.0 Objective : To lay down a procedure for cleaning of laboratory glassware. 2.0 Scope : This SOP…
Standard Operating Procedure (SOP) for Operation and Calibration of Brookfield make Viscometer used to determine the viscosity of solution / suspension / liquids in Quality Control department. Viscometer (Brookfield) - Operation and Calibration Procedure 1.0 Objective : To lay down a procedure for operation and calibration of viscometer. It is used to determine the viscosity of solution / suspension /…
Standard Operating Procedure (SOP) for Operation and calibration of Polarimeter used to determine of optical rotation of raw material in Quality Control. Procedure for Polarimeter - Operation and Calibration 1.0 Objective : To lay down a procedure for operating and calibration of Polarimeter. It is used to determine the optical rotation of material. 2.0 Scope : This SOP is applicable…
Standard Operating Procedure (SOP) for Operation and Calibration of UV-Visible Spectrophotometer used for Qualitative and Quantitative analysis of starting material (RM-API & Excipient), water analysis and drug product. UV-Visible Spectrophotometer 1.0 Objective : To lay down a procedure for operation and calibration of UV-Visible Spectrophotometer. It is used for qualitative & quantitative determination of substances. 2.0 Scope : This SOP…
Standard Operating Procedure (SOP) for Operation and Calibration of FTIR Spectrophotometer used for identification test of starting material (RM) and drug product. FTIR Spectrophotometer 1.0 Objective : To lay down a procedure operation of FTIR Spectrophotometer. 2.0 Scope : This SOP is applicable for operation of FTIR Spectrophotometer (Make-BRUKER) in Quality Control Laboratory. 3.0 Procedure - Operation & Calibration of…
Standard Operating Procedure (SOP) for Operation and Calibration of Melting Point Apparatus in Quality Control Laboratory. Melting Point Apparatus 1.0 Objective : To lay down a procedure operation and Calibration of Melting Point apparatus. 2.0 Scope : This SOP is applicable for operation and calibration of Melting point apparatus in Quality Control. 3.0 Procedure : Operation and Calibration of Melting…