This category includes Quality Related SOP’s, i.e. Quality Assurance & Quality Control departments
Standard operating Procedure & Protocol for Cleaning Validation to prove that the equipment cleaning procedure can repeatedly and reproducibly remove residue of the previous product below established acceptance limit. The acceptance limit is maximum allowable quantity of product residue, which does not affect quality and safety of the subsequent product to be manufactured, by using same equipment and facility. Cleaning…
Standard Operating Procedure for performing analytical method verification of compendial procedure/ validated analytical methods in quality control department. Describes characteristics for analytical method verification to be carried out for drug substances and drug products. Analytical Method Verification 1.0 Objective : To lay down the procedure for performance of analytical method verification of compendial procedure/validated analytical methods in quality control department.…
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…
Procedure for Isolation and Identification of Microbial Cultures & Microbial Isolates using different Analytical Methods from the manufacturing environment of OSD, oral liquid, sampling & Dispensing area, Microbiology section and water isolates from water system, colony isolated from MLT positive results and Standard Microbial cultures. Isolation and Identification of Microbial Cultures & Microbial Isolates 1.0 Objective : To lay down…
Standard Operating Procedure (SOP) for Failure Investigation (process failure as well as non-process failure) occurs during manufacturing or processing of drug products. Failure Investigation 1.0 Objective : To lay down the procedure for failure investigation of any activity to meet its predetermined specification, limits or acceptance criteria. 2.0 Scope : This SOP is applicable to process failure as well as…
This SOP describes the process and requirements for the transfer of analytical test method from an originating laboratory (Transferring Unit) to a receiving laboratory (Receiving Unit). This SOP provides the requirements for the transfer of validated analytical methods. It defines a process for preparing for transfer, executing transfer testing and preparing final reports. Analytical Method Transfer 1.0 PURPOSE: This SOP…
Standard Operating Procedure for Microbiological Analysis of Water used for manufacturing of various drug product in pharmaceutical industry. Procedure for Microbiological Analysis of Water 1.0 Objective : To lay down a Procedure for microbiological analysis of Water. 2.0 Scope : This SOP is applicable in Microbiology for microbiological analysis of water. 3.0 Procedure - Microbiological Analysis of Water: Microbiologist shall…
Guideline and Formats for Microbiological Environmental Monitoring (EM) of various area like in Production, Microbiology laboratory, Dispensing & Sampling Area, and Manufacturing Area etc. Microbiological Environmental Monitoring (EM) 1.0 Objective : To lay down a procedure for microbiological of environmental monitoring. 2.0 Scope : This SOP is applicable for microbiological environmental monitoring of area in Production, Microbiology laboratory, Dispensing &…
Standard operating Procedure for Subculturing (Cell Passaging) in microbiology and its maintenance. Subculturing also referred to as passaging cells, is the removal of the medium and transfer of cells from a previous culture into fresh growth medium, a procedure that enables the further propagation of the cell line or cell strain. Subculturing (Cell Passaging) 1.0 Objective : To lay down…
Standard Operating Procedure (SOP) for Microbiological Media Preparation. Media are required for cultivating the Micro-Organism. Microbiology Media should be prepared in proper way with adjusting proper pH required for growth of Micro-Organism. Preparation of Microbiology Media 1.0 Objective : To lay down a procedure for preparation of media for microbiological tests. 2.0 Scope : This SOP is for preparation of…
The Microbial limit test (MLT) is performed to assess how many and which of certain viable microorganisms are present in non-sterile pharmaceutical, healthcare or cosmetics manufacturing samples that range from raw materials to finished products. Microbial limit test (MLT) 1.0 Objective : To lay down a procedure for microbial limit test (MLT). 2.0 Scope : This SOP is applicable in…
Standard Operating Procedure for Cleaning and Operation of Vibro Sifter. Pharmaceutical Vibro Sifter is used to separate mass composition of solids, liquid from solid and grading the material as per particles size. It is a type of pharmaceutical machine used for separation of pharmaceutical solids or liquids. Vibro Sifter - Operation & Cleaning 1.0 Objective To lay down the procedure for cleaning & operation 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…
Standard Operation Procedure (SOP) of providing training and qualification of analyst for all new appointed personnel, and existing employees who are responsible for sampling & testing of incoming materials, in process samples and finished products. Analyst Qualification Procedure 1.0 Objective : To lay down a procedure of providing training and qualification of analyst for all new appointed personnel, and existing…
Guideline for Laboratory Standard Management (Preparation, Qualification and Handling of Analytical standards/Working Standard/Primary Standard etc.) Working Standard Management 1.0 Objective : To lay down a procedure for the Preparation, Qualification and Handling of Analytical standards (Working Standard, Reference Standard & Primary Standards). 2.0 Scope : This SOP is applicable in Quality Control for the Preparation, Qualification and Handling of Analytical…
Standard Operating Procedure (SOP) and Guideline for sampling of raw material (API and Excipient) / Starting material for analysis. Raw Material Sampling Procedure 1.0 Objective : To lay down a procedure for sampling of raw materials. 2.0 Scope : This SOP is applicable for sampling of raw materials at pharmaceutical drug manufacturing plant. 3.0 Procedure :…
