Checklist / Check points of Laboratory preliminary Investigation (OOS Phase I) for find out the root cause for out of specification (OOS) test results. Laboratory Investigation Check Points / Report OOS Number : OOS login Date : Name of Product : Batch No. : Market : Batch Size / Qty : Mfg. Date : Test : G.R. No. / A.R.…
Guideline for Handling of Out of Specification (OOS) results occurs during analysis of Raw Material and Pharmaceutical Drug Products (Different stages like - In-process, Bulk, Intermediate, Finished Product & Stability Study Samples) Handling Out of Specification (OOS) Results 1.0 Objective : To lay down the procedure for investigation of Out of Specification (OOS) result(s) that occurs during sample testing in…
Checklist for Assessment or Evaluation of Raw material vendor (manufacturer of supplier). The Successful evaluation of Vendor’s ability and capability in meeting the company’s quality system requirements in relation to the criteria established for the material being sourced. Checklist for Assessment or Evaluation of Vendor Vendor Assessment / Evaluation Questionnaire ( Manufacturer ) Name of the Material Questionnaire to…
Vendor Audit is an evaluation of vendor's manufacturing site, for product of interest(s), for the understanding and application of the cGMP. Successful evaluation of Vendor’s ability and capability in meeting the company’s quality system requirements in relation to the criteria established for the material being sourced. Vendor Audit and Qualification Guideline 1.0 Objective : To lay down a procedure for…
Standard Operating Procedure (SOP) for Management of Walk in and stand-alone Stability Chamber used for Stability Study and also to determine the self life of the drug product. Stability Chamber / Incubators Management 1.0 Objective : To lay down a procedure for Management of Walk in and stand-alone Stability Chamber. 2.0 Scope : This SOP is applicable for Management of…
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) and Guideline for Laboratory Safety, Handling of Laboratory incidents, Volatile materials, Corrosive Chemicals, Laboratory Glassware, Environmental Safety (Laboratory) etc. Procedure for Laboratory Safety 1.0 Objective : To lay down a procedure for maintaining the laboratory safety. 2.0 Scope : This SOP is applicable in Quality Control during working in laboratory for safety. 3.0 Procedure - Laboratory…
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…