This category includes Microbiology SOP’s
Cleaning is a crucial step in the manufacturing of pharmaceutical products, and it is essential to validate that the equipment is cleaned thoroughly. In identifying products for cleaning validation, worst-case identification is essential as well. Identification of Worst Case in Cleaning Validation Cleaning validation for every product produced in the facility is not feasible. As a result, products are chosen…
A media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium, in place of the drug solution, to test whether the aseptic procedures are adequate to prevent contamination during actual drug production. Media Fill Validation / Aseptic Process Simulation 1.0 OBJECTIVE To lay down the procedure to challenge the aseptic techniques used for sterile…
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…
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…
Standard Operating Procedure (SOP) for Finished Drug Product (Finished Goods) Release for Sale and Distribution including the review of batch documents and checkpoints. Finished Drug Product (Finished Goods) Release 1.0 Objective : To lay down the Procedure for release of Finished Products for sale & distribution. 2.0 Scope : This procedure is applicable to all products manufactured at pharmaceutical drug…
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…
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…
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 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…
Standard Operating Procedure (SOP) and Guideline for Preservative Efficacy Test in Microbiology Laboratory for checking of effectiveness of preservatives added in the drug formulations. Procedure for Preservative Efficacy Test 1.0 Objective : To lay down a procedure for preservative efficacy test. 2.0 Scope : This guideline is applicable in Microbiology Laboratory for checking of effectiveness of preservatives added in the…
Standard Operating Procedure (SOP) for Growth Promotion Test (GPT) of Microbiological Media in Microbiology Laboratory. Growth Promotion Test (GPT) 1.0 Objective : To lay down a procedure for Growth Promotion Test (GPT) of culture media. 2.0 Scope : This SOP is applicable to check the effectiveness of all dehydrated media purchased in Microbiology Laboratory. 3.0 Procedure - Growth Promotion Test…
Standard Operating Procedure (SOP) for Handling of Out of Trend (OOT) results during Stability Study of Drug Product. Out of Trend (OOT) Result 1.0 OBJECTIVE : To lay down a procedure for handling of Out of Trend (OOT) encountered during analysis and during stability study of Drug Product. 2.0 SCOPE : This SOP is applicable to all the Out of…
Standard Operating Procedure & Guideline for Hold Time Study of Drug Product at different manufacturing stages like bulk granules/powder, blend, bulk liquids, core tablets, coated tablets, filled capsule, binder and coating solution etc. Hold Time Study Procedure 1.0 Objective : To lay down the procedure for conducting the hold time study of pharmaceutical products during manufacturing at every stage. 2.0 …
Standard Operating Procedure and Guideline for New Product Introduction in existing set of product list and equipment trail and Quality Risk Management at Pharmaceuticals Drug Manufacturing Plant. Guideline for Introduction of Product 1.0 Objective : To lay down the procedure for introduction of new product at the manufacturing location. 2.0 Scope : This guideline is applicable for Introduction of new…
Standard Operating Procedure (SOP) & Guideline for Quality Risk Management (QRM) i.e. risk identification, analysis, evaluation, reduction/ mitigation, communication and conclusion of risk in order to ensure the quality, safety, integrity and purity (SISPQ) of the drug product. Quality Risk Management (QRM) 1.0 Objective : To lay down the procedure for risk identification, analysis, evaluation, reduction/ mitigation, communication and conclusion…