Learn about the essential steps for microbial monitoring of drain point in the pharmaceutical industry. Ensure compliance and safety with our detailed procedures. Gain insights into the importance of microbial monitoring at drain points in the pharmaceutical sector. Enhance product safety and mitigate contamination risks effectively. Microbiological Monitoring of Drain Points 1.0   Purpose To lay […]

Compressed air validation is recorded evidence that such parameters as aerosol particle content, dew point, liquid water concentration, vapor content, oil aerosols, and other pollutants are within limits and do not cause product contamination. Validation of Compressed Air 1.0   Objective The purpose of this protocol is to provide the procedure for the Validation of compressed […]

In microbiology labs, a biological safety cabinet (BSC) is an essential part of the apparatus. Experts can safely handle harmful biological agents and carry out procedures that safeguard the person conducting the study and the surrounding environment within its ventilated, enclosed workplace. The biological safety cabinet protects against product, personnel, and cross-contamination by using directional airflow […]

d Standard Operating Procedure (SOP) for Bacterial Endotoxin (LAL) Test in microbiology for pharmaceutical and healthcare laboratories and food industry. With our comprehensive Bacterial Endotoxin (LAL) Test Procedure, you may expedite your testing process and ensure consistent, dependable results. Procedure for Bacterial Endotoxin (LAL) Test 1.0   Purpose  The objective of this SOP is to lay […]

The production of pharmaceuticals depends on water. Quality Monitoring the of both raw and portable water is crucial at every stage to guarantee patient safety. Scientists utilize sophisticated equipment to screen for chemical and microbiological pollutants, just like detectives follow hints. They are aware that even minute contaminants can change a medication’s purity and efficacy. […]

Reverse Laminar Air Flow (RLAF) Booths, or sampling and dispensing booths, are another name for them. The product, operator, and environment are all intended to have a mixed air flow stream within the sample and dispensing booth. Since the dust particles that are released have numerous harmful effects, it is necessary to control their outflow. […]

The pharmaceutical industry is a vital sector that produces life-saving drugs and medical devices. However, the industry is not immune to human error, which can lead to costly consequences. Human error can occur at any stage of the pharmaceutical manufacturing process, from research and development to packaging and distribution. This article will discuss the causes […]

Data integrity is a fundamental pillar in the field of pharmaceuticals, playing a crucial role in maintaining the quality and safety of medicinal products. In an industry where human lives are at stake, the accuracy and reliability of data are of utmost importance. Therefore, it is imperative for pharmaceutical companies to establish robust systems and […]

Pharmaceutical contract manufacturing refers to the practice of contracting out the production of pharmaceuticals, such as pills, tablets, and capsules, for a third party to consume. Contract Manufacturing (CMO) Management Purpose The purpose of this standard operating procedure is to describe the procedure for Management of Contract Manufacturing service provided by contract Manufacturing Company, which […]

Standard operating procedure (SOP) to prepare the Reagent Solution for chemical analysis in the quality control laboratory General Reagent Solution Preparation 1.0   Objective To lay down the procedure for the preparation of the general reagent solution. 2.0   Scope This SOP is applicable in the Analytical / Quality Control Laboratory for the preparation of reagent solutions 3.0  […]

WFIWhat is a Quality Manual (Quality System Manual / QMS Manual? A Quality Manual is a document that was first required by the ISO 9001 standard for Quality Management Systems. A Quality Manual is a top-level document that describes an organization’s Quality Management System (QMS).  It can be used both internally (for employees) and externally […]

oProcedure and protocol for Dry heat sterilizer (DHS) validation, DHS consists of accurately measuring the temp. at critical points within the sterilization chamber throughout the process. Dry heat process generally employs a temperature between 250°C and 400°C for varying time. The sterilizer is required to heat all parts of its load up to the specified […]

uidance is provided on general procedure applicable for operation and calibration of High Performance Liquid Chromatography (HPLC) taking Agilent HPLC Infinity Series (Quaternary Channel) system as an example. Parameters to be considered for calibration of Agilent HPLC. Agilent HPLC – Operation & Calibration Procedure  1.0   Purpose The purpose of this SOP is to describe the […]

The MLT method must be validated before it will be applied when testing a product for resistance to bacteria in order to ensure that the product has no microbial inhibitory characteristics that could lead to false negative results. The MLT Method Suitability Test is known as the title of this validation test. Validation Protocol for MLT […]

The Antimicrobial Efficacy Test, also known as the preservative effectiveness test, is a compendial test performed during formulation development and stability testing of a parenteral drug product intended as a multi-dose product. Procedure for Antimicrobial Efficacy Test 1.0   Purpose: The purpose of this SOP is to check the efficacy of antimicrobial efficacy Test.  2.0   Scope: […]