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Pharmaceuticals Industrial revolution
Documentation in pharmaceuticals, good documentation practices in pharmaceuticals, Documentation and Records
Deionized (DI) water is a form of purified water with most or all of its mineral ions removed, such as cations like sodium, calcium, iron, and copper, and anions like chloride and sulfate. The pH level of deionized water is a critical parameter, especially in high-purity applications, but it presents unique challenges due to its … Read more
Ensure compliance with cGMP guidelines and user requirements with our comprehensive design qualifications protocol for Rapid Mixer Granulator. This detailed document covers material construction, surface finish, design parameters, control and automation features, and essential safety measures. Perfect for guaranteeing high-quality powder and granules processing equipment Objective The purpose of this document is to design, engineer, … Read more
Performance Qualification Protocol for Purified Water Generation & Distribution System (Phase-1), This Performance Qualification Protocol (Phase-1) for the Purified Water Generation & Distribution System in a pharmaceutical plant outlines the comprehensive procedures, responsibilities, and methodologies required to ensure the system consistently produces purified water meeting specified quality standards. The document details the scope, pre-qualification requirements, … Read more
Fault Tree Analysis (FTA) is a deductive failure analysis technique used to identify and analyze factors that can lead to a specific undesirable event (referred to as the “top event”). Originally developed for the aerospace industry in the 1960s, FTA has since been adapted for use in various fields, including pharmaceuticals. In the context of … Read more
Deviation Management will navigate with excellence & precision. Explore a systematic approach to address unexpected events, ensuring product and process excellence. Learn how identification, root cause analysis, and strategic actions minimize adverse effects, fostering continuous improvement. Elevate product quality, enhance compliance, and streamline operations with this indispensable tool in the world of quality assurance.” What … Read more
The best method for removing microorganisms from borewell water in pharmaceutical plants is often a multi-stage approach, incorporating various technologies to ensure thorough disinfection. One effective method is the use of Ultraviolet (UV) irradiation, coupled with an appropriate UV dose. Here’s how it works: UV Irradiation with UV Dose: Pros of UV Irradiation with UV … Read more
Analytical method validation, as guided by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), demands a nuanced understanding of the principles outlined in the document titled “Validation of Analytical Procedures: all the aspects and Methodology” are well explained in the below article, where precision and clarity, will embark on … Read more
The acronym COBB stands for “Capacity (or Cobb) Absorbency Test,” named after its inventor, F.N. Cobb. The COBB test is used to measure the absorbency and resistance to liquid penetration of paper or paperboard materials. The Cobb sizing test provides valuable insights into the suitability of paper materials for specific applications, allowing manufacturers to select … Read more
Explore the critical importance of Laboratory Incident Reports in the Pharma Industry. Learn how incident documentation, analysis, and corrective actions ensure safety, quality, and regulatory compliance. Types of Laboratory Incidents: Laboratory incidents can vary in nature and severity, and it’s crucial to be aware of the common types to effectively prevent, address, and mitigate them. … Read more
The SOP for Entry and Exit Procedure for Grade C Area in an injectable pharmaceutical manufacturing plant is of paramount importance for ensuring the safety, quality, and integrity of the products being produced. Here are some key reasons why this procedure is crucial: Contamination Control: Grade C areas in pharmaceutical manufacturing are critical zones where … Read more