Documentation

Documentation in pharmaceuticals, good documentation practices in pharmaceuticals, Documentation and Records

 

Performance Qualification Protocol for Purified Water Generation & Distribution System (Phase-1)

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Performance Qualification Protocol for Purified Water Generation Distribution System

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 in Pharma Manufacturing

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Cross Contamination in Sterile Pharmaceutical Manufacturing

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 in Pharmaceuticals

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Deviation Management in Pharmaceuticals

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

Best Method to remove microorganisms from borewell water in Pharma Plants

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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 AMV in Quality Lab 24

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AMV e1706932466221

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

Cobb Tester and its Working Principles 2024

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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

Laboratory Incident report in Pharma industry 2024

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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

SOP for Entry and Exit Procedure for Grade C Area PRinj-02

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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

SOP for Entry and Exit for General Area PRinj-01

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SOP for Entry and Exit for General Areas of pharmaceutical plants are critical to ensure the safety, security, and compliance of the facility. These procedures are in place to protect both the employees and the products being manufactured. The specifics may vary from one pharmaceutical plant to another, but here are some general guidelines and … Read more

Riboflavin Testing and Procedurs 2023

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“To Enhance the Clean in Place (CIP) protocols with Riboflavin Testing. Explore how this advanced technique uses fluorescent dye to meticulously evaluate spray coverage within industrial vessels. Elevate your quality standards and regulatory compliance with effective cleaning validation.”Efficient Clean in Place (CIP) processes are vital for maintaining the cleanliness and functionality of stainless steel process … Read more

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