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  • Sep 26, 2023

    Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals

    1.0 OBJECTIVE 1.1  To define procedures for validating and maintaining the validation of all aseptic filling processes and qualification ...
    Sep 11, 2023

    NOEL and MACO Calculations in Cleaning Validation

    NOEL is “No Observed Effect Level” of any pharmaceutical drug. It is determined to calculate the MACO (Maximum Allowable Carry Over) in c...
    Sep 3, 2023

    Purified Water System Validation

    Water system validation (generation and distribution) should contain three phases: Phase I: investigation phase; Phase II: short-term cont...
    Sep 1, 2023

    Process Validation in Pharmaceutical Manufacturing

    1. Introduction Validation is an essential part of good manufacturing practices (GMP) . It is, therefore, an element of the quality as...
    Aug 30, 2023

    Purpose of Process Validation in Pharmaceuticals

    The kind of effort expended for Process Validation is largely determined by organizational structure. Whether Process Validation is mana...
    Aug 27, 2023

    System Suitability in HPLC Analysis

    HPLC, short for High-performance liquid chromatography is a technique used for separating the components in a mixture. In the HPLC techniqu...
    Aug 22, 2023

    Difference Between Dynamic and Static Pass Box

    In pharmaceutical manufacturing industries, pass boxes are normally used to transfer a particular material between two areas generally of di...
    Aug 17, 2023

    Different Types of HPLC Detectors

    HPLC detectors are used in the detection of the solute present in the eluent coming from the HPLC column . They are capable of determini...
    Aug 8, 2023

    Concept of GxP in Pharmaceuticals

    One of the biggest concerns that the pharmaceutical industry constantly attempts to address is the safety of its products. GxP is a collect...
    Aug 1, 2023

    Smoke Study in Cleanroom Areas

    The smoke study also known as dynamic air visualization study is the key qualification, maintenance and monitoring of facility to ensure the...
    Jul 24, 2023

    Different Types of Stainless Steel for Pharmaceuticals

    There are different grades of stainless steel according to the composition like 302, 304, 304L, 316, 316L, 410, 430, 440 etc. but all are...
    Jul 17, 2023

    Hold Time Study in Pharmaceutical Manufacturing

    Sometimes during manufacturing, the in-process materials need to be held for a period more than usual. Hold time study during manufacturi...
    Jul 7, 2023

    Quality Management System (QMS)

    Organizations engaged in the distribution, as well as the storage of materials along with products, should monitor, establish, maintain and ...
    Jul 3, 2023

    How to Write a Validation Protocol?

    A protocol is a written statement to conduct the validation process along with the procedure, test method, equipment handling, specificat...
    Jun 25, 2023

    Re-validation of Purified Water System

    Water is a critical ingredient widely used in the pharmaceutical industry for the processing, formulation, and production of pharmaceuticals...
    Jun 20, 2023

    Identification of Worst Case in Cleaning Validation

    It is not possible to carry out cleaning validation of all products manufactured in the facility. Therefore, products are selected on the ba...
    Jun 16, 2023

    HPLC System Software Validation Plan

    Introduction Softwares are used to operate and interpret the analysis results in HPLC systems. There are many softwares those are used in ...
    Jun 12, 2023

    A Brief Description of the Entire Audit Process in Pharmaceuticals

    Auditing in the pharmaceutical industry is an important tool to improve the efficiency and quality of products. It ensures the implementatio...
    Jun 10, 2023

    Sampling in Cleaning Validation in Pharmaceutical Industry

    Sampling in cleaning validation in the pharmaceutical industry has been a topic of ever-increasing interest and scrutiny in recent Food and ...
    Jun 6, 2023

    Planning and Execution of Internal Audits in Pharmaceuticals

    In any type of audit, the first and most important part is making a plan. In order to make the execution of audit of pharmaceutical effectiv...
    Jun 2, 2023

    Regulatory Guidelines on Data Integrity

    The pharmaceutical industry has been on the public eye for a long time now. People all over the world depend on quality medicine, safe to us...
    May 28, 2023

    Steps for HPLC Method Validation

    In the pharmaceutical industry, validation is an essential part of quality control and quality assurance. Various regulatory authorities giv...
    May 25, 2023

    Importance of Validation in Pharmaceuticals

    Validation is a documented evidence of the consistency of any process or system. It was firstly appeared in 1978 in the United States by...
    May 21, 2023

    Detergents Used for Cleaning of Pharmaceutical Equipment

    Cleaning is an important part of pharmaceutical manufacturing to manufacture contamination-free quality products. Facility cleaning and sani...
    May 19, 2023

    Components of GMP : GMP in Detail

    GMP stands for Good Manufacturing Practices in pharmaceuticals, it means to follow the regulatory standards during manufacturing of pharmace...
    May 17, 2023

    Importance of Data Integrity in cGMP: Ensuring Drug Safety and Quality

    In 2016 FDA published a guidance “Pharmaceutical Manufacturing/Quality Standards Data Integrity and Compliance with cGMP” to highlight the d...
    May 14, 2023

    New FDA Update on Glycerin, Propylene Glycol, Maltitol Solution and other Glycols

    FDA recently published a guidance for manufacturers and suppliers of the glycols to spread awareness about the potential health risk. In ear...
    May 11, 2023

    Calculation for Capacity of Tablet Coating Machine

    The quantity of tablets used for coating in coating pan plays a great role in getting good coating results. The capacity of the coating mac...
    May 6, 2023

    Root Cause Analysis with Examples

    Root Cause Analysis is the most important factor in determining the quality of each organization including the pharmaceutical industry, it i...
    May 3, 2023

    Possible Causes of Out of Specification

    Out of specification is the deviation of the product from the pre-determined specification. It means when a product is unable to meet the pr...

    About the Author

    Ankur Choudhary is experienced in pharmaceutical, author and founder of, a widely-read pharmaceutical blog since 2008.

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