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  • Dec 2, 2025

    Validation of Shelf Life for 70% v/v Isopropyl Alcohol | IPA Efficacy Validity Determination

    Isopropyl alcohol 70% is one of the most commonly used disinfectants and the pharmaceutical industry. It is used for surface disinfection, e...
    Dec 1, 2025

    USFDA Guidelines for Pharmaceuticals | Complete FDA Compliance Guide

    USFDA has great importance in ensuring the safety, efficacy and quality of pharmaceutical products sold in the United States market. The gui...
    Nov 29, 2025

    Purified Water Systems in Pharmaceuticals | Types, Design, and Uses

    One of the most pronounced ingredients in any pharmaceutical engineering is water. Water serves as a solvent and ingredient for formulation ...
    Nov 28, 2025

    Color Codes for the Gas Cylinders in Pharmaceuticals | ISO and BIS Color Codes

    Gas cylinders are widely used for various purposes in pharmaceutical industry from sterile operations and laboratory testing to manufacturin...
    Nov 26, 2025

    Understanding GxP in Pharmaceuticals | Types, Purpose, and Importance of GxP

    One of the biggest concerns that the pharmaceutical industry constantly attempts to address is the safety of its products. GxP is a collecti...
    Nov 24, 2025

    Different Mesh Sizes and Mesh to Micron Conversion

    Sieves and screens are widely used in pharmaceutical manufacturing as well as in the quality control to determine the particle size of the r...
    Nov 21, 2025

    Purified Water System Validation | Steps, Phases, and Compliance Guide

    In pharmaceutical industry, water is the most critical utility used in manufacturing process and washing of equipment. It is used as the raw...
    Nov 20, 2025

    Sustained Release and Prolonged Release Tablets and their Difference

    In modern drug delivery the focus is not just on developing new molecules but on achieving maximum therapeutic benefits from the dose with m...
    Nov 18, 2025

    Lessons from Major Regulatory Non-Compliance Cases

    In the pharmaceutical industry, regulatory compliance is not optional but it is the foundation of trust, product safety and patient health. ...
    Nov 16, 2025

    Basics of HVAC System and Its Components, Working, and Airflow Diagram

    Air conditioning has changed over the years, the HVAC system is used to control the environment in the manufacturing as well as the storage ...
    Nov 14, 2025

    21 CFR Part 11 Requirements for Laboratories | Tips for Compliance

    In pharmaceutical laboratories electronic data systems have replaced paper documentation. Instruments like HPLC, GC, Spectrophotometer and s...
    Nov 11, 2025

    Preparation of Buffer Solutions (Phosphate, Acetate and other Buffers)

    Buffer solutions play an important role in ensuring product stability and providing environment for chemical and biochemical reactions. Buff...
    Oct 29, 2025

    ALCOA, ALCOA+ and ALCOA++ Principles | Ensuring Data Integrity in Pharmaceuticals

    The term ALCOA is an Acronym, which stands for Attributable, Legible, Contemporaneous, Original and Accurate. ALCOA was then expanded to ALC...
    Oct 28, 2025

    Introduction, Classification and Definitions of Dosage Forms

    Introduction to Pharmaceutical Dosage Form Drugs are rarely delivered as pure chemical entities but are approximately usually provided as pr...
    Oct 27, 2025

    Climatic Zones for Stability Studies | Climatic Zone Classification & Conditions

    Stability study is an important part of pharmaceutical product quality. For safety, efficacy and quality of pharmaceutical products, environ...
    Oct 11, 2025

    Auditing Suppliers: What Pharmaceutical Auditors Look for and How to Prepare

    In pharmaceutical industry materials are supplied from different suppliers. Supplier audits are a critical part to ensure the quality and sa...
    Sep 24, 2025

    Environmental Monitoring Trending | How to Set Alert/Action Levels Based on Data

    In sterile product manufacturing where microbial contamination directly impacts product quality and patient safety environmental monitoring ...
    Sep 22, 2025

    Media Fill Validation Test in Sterile Pharmaceutical

    In the pharmaceutical industry, the product quality is directly dependent on aseptic conditions maintained in manufacturing area. Media fill...
    Sep 18, 2025

    Analytical Method Validation in Pharmaceuticals | Step-by-Step Guide to AMV

    In pharmaceutical quality control, analytical method validation (AMV) is one of the most critical aspects that helps to ensure that methods ...
    Sep 15, 2025

    Water for Injection (WFI) System Validation in Pharmaceuticals | A Complete Guide of WFI System

    Water used as a raw material in pharmaceutical manufacturing industry. There are different grades of water used in pharmaceuticals but Water...
    Sep 12, 2025

    Process Validation in Pharmaceutical Manufacturing

    Process validation is an essential part of good manufacturing practices (GMP) . It is, therefore, an element of the quality assurance progra...
    Sep 6, 2025

    Analytical Method Transfer in Pharmaceuticals | AMT Process, Challenges, and Best Practices

    In pharmaceutical industry analytical methods are the heart of quantity control analysis from analysis of raw materials to confirm their ide...
    Aug 25, 2025

    Autoclave Validation in Pharmaceuticals | A Complete Guide to Sterility Assurance | Validation of Steam Sterilizer

    In pharmaceutical manufacturing facilities, sterilization is one of the most critical processes. Any error in sterility testing can compro...
    Aug 12, 2025

    HVAC System Validation in Pharmaceuticals | A Complete Guide to Compliance and Best Practices

    In pharmaceutical manufacturing, HVAC system plays an important role in maintaining controlled environmental conditions that are necessary f...
    Aug 11, 2025

    Deviation Control in Pharmaceuticals | Steps, Documentation, and GMP Compliance

    Maintaining product quality and ensuring patient safety are the most important tasks in pharmaceutical industry. Unplanned events are one of...
    Aug 4, 2025

    Change Control in Pharmaceuticals | Process, Documentation, and GMP Compliance Guide

    Changes are always made in industries but in pharmaceutical manufacturing changes must be planned, documented, justified and approved. Any m...
    Aug 2, 2025

    Current Good Manufacturing Practices (cGMP) | Complete Guide for Pharmaceuticals

    Current Good Manufacturing Practice (cGMP guidelines) requirements are set up by the Food and Drug Administration (FDA) and serve as the ben...
    Jul 31, 2025

    How to Review GMP Documents Like a Pro

    GMP in pharmaceuticals plays an important role in document maintenance, compliance and product quality. Pharmaceutical documents like batch ...
    Jul 24, 2025

    EMA vs FDA Expectations on Process Validation

    In pharmaceutical manufacturing validation of manufacturing process ensures that the manufacturing process is consistent and producing a pro...
    Jul 21, 2025

    Regulatory Expectations from Cleaning Validation

    Cleaning validation is an integral part of the pharmaceutical manufacturing process. A piece of equipment itself can contaminate the product...

    About the Author




    Ankur Choudhary is experienced in pharmaceutical, author and founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008.
    Email: info@pharmaguideline.com

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