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  • 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 in Pharmaceutical Industries

    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...
    Jul 15, 2025

    Computerized System Validation Planning and Execution

    Computer validation planning consists of a Computer Validation Plan (approach), specific activities required to carry out the plan, and a Co...
    Jun 1, 2025

    Basics of Cleaning Validation

    Cleaning of pharmaceutical instruments after a product has been manufactured is critical to ensure that the subsequent products to be manufa...
    May 29, 2025

    Understanding the US FDA Drug Approval Process

    It is a multi-step journey to ensure safety, efficacy and quality to bring a new drug in the market in the United States. This journal is co...
    May 23, 2025

    How to Submit a DMF (Drug Master File)

    During document submission to regulatory agencies, the Drug Master File (DMF) plays an important role in pharmaceuticals in protecting confi...
    May 22, 2025

    FDA Expands Unannounced Inspections at Foreign Manufacturing Facilities

    Recently US FDA announced the expansion of unannounced inspections of foreign manufacturing facilities that produce medicines and medical pr...
    May 21, 2025

    CAPA Documentation: Common Mistakes to Avoid

    Corrective and preventive action (CAPA) is an essential aspect of the pharmaceutical industry's quality system required by agencies such...
    May 20, 2025

    Top 4 Problems in Sterile Pharmaceutical Manufacturing

    Sterile pharmaceutical manufacturing is the most demanding area in pharmaceutical industry. Injectable drug products and other formulations ...
    May 17, 2025

    Gemba Walks and Its implementation in Pharmaceuticals

    Compliance quality and efficacy are non-negotiable in pharmaceutical industry. It is required to implement management practices to improve c...
    May 14, 2025

    Effective Deviation Management in Pharmaceutical Manufacturing

    Deviations in pharmaceutical manufacturing are not only manufacturing mistakes but they are threats to product quality, patient safety and r...
    May 9, 2025

    Cleaning Validation of Clean-in-Place (CIP) Systems

    Cleaning of manufacturing equipment has great importance in the pharmaceutical and biotechnology industries. It is required to clean manufac...
    May 7, 2025

    How to Strengthen Microbiological Control of Non-Sterile Pharmaceuticals

    Microbiological quality of pharmaceutical products is essential for patient safety and product stability. As we know, the sterile products a...
    May 3, 2025

    The importance of FDA Form 483s and Warning Letters in Pharmaceuticals

    Compliance with good manufacturing practices is not optional in the pharmaceutical industry but is essential for public health and sustainab...
    Apr 30, 2025

    Importance of Data Integrity for Pharmaceutical Regulatory Agencies

    In the pharmaceutical industry, data is everything because data is a proof of work. Batch manufacturing records and raw data ensure that pha...
    Apr 28, 2025

    Best Practices in Pharmaceutical Microbiology Laboratory

    Microbiology lab in the pharmaceutical industry helps to identify microbial contamination in pharmaceutical products. Critical analysis like...
    Apr 26, 2025

    Sterile Pharmaceutical Manufacturing Area (Cleanroom) Cleaning

    Injectable products like ophthalmic solutions, vaccines and injectable drugs are manufactured in sterile cleanroom areas. Cleanroom area mus...
    Apr 25, 2025

    Understanding the Stability of Injectable Products

    Stability of pharmaceutical products is important to make those stable, safe and effective for a long time. When it comes to antibiotics, va...
    Apr 23, 2025

    Usages of Artificial Intelligence (AI) in Pharmaceutical Industry

    Artificial intelligence is being used in every field these days. It has revolutionary effects on the pharmaceutical industry by speeding up ...
    Apr 22, 2025

    Data Falsification in Pharmaceutical Industry

    Falsification of analytical and manufacturing data is not rare these days. You may think only one or two such cases are found yearly but stu...
    Apr 21, 2025

    Extraneous Peaks in Chromatographic Analysis

    Chromatography is a popular analytical technique that separates compounds on the basis of their properties and how they interact with statio...
    Apr 17, 2025

    Principle and Working of Gas Chromatography

    Gas chromatography is one of the most useful analytical tools in pharmaceutical and chemical laboratories. Because of its reliability and ac...
    Apr 16, 2025

    10 Tips for Fresh Graduates Seeking Jobs in the Pharmaceutical Industry

    In the real world of pharmaceutical carriers, it is challenging to find a dream job after graduation. For many fresh candidates, a question ...
    Apr 15, 2025

    Regulatory Compliance: 8 Common Mistakes and How to Avoid Them

    In the pharmaceutical industry, regulatory compliance is essential, not optional. Companies following regulatory guidelines not only protect...
    Apr 14, 2025

    10 Step Guide to cGMP Certification

    In the pharmaceutical industry, it is mandatory to get certified by regulatory agencies. GMP certification ensures the quality of pharmaceut...

    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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