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  • Apr 10, 2024

    Data Integrity in Microbial Analysis

    Data integrity in microbial analysis refers to the maintaining and assuring the accuracy of the data that is being obtained from the raw inf...
    Apr 9, 2024

    Working of a HVAC System and Its Functions

    Heating, ventilation and air conditioning (HVAC) is the key to ensuring that the pharmaceutical products manufactured by an industry are of ...
    Apr 8, 2024

    FDA Warning Letters for Cleaning Validation

    Cleaning of equipment was first published in the Code of Feral Regulations (CFR) as 21CFR211.67 Equipment Cleaning and Maintenance in 1978....
    Apr 3, 2024

    10 Tips for HPLC Analysis In Pharmaceuticals

    HPLC, also known as High-Performance Liquid Chromatography system , is one of the most crucial analytical methods in pharmaceuticals. The pu...
    Apr 2, 2024

    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...
    Mar 29, 2024

    7 Steps for Monitoring Compliance in Pharmaceuticals

    Pharmaceutical manufacturing industry is a highly regulated industry that is regulated by different regulatory agencies from drug developmen...
    Mar 27, 2024

    Role of Lubricants in Tablets

    Lubricants are added to solid tablets and capsules to prevent the sticking of material to the punch, dies and compression machine during man...
    Mar 26, 2024

    Difference between FDA 483 and Warning Letters

    FDA inspects pharmaceutical manufacturing facilities to find cGMP violations. The observations are documented in form 483. If these observat...
    Mar 22, 2024

    Trends in GMP Violations in Pharmaceuticals

    All pharmaceutical companies have established strict guidelines and regulations according to current good manufacturing (cGMP) guidelines. T...
    Mar 21, 2024

    Guidelines for Drug Master File Submission

    1. Meaning of a Drug Master File DMF stands for Drug Master File which is a voluntarily submission at the holder’s discretion to help the c...
    Mar 20, 2024

    Tips for a Successful FDA Inspection in Pharmaceuticals

    It is the responsibility of the FDA to ensure that pharmaceutical products are safe and effective. To ensure this, the FDA inspects the phar...
    Mar 13, 2024

    Indian Govt releases guidelines on Pharmaceutical Marketing

    Indian government published the latest guidelines to prevent unethical pharmaceutical industry practices that can influence healthcare profe...
    Mar 12, 2024

    Risk Assessment for the Purified Water System in Pharmaceuticals

    The risk assessment is the process that helps to identify the risks associated with the process or system. Risk assessment is important for ...
    Mar 11, 2024

    4 Steps to Effective Change Control in Pharmaceuticals

    The pharmaceutical industry is the most impactful industry for human beings because it has direct impact on people’s lives. But the pharmace...
    Mar 6, 2024

    Event Tree Analysis (ETA) in Pharmaceuticals

    Event tree analysis (ETA) is a risk assessment technique that is used to sequence of events in a variety of industries. In pharmaceutical in...
    Mar 5, 2024

    Tablet Defects in Pharmaceutical Manufacturing

    Defected tablets are the most common problem in pharmaceutical manufacturing. These defects may occur in any stage of manufacturing from raw...
    Mar 4, 2024

    The Stratified Sampling Approach in Process Validation

    Pharmaceutical manufacturing is a perfectly systematic process that primarily relies on quality control to produce quality products. The goa...
    Feb 29, 2024

    Contamination Control Strategies for Manufacturing Area

    Contamination is a very serious issue in pharmaceutical manufacturing especially in sterile manufacturing. It is important to control the co...
    Feb 28, 2024

    New Drug Application (NDA)

    New Drug Application (NDA) are the documents about the product you want to manufacture and those are submitted to the government to detail t...
    Feb 27, 2024

    Case Studies: Troubleshooting Purified Water System Failures

    Purified water in the pharmaceutical industry is a critical component because it is used at various stages of pharmaceutical manufacturing. ...
    Feb 22, 2024

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

    The clean-in-place cleaning method is used to clean equipment that can not be disassembled or displaced like pipelines, tanks and large vess...
    Feb 21, 2024

    Regulatory Requirements and Guidelines for Cleaning Validation

    Cleaning validation is an important part of pharmaceutical manufacturing and regulatory agencies take it very seriously. FDA issues many war...
    Feb 20, 2024

    Enhancing Efficiency and Quality: Implementing Lean Manufacturing Principles in Pharmaceutical Manufacturing

    In pharmaceutical manufacturing product quality, efficiency and regulatory compliance have important roles. To maintain product quality and ...
    Feb 19, 2024

    Common Challenges in Pharmaceutical Manufacturing and How to Overcome Them

    The pharmaceutical manufacturing process is a highly regulated process that has different challenges related to manufacturing, quality and c...
    Feb 8, 2024

    Buffer Area and Its Maintenance in Sterile Facility

    The buffer area is the sterile zone in pharmaceutical manufacturing. Generally compounding area in sterile pharmaceutical preparation fac...
    Feb 7, 2024

    Data Integrity as per 21 CFR Rules

    Meaning of Data Integrity If you have been in the pharmaceutical industry for some time, you may have realized that protection of data fro...
    Feb 2, 2024

    Implementation of Six Sigma in the Pharmaceutical Industry

    Pharmaceutical companies are facing many challenges in the market where increased competition and rising cost of materials eat into their pr...
    Jan 31, 2024

    How to Eliminate Microbial Contamination from Classified Area

    We are receiving a lot of queries from pharmaceutical professionals that they have a lot of contamination in the classified areas. Contamina...
    Jan 30, 2024

    Difference Between Aseptic and Sterile Conditions

    The difference between "aseptic" and "sterile" is not always properly understood. These terms, which can be obviously us...
    Jan 25, 2024

    Tablet Manufacturing Process: An Overview

    In the tablet manufacturing process, powders are blended and then compressed into tablets. The powders must be of uniform size and weight so...

    About the Author

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

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