GCLP COP Articles

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Technical Articles

  • Handling of Product Complaints ( 123 KB)
    Handling of complaints is an important part of Good Manufacturing Practice. Complaints could be received from customers, regulators or from within the organization.
  • Basic Design Considerations ( 430 KB)
    Basic Design Considerations for a Testing Laboratory
  • Calibration in a Pharmaceutical Quality Control Laboratory ( 75 KB)
    Dr. A.V. Prabhu of the GCLP Steering Committee gives an overview of the regulatory aspects and essential requirements of a good calibration system.
  • Laboratory Reference Standards ( 84 KB)
    A laboratory should prepare a complete list of the reference standards or materials they use. An article by J. L. Sipahimalani gives an overview of this topic.
  • Quality Risk Management - A Study ( 73 KB)
    An article by Kapil Bhargava discusses Quality Risk Management in the laboratory. The article was published in April 2009 by the Indian Drug Manufacturers’ Association and Association of Pharmaceutical Analysts (IDMA-APA).
  • Laboratory Management ( 457 KB)
    The importance of the management of quality is the focus of an article by the late R.S. Iyer, published in April 2009 by the IDMA-APA.
  • Sampling: Its Importance in the Pharmaceutical Industry ( 125 KB)
    An article by Raghu Raghunandanan, Chair of the GCLP COP, gives an overview of sampling and the plans, risk-assessment, methods, SOPs, post-sampling precautions, and regulatory requirements related to sampling.


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