GMP Guidlines

  1. December 13, 2023

    Why are Pre-Approval Inspections (PAIs) Conducted? Get the free document

    Pre-Approval Inspections (PAIs) are crucial regulatory assessments conducted by pharmaceutical regulatory bodies to…
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  2. December 13, 2023

    Traceability and Compliance: GMP Equipment Logbooks Keep Pharmaceuticals Safe - Free document

    GMP equipment logbooks are essential for ensuring the quality and safety of pharmaceutical products throughout the…
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  3. March 08, 2019

    GMP Good Manufacturing Practice

    What is GMP - Good Manufacturing Practice ?We all know that microorganisms –…
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  4. March 08, 2019

    GMP Audit (Audit Personnel, Quality Documents)

    As a manufacturer bringing pharmaceutical product to the US market your company is always in the vigilant eyes of…
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  5. March 08, 2019

    Introducing you to cGMP for Quality Assurance

    Manufacturing of drugs is very often  a complex process – employees keep changing, efficiency of machines…
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  6. March 08, 2019

    GMP Complaint Handling System

    The Quality Assurance department is accountable that products being distributed for consumption are of good…
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  7. March 08, 2019

    GMP FDA Inspection

    FDA Inspection of Clinical Investigators Before a medicine is launched into market, it undergoes clinical trials to…
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  8. March 08, 2019

    FDA process-validation

    What Does the Revised FDA Process Validation mean to youThere has been several…
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  9. March 08, 2019

    GMP Failure Investigation

    GMP Failure Investigation: Identifying and Fixing the Root Cause The Code of Federal…
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  10. March 08, 2019

    GMP-OOS - Accepting the GMP Out-of-Specification Test Results

    The term Out-of-specification is used so often in pharmaceutical industry, but many of us are still unaware of…
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  11. March 08, 2019


    Preparing for Pre-approval Inspection Pre-approval inspection is a critical requirement…
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  12. March 08, 2019

    GMP Supplier-Audit

    Conducting a GMP Supplier Audit In order to reduce the cost, pharmaceutical companies…
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  13. March 08, 2019

    GMP Technical Agreement

    Composing a GMP Technical Agreement In today’s competitive environment, pharmaceutical…
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  14. March 08, 2019

    GMP Validation

    GMP validation is an element of quality assurance program for a pharmaceutical/biotech product or process. To…
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  15. March 08, 2019

    GMP Warning-Letter

    What is a GMP Warning Letter, Anyway?  The regulatory bodies – FDA and European…
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  16. March 07, 2019

    The FDA - The Food and Drug Administration

    Overview about one of the most important and biggerst Health Agencies in the world. The FDA - The Food…
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  17. March 07, 2019

    Guide for GMP Documentation and Records

    The management of each operational site is required to define responsibility for origination, distribution, maintenance, change control, and…
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  18. March 07, 2019

    GMP Compliance in a Pharmaceutical Company

    How to Sustain GMP Compliance in Your Pharmaceutical Company The pharmaceutical industry in every country is heavily…
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