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September 9, 2021 Life Science Consulting

Prepare for Your Next Audit: A 5-Point GMP Checklist

Vivian Jack, Managing Consultant, Quality Assurance and Charlotte Karlsson, Consultant ProPharma Group

Ensuring you have full control over your processes, facility, and quality management system (QMS), and ultimately your final product quality, is a demanding and important task. An inability to do so means you might be falling short of industry standards and required expectations. One way to ensure that you are in control is to perform an audit to review all your processes, procedures, systems, facilities, and more. These audits do not only ensure compliance with regulatory expectations, but most importantly support improving quality assurance for the products which are consumed by patients. Even during the current COVID-19 pandemic, it is important to continue your audit plans to be prepared for an (un)planned inspection. ProPharma Group offers remote or virtual audits to ensure your products and services are compliant and in line with guidelines.

Audits are a fundamental building block of supplier management systems (to control your suppliers). Internal audits are key to identify any gaps in your quality systems and/or processes. A checklist is a good tool to assist in conducting an in-depth and consistent audit in a systematic way and will address critical items needed to meet GMP requirements.

Below, I have prepared a checklist which consists of a sampling of questions from a full GMP checklist and can be used as a quick guide to evaluate your own system. These sample questions provide a reference to the type of questions that are used by an auditor when conducting a more comprehensive GMP audit. Ticking “Yes” on these questions will make sure you are on track when executing your next GMP audit.

  1. Incoming goods are received, inspected, and registered in a timely manner and not left unsupervised and/or left exposed to uncontrolled conditions.
    Yes No N/A
  2. There is a written procedure for management review, outlining management responsibilities.
    Yes No N/A
  3. The laboratory is appropriately sized and designed for the activities performed.
    Yes No N/A
  4. There are procedures in place to reconcile the labels where discrepancies are investigated and approved by quality.
    Yes No N/A
  5. There are tools for root cause analysis and risk analysis described and used.
    Yes No N/A

ProPharma Group provides both on-site and remote Good Manufacturing Practice (GMP) auditing for FDA and international regulated industries that manufacture, test, store, and distribute therapeutic and diagnostic products used in human and veterinary health.

With a diverse range of technical and regulatory compliance experience, we can address a wide variety of clients and suppliers, and will put the appropriate resources on each audit at the right time.

Our hands-on approach to GMP auditing is our way of collaborating with you to develop risk-based remediation plans, enhancing the level of quality and building on your existing programs.

Learn more about our comprehensive GxP Auditing solutions across the entire product lifecycle.

 



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