GDP – far-reaching within all GxP-compliant organizations, and yet it can be a challenging point for many during audits. GDP, or Good Documentation Practices, are essential to maintaining an effective QMS. In a previous blog post, we touched on GDP, ALCOA+, and recommendations for successful GDP practices. In this post, we’re going to take a deeper dive into GDP, the governing regulations, and tips on consistently maintaining GDP.  

As a refresher, GDP, or Good Documentation Practices, are guidelines for documentation activities within CGMP-compliant organizations. GDP is a component of CGMP and is governed under 21 CFR Part 211 and under FDA-QSR, 21 CFR Part 820. Documentation within the scope of a QMS is extremely important. There’s a common saying within the industry that ‘if it wasn’t documented, it didn’t happen.” Taking it a step further, good documentation practices ensures that organizations abide to data integrity, and failure to do so can have serious consequences, especially within the medical device and pharmaceutical industries. The FDA introduced a principle called ALCOA+ within GDP to ensure data integrity. ALCOA+ stands for attributable, legible, contemporaneous, original, and accurate; the plus ensures that data is complete, consistent, enduring, and available. The intent of ALCOA+ is to raise awareness and responsibility among all employees within an organization about GDP and data integrity. GDP is everyone’s responsibility to ensure the safety and efficacy of public health.

GDP can be maintained consistently so that it does not become scramble a week before re-certification or an audit. For example, consider implementing lean six sigma concepts of collaboration, efficiency, and waste reduction when addressing GDP. First, foster a workplace culture in which all employees feel involved and responsible for maintaining GDP (and they are!). Employees who understand the value of ALCOA+ will be more likely to follow GDP guidelines. Encourage workers to address GDP immediately and not to wait until before an audit. Continue to administer refresher trainings on GDP and ensure that GDP is addressed clearly and thoroughly during onboarding. Finally, automated system checks for GDP would be ideal, but in the case when implementation is not possible, consider incorporating human verification in your processes.

GDP is not only the bread and butter of QMS maintenance, but a critical component of ensuring safety and efficacy of the public health when using these marketed products. In addition, GDP will be evaluated during any audits or certification efforts. GDP can absolutely be maintained through collaborative and forward-thinking efforts. If your company needs assistance in implementing a documentation management system or preparing for an audit/certification, EMMA International can assist. Contact us by phone at 248-987-4497 or by email at info@emmainternational.com.

Jenifer Kang

Jenifer Kang

Jenifer is a Quality Engineer at EMMA International. She has experience in quality assurance operations, nonconforming product management, issue evaluations, and statistical analysis within the medical device industry. She has experience collaborating and auditing within a manufacturing environment. Jenifer also has academic, work, and/or volunteer experience with stem cell research, mycotic diseases, and pediatrics healthcare. Jenifer holds a Bachelor of Science in Biology with a Minor in Health and Medical Sciences and a Master in Biomedical Innovation and Development from Georgia Institute of Technology. She also earned a lean six sigma green belt certification.

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