Guidelines for Enforcing Good Documentation Practice in a GMP-Regulated Plant in 2024

Basic Principles of Good Documentation Practices in Pharma, Biotech & Medical Device Industry

GMP good documentation practices guide pharmaceutical manufacturers in developing and implementing procedures for creating and modifying documentation related to their products.

GDP establishes basic principles of pharmaceutical document management as baseline requirements that manufacturers can use to create detailed procedures that meet them. These basic principles are:

• Accuracy: Information must be recorded correctly and reflect the truth about what occurred during the process. Accuracy also includes capturing data in real-time to prevent errors or capture the wrong data entirely.
• Legibility: All documentation should be readable and understandable without ambiguity. Creating clear and direct documents ensures that anyone who reads the documents can follow and understand them.
• Traceability: The documentation should allow anyone to trace each significant step in manufacturing and controlling products, which is necessary for correctly identifying issues and compliance audits.
• Completeness: All data, including those that might negatively reflect on the product, must be recorded. Missing data could mean critical information about a product's safety, quality, and efficacy is unknown, which can jeopardize your compliance standing.
• Timeliness: Documentation must be updated after any activity or event as soon as possible to preserve data accuracy and relevance. Timeliness also plays into many of the above principles and is always necessary.

These established principles are elaborated on throughout GDP standards as specific processes are explored. Personnel should have a strong understanding of each of them and prioritize using them with any documentation-related task.

GDP in Practice

In a manufacturing plant, applying these principles means rigorously following procedures that support documentation integrity. So, let’s explore a few good documentation practices examples  to help demonstrate the above principles:

• Batch records: A common example is the creation of batch records, which should be completed in real-time, reviewed for mistakes, and signed off by supervisors daily.
• Equipment logs: Maintaining clear and updated logs for equipment use, cleaning, and maintenance. Any issues found during inspections or maintenance should be logged.
• Change control records: Document every change in process or equipment, including information such as justifications, approvals, and reviews. 

The examples are quick overviews that showcase when documentation is necessary and the attention to detail necessary during creation. The specific requirements found at every step are why GDP training is business-critical.

The Importance of Documentation Training for GMP Compliance

Personnel training is crucial for maintaining GDP and GMP compliance. Learning a single good documentation practices procedure can be a challenging task for a new employee, and since GDP can change over time, current employees can also start missing required details. 

Don’t underestimate the importance of initial and ongoing GMP compliance training for operators, managers, and anyone else involved in documentation — let’s break down a few reasons why:

• Ensuring compliance with GMP standards: Good Documentation Practices training equips employees with the necessary understanding to effectively implement GMP guidelines. This understanding ensures products are consistently produced and controlled to meet quality standards.
• Accuracy and error reduction: Train heavily emphasizes the importance of precision in documentation and includes strategies to minimize errors, such as double-checking entries and using error-proofing methods. These practices improve documentation reliability and enhance product quality and safety.
• Impact on regulatory inspections: Well-executed GDP training leads to thorough and accurate documentation, which can streamline regulatory inspections, reduce findings of non-compliance, and speed up approval processes.
• Facilitates continual improvement: GDP training encourages continual improvement by teaching employees to document routine operations and deviations precisely. This supports effective root cause analysis and corrective actions, enhancing manufacturing and quality control.

GDP and GMP compliance is not optional for most pharmaceutical and medical device manufacturing businesses. Providing employees with the opportunity to learn practical skills and knowledge is necessary for their performance and business health.

How to Develop or Identify Effective GDP Training

GDP training can be handled in-house, especially for ongoing education, or you can work with a specialized educator like CfPIE. Understanding what makes a GDP training program valuable and effective is necessary for both options.

So, let’s break down the important attributes any GDP training program requires to ensure your employees are prepared to follow documentation processes and maintain compliance.

Key Components of Effective GDP Training

Effective GDP training programs should comprehensively cover all aspects of GDP and bridge the gap between understanding the theory behind each principle and the real-world applications when put into practice.

Ideal GDP training will blend theoretical sessions and practical applications to enhance learning and retention. This blend can include workshops that allow hands-on experience and interactive e-learning tools that cater to different learning styles and paces.

Additionally, regular assessments, such as quizzes, practical demonstrations, and periodic audits of actual documentation, are necessary to ensure the training is effective and that the principles are correctly applied. These reinforce learning and identify areas that may require further training or clarification.

Best Practices for GDP Training Programs

Your training program, or a third-party’s program, should follow fundamental best practices to prepare graduates for real-world application of GDP principles. A few of these practices are:

• Customization: GDP training programs should be crafted specifically to the unique operational requirements and challenges your face. Aligning training content with the specific processes and compliance needs of the facility helps employees directly apply what they learn, enhancing the overall effectiveness of the training.
• Continuous improvement: Keep GDP training programs dynamic and effective by regularly updating them based on graduate feedback, evolving regulatory standards, and new technologies. An adaptive approach ensures that training remains relevant and effective, helping facilities stay compliant with evolving industry standards.
• Engagement: Utilize interactive and visually engaging training materials to enhance understanding and retention. Techniques such as gamification, simulations, and real-life case studies can make learning more appealing and memorable, leading to better application of GDP principles in the workplace.
• Feedback and surveys: Actively collect and analyze feedback from graduates through surveys and informal feedback channels after each training session. This feedback is crucial for identifying strengths and weaknesses in the training program and making informed improvements that enhance its effectiveness and relevance.

Each of these practices is designed to maximize the value each graduate is receiving from a GDP training program. Otherwise, you risk developing or partner with an ineffective program that does not prepare attendees for real-world applications.

Assessing the Effectiveness of GDP Training Initiatives

Understanding effectiveness isn’t just about components and best practices — ideal training will have a positive impact on graduates and job performance. Taking the time to evaluate your training initiatives or partner is necessary to avoid future issues with non-compliance or safety concerns.

One way to assess effectiveness is by collecting feedback and surveys post-training to identify areas that need improvement and evaluate graduates' understanding and application of GDP principles. These assessments should occur after all pertinent information has been taught and practiced, possibly as a final exam.

Once back on the job, monitor documentation errors and conduct routine audits to measure improvements and ensure the ongoing application of GDP principles. If applicable, conduct the same audits before training to better gauge improvement. 

Lastly, follow-up assessments and regulatory audit outcomes should be used to evaluate the long-term effectiveness of GDP training and the necessity for refreshers. If an audit fails or quality issues emerge, it’s time for additional training.

Effective Training is Crucial for GDP and GMP Compliance

GMP and GDP are strict quality standards that require precise processes and procedures. Nearly every aspect of documentation must meet these standards to stay compliant and ensure safe, effective final products. 

Training programs are necessary to teach employees the latest GDP standards and how to put them to work in a practical setting. Otherwise, developing the right workflows that will protect your GMP compliance is challenging. 

CfPIE is an industry-recognized leader that provides a wide range of training tailored to pharmaceutical and medical device manufacturing. Our courses turn any graduate into a certified document management professional, ready to develop or follow GDP standards.

Is your GMP-regulated plant following Good Documentation Practices at every step? Initial and ongoing employee training is needed to make sure you are — learn more about CfPIE’s courses today.

About CfPIE

The Center for Professional Innovation and Education (CfPIE) is the global leader in life sciences training, providing specialized courses for pharma/biotech, medical device, and skin/cosmetics topics. Classroom and custom on-site formats, and certification programs help improve personal skills, maintain regulatory compliance, and advance careers. Small class sizes and industry-active course directors promote a dynamic learning environment with excellent student-to-teacher interaction. More information: http://www.cfpie.com