Good Documentation Practice (GDP) is a set of guidelines and procedures established to create, review, approve, distribute and maintain documentation within regulated industries such as pharmaceuticals, healthcare and manufacturing. The guidelines for GDP were created to address the specific documentation requirement within Good Laboratory Practice (GLP). 

GLP is a set of principles and guidelines initially introduced by the Organization for Economic Co-operation and Development (OECD) in the early 1970s due to concerns about the reliability and validity of safety data generated for regulatory submissions. GLP defines how non-clinical safety studies should be conducted to assure the quality and integrity of the data generated, as well as standardizing the way of conducting studies. This in turn ensures their scientific integrity and regulatory acceptance. 

Good Documentation Practice plays a critical role within this framework. Proper documentation allows the reconstruction of the entire study process such as experimental design, procedures, observations, data analysis and results. The GDP guidelines ensure transparency, traceability as well as the ability to verify the integrity of the study. These guidelines highlight the importance of accurate and complete documentation of all study related activities by providing specific recommendations for format, content and management of various types of documents including protocols, standard operating procedures (SOPs), raw data, final reports and amendments.

Principles of GDP in GLP

The principles of Good Documentation Practice in GLP include:

1. 1. Legibility: All documentation should be clear, concise, easily readable and understood by others.
   2. Traceability: Each document should contain enough information pertaining to the study, study phase and the personnel involved.
   3. Accuracy: All recorded data should be true and reflect exactly what was observed or performed.
   4. Completeness: Documents should provide a comprehensive record of the study activities including any deviations or unexpected events without any exclusions.
   5. Timeliness: Documentation should be completed promptly to ensure that observations, results and other important information are recorded in a timely manner.
   6. Archiving: Documents should be organized and stored safely to enable easy retrieval and long term preservation in a controlled and secured environment.

These principles of Good Documentation Practices therefore promote consistency, reliability and transparency in GLP studies. By adhering to the GDP guidelines, this allows the reproducibility of study findings, facilitates regulatory compliance and supports the overall Quality assurance process in non-clinical safety assessment.

The Role of Quality Assurance in GDP Compliance

The Quality Assurance (QA) role is to ensure that good documentation practices (GDP) and processes are compliant with established regulatory standards. This in turn supports the maintenance of high-quality documentation throughout the organization. In order to ensure that GDP principles are followed within the organization, the QA uses various methods such as documentation control, compliance monitoring, training awareness, change control, audit and inspection support for continuous improvement. 

The US Food and Drug Administration (FDA) also has developed guidance regarding GDP. FDA has introduced the acronym ALCOA which stands for Attributable, Legible, Contemporaneous, Original, and Accurate. This applies to both paper and electronic data and have been used by various regulated industries to ensure the integrity of data produced.

As a GLP certified organization by Standards Council of Canada (SCC), Biopharma Services Inc. understands that data reliability and integrity are crucial to any GLP and GCP (Good Clinical Practice) studies. BioPharma Services has systems and processes such as Quality Control and Quality Assurance in place to ensure the research is conducted, and the data produced is of high quality. One of the ways this is attained is by following Good Documentation Practice (GDP). 

At BioPharma Services, we have clearly defined Standard Operating Procedures (SOPs) in place to make sure good documentation procedures are followed by all staff involved in all projects. This validates that all raw data documented complies with GLP and GCP principles. All data entry must be completed by the person who performed the task by documenting their initials and the date it was performed. All corrections are done according to our SOPs to ensure transparency and traceability. For electronic data, audit trails are in place and are reviewed to ensure data integrity.

BioPharma Services has its own SOPs detailing the requirements for producing scientific and study related documentation procedures to align with Good documentation practices, GCP and GLP. This includes having specific format to document dates, molecular weights, concentrations, significant figure requirements for various calculations and standard ways to make corrections and/or clarifications. These procedures are put in place to ensure that all staff are adhering to these principles on their documentation.  This allows for an easy and efficient review of all data generated here at BioPharma Services. 

Since BioPharma Services conduct different types of studies such as Bioequivalence (BE), Phase 1 clinical trials and non-clinical GLP studies, it is vital to maintain the same rigorous documentation and high levels of quality assurance to ensure the data integrity and validity of all results. The adherence to GDP to all facets of the company becomes critically important to the success of such studies and subsequently to the approval and marketability of the drug analyzed. 

Digital Transformation and Good Documentation Practice

As we move further into the digital age, the Good Documentation practices are also evolving. Companies are shifting from paper-based systems to electronic documentation systems. This transition is not without its challenges, but it has become an imperative move to meet increasing data volume, ensure data integrity and simplify regulatory compliance.

Challenges in Implementing Electronic Documentation Systems

Implementing an electronic documentation system comes with its set of challenges. Transitioning from a paper-based system to a digital system can be a complex process, requiring significant time and resources. It demands a complete redesign of the documentation workflow and may necessitate staff retraining. The issue of data security and privacy becomes even more critical with electronic documentation. Rigorous encryption and security measures must be put in place to protect sensitive data from breaches and unauthorized access. Regular audits of the system are required to ensure its security and reliability.

Benefits of Electronic Documentation Systems

Despite the challenges, there are significant advantages to implementing electronic documentation systems. Electronic systems can handle larger volumes of data more efficiently. It eliminates the possibility of human error in manual data entry, thereby increasing the accuracy of the data. Data can be easily retrieved and changes can be tracked and traced, providing greater transparency and traceability. Electronic systems also simplify compliance with regulations, as they can be programmed to adhere to the requirements and standards set by regulatory bodies.

At BioPharma Services, we understand the importance of staying current with technological advancements. We have taken steps to implement electronic documentation systems [EDC], maintaining our commitment to adhering to Good Documentation Practice. We have put in place comprehensive security measures and conduct regular audits to ensure the security and integrity of our data. Our team has been trained to adapt to the new system, and we have witnessed improvements in efficiency, data accuracy and regulatory compliance. As we continue to navigate this digital transformation, we reaffirm our commitment to maintaining the highest standards of Good Documentation Practice. 

Why Choose BioPharma Services?

The importance of Good Documentation Practice cannot be overstated. It is crucial in ensuring the quality, reliability and integrity of the data to support regulatory compliance and to foster trust between the organization and the regulatory bodies. Whether through traditional paper documentation or modern electronic systems, adhering to GDP is a top priority for BioPharma Services. We continue to invest in practices, procedures and systems that uphold and promote these principles to maintain our commitment to delivering high-quality, reliable data for non-clinical safety studies.

Written By: Fathima Radiya Rafeek, Senior QA Team Lead.

BioPharma Services, Inc., a Think Research Corporation and clinical trial services company, is a full-service Contract Clinical Research Organization (CRO) based in Toronto, Canada, specializing in Phase 1 clinical trials 1/2a and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma has clinical facilities both in the USA and Canada with access to healthy volunteers and special populations.