Good Documentation Practices (GDP) serve as the foundational elements of a
robust Quality Management System. Mandated by numerous regulatory bodies,
GDPs are essential for ensuring product quality and compliance. This blog delves into the core principles underpinning GDPs.
What are Documents?
Documents encompass a wide range of materials, including procedures, specifications, and records. Examples of documents within a regulated environment are Standard Operating Procedures (SOPs), protocols, batch manufacturing records, raw data, test results, equipment validation records, calibration records, and training documentation. Both paper and electronic formats can be utilized for document storage.
Data Integrity: The Heart of GDP
Data integrity, a critical component of GDP, signifies the completeness, consistency, and accuracy of data. Adhering to the ALCOA+ principles, a framework adopted by regulatory authorities such as the US FDA, EMA, and WHO, is paramount for maintaining data integrity throughout the data lifecycle.
The GDP principles must be applied through all phases of the data lifecycle.
The ALCOA+ Principles
While the original ALCOA principles provide a strong foundation, additional elements have been incorporated to enhance data integrity.
GDPs are instrumental in achieving and maintaining product quality. By understanding the fundamental principles and implementing robust practices, organizations can enhance their compliance posture and mitigate risks.
In our next blog, we will discuss practical ways to apply the ALCOA principles.
Our Services
We conduct audits of documentation practices using a customized ALCOA checklist. If you seek an independent evaluation of your documentation system, please don’t hesitate to contact us.
