Is the Data Integrity a Regulatory Requirement?

GMPs are minimum requirements that companies must meet in the development and execution of acceptable procedures for pharma manufacturingprocesses - from hygienic practices of employees and their work environments, to record keeping to how to handle returns and overages to specifications and testing of in-process and finished products.

Data integrity plays a key role in all areas of GMP compliance and FDA expects data to be meaningful, taking into consideration the design, operation, and monitoring of systems and controls based on risk to patient, process, and product.

In addition, FDA expects the data to be reliable, including a demonstration of integrity, validation, safety, identity, strength, quality, and purity, reproducibility and so on.

The integrity of data in support of a drug application submission is paramount to FDA’s evaluation and assessment of benefit versus risk.

With a keen eye to record completeness and whether the data package as a whole accurately and factually supports the application, a sponsor’s data is FDA’s only evaluation tool.

When viewed in this light, data integrity as part of an overall demonstration of GMPs is the lifeline of a drug company in that it has direct consequences in a firm’s ability to bring products to market.

Companies that cannot demonstrate good data integrity or robust GMPs will see delays and additional costs when seeking FDA approval.

Well developed SOPs, validation of equipment and other systems, as well as continuous employee education and training all lead to an improved ability to meet GMP and data integrity compliance.

Using the familiar acronym for data standards of  ALCOA, firms must ensure that data is Attributable to the person responsible for recording it; Legible so that a review of the data will give clear indications of results; Contemporaneous so that data entry is fluid. Data must also be Original, sometimes known as primary source data, or how it was initially recorded; and it must be Accurate and error free with all edits notated appropriately.

All data generated becomes part of the GMP record and must be recorded and saved at the time of performance to be compliant with FDA 21 CFR requirements pertaining to pharmaceuticals and biologics.

Code of Conduct for Data Integrity

The document is intended to apply to marketing authorization holders and pharmaceutical facilities performing services or providing products that are required to adhere to GxP practices in accordance with applicable laws, regulations and legislative directives of regulatory authorities including:

  • Good Manufacturing Practice (GMP)
  • Good Clinical Practice (GCP)
  • Good Pharmacovigilance Practice (GVP)
  • Good Laboratory Practice (GLP)
  • Good Distribution Practices (GDP)

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