8 STANDARDS AND PROCEDURES
Data Integrity: Compliance with
Data integrity is an old concept made essential in today’s digital age, and means data that is accurate, complete, and repeatable, which in turn ensures the product’s quality and public
safety. In recent years, infractions relating to data
integrity have been noted in several Food and Drug
Administration (FDA) warning letters. The impor-
tance of record-keeping in drug manufacturing can
be seen as far back as 1938, when the Federal Food,
Drug, and Cosmetic (FDC) Act required the safety
of new drugs be documented before being sold to
the public, with similar regulations instigated in
Europe and Japan throughout the 20th century.1
Production systems have large, inherent operational risks and are difficult to validate. Instead
of exclusively reacting to public health disasters,
preventative measures — such as the requirement
for proof of claims — are taken to lower their likelihood and instill confidence in manufacturers.
Presence in regulations
In the past few years, several FDA warning letters
(483s) have been issued for data integrity deficien-
cies in the pharmaceutical industry. In 2016, more
than 50 percent of MHRA warning letters involved
data integrity lapses for computerized systems com-
pared to the previous year. 4 Inspectors are actively
trained in data integrity requirements, and strongly
enforce them for falsified batch records or discharg-
ing of raw data.
Understanding recent standards, guides, and regulations pertaining to data integrity is essential to becoming
compliant. Relevant documents include 21 CFR Part 11,
MHRA: GxP, EU GMP Annex 1, the FDA Data Integrity
and Compliance with cGMP, and the WHO Good Data
and Record Management Practices. Inherent to data
integrity compliance is the goal of increasing product
quality, regulator confidence, brand reputation, and
process control, while reducing product defects and
costs. This applies to multiple areas of the pharmaceutical industry, including manufacturers of finished drug
products for clinical trials, bioequivalence studies and
commercial distribution, laboratories, contract manufacturing, suppliers, etc.
21 CFR Part 11
Title 21 of the FDA’s Code of Federal Regulations
(CFR) Part 115 is the most widely used standard for
appropriate data management. Part 11 applies to
records in electronic format that are created, modi-
Particle Measuring
Systems
All images: Particle
Measuring Systems
