IT issues at Biochem lab raise data integrity concerns

Citing an issue that cuts across all pharmaceutical testing and manufacturing, the FDA has called out a Biochem Laboratories contract facility for allowing employees to use the same computer login and password.

A common login means there is not an adequate audit trail for testing data. When Biochem responded that it would make everyone use unique identifiers, the FDA was not completely satisfied, saying Biochem needed to fully document changes in the process.

"You did not document the changes made to the software or data stored by the instrument systems. Without proper documentation, you have no assurance of the integrity of the data," the FDA wrote in a warning letter dated Feb. 17 and posted on its website this week.

The observations cited by the FDA at the Lyndhurst, NJ, facility included other significant breaches, like shortcomings in sampling plans and test procedures "designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity." But as Outsourcing Pharma.com points out, failing to keep computer passwords secure is an issue that plagues the industry. It points to a report in the Journal of Medical Internet Research that found password security is a problem in clinical trials. "It does not matter how strong a password is; if many individuals know that password then it is not a secure password," researchers wrote.

Among other problems at the Biochem New Jersey facility, the FDA cited:

-- Significant deficiencies in the spectroscopic and chromatographic assay procedures Biochem used to analyze finished drug products and stability samples;

-- The use of 11 USP drug substance monographs for analyzing finished drug products.that are not considered effective for the finished dosage forms being tested;

-- Use of unqualified secondary standards for the assay analysis of over-the-counter drug products; and

-- Glassware that was unlabeled, some that was not clean and some in the hood area oven that was frosted from chemicals.

- check out the FDA warning letter
- read the OutsourcingPharma.com story

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