The documented records and data created during the manufacture and quality control testing of pharmaceutical products and active pharmaceutical ingredients (API) serve as the sole legacy testifying to the quality, identity, purity and potency of those products. The legislation that governs the manufacture of medicines mandates that if the documented records created during the manufacture a batch of drug product or API does not conform to pre-established specifications, then that batch cannot be released for distribution and commercial sale.
It is clear that the integrity, reliability and trustworthiness of such manufacturing and testing records are of paramount importance. However, there have been a number of scandals, over the last ten years, where records have been wilfully manipulated to give a false impression that substandard batches of drug products and APIs conform to specifications. In the last ten years the US Food and Drug Administration (FDA) has issued over forty warning letters raising concerns regarding the integrity, reliability and trustworthiness of manufacturing and laboratory test records.
This has led to an increased awareness and scrutiny of the systems that pharmaceutical companies have established to assure the integrity, reliability and trustworthiness of drug manufacturing and testing records by both the regulatory agencies and customers.
We have over fifteen years of experience in assuring the reliability of laboratory records and data, and identify integrity issues and can provide the following:
Review of policies and procedures to identify potential data integrity and reliability vulnerabilities
On-site audit to identify any practices that may create exposure to potential data trustworthiness concerns
Developing and drafting of policies and procedures associated with assuring the integrity of data
Data review to assure integrity
Forensic investigation to identify unreliable data