Regulatory Standards/GLP/GMP Compliance

The publication of a new FDA compliance policy for pre-approval inspections (PAIs) introduces a new objective to inspect research and development in pharmaceutical development. We explore how this could influence the PAI process now.

Now that the draft FDA guidance on computer software assurance (CSA) is out, we can see what it is—and is not.

A look at two ICH draft publications reveals that the EWG has much revision work to do for these publications to fully cover the validation lifecycle process.

It is traceability that shows that the ALCOA criteria does not exist in individual silos, but that they all interact with and are dependent upon each other.

We continue our explanation of the new PIC/S data guidance.

In the first article of a two-part series, the new PIC/S guidance is discussed, with particular focus on the scope, data governance, and paper records.

Computerized system validation (CSV) has an uninspiring reputation for being a slow, no-value-added activity that only wastes time and delays the implementation of new software. Is that an accurate portrayal? And is it a necessary evil?

“SneakerNet,” or the manual transfer of data using a disk or USB stick from one computer system to another, should be long dead, but this noncompliant transfer process still survives.

The calibration and qualification of analytical systems is a journey, not an event.

Two recent warning letters show that the US FDA is substantially increasing the amount of remediation work it requires for companies to correct data integrity noncompliance. That work can be very expensive—far exceeding the cost of ensuring compliance in the first place.

The California Department of Public Health has proposed to establish the first regulatory limit in the United States for hexavalent chromium (chromium-6) in drinking water. The proposed Maximum Contaminant Level (MCL) sets the limit for hexavalent chromium at 10 parts per billion. California, like those of other states and United States federal government, currently only regulates total chromium levels.

This article covers the changes so far to United States Pharmacopeia (USP) chapters <232> and <233>, the International Conference on Harmonisation (ICH), the European Medicines Agency (EMA), and the European Pharmacopoeia (EP), impending changes, and options for preparing for those changes.

In this column, Bob McDowall discusses the impact of USP general chapter 1058 on the spectroscopy laboratory.

Tracing requirements from a user requirements specification throughout the life cycle is not only a very effective business tool to save time and effort in validation projects but also a regulatory expectation. This first installment of a two-part column series looks at the principles of a traceability matrix.

This report demonstrates that it is possible to meet and exceed EPA "statement of work" requirements using ICP-MS.