OR WAIT null SECS
December 02, 2005
A new oral dosage product was designed as "encapsulated tablets." In production, the drug product was pressed into tablets, which were then fed into a revolving capsule-filling table.
December 01, 2005
In applying a visually clean standard, any residue related to the cleaning process that is visible on the surface should constitute a failure.
November 03, 2005
US District Court Rejects FDA Suit to Block Device Manufacturer
November 02, 2005
"It was just after FDA had initiated the Pre-Approval Inspection process," reports our GMP Agent-in-Place.
This article provides a PhRMA perspective and recommendations on an FDA guidance currently under development dealing with postapproval changes after the final intermediate of the active pharmaceutical ingredient, i.e., BACPAC II. The concept of a "last true solution" is proposed as an additional point in the assessment of potential risk associated with process changes.
November 01, 2005
The extensible markup language (XML) format facilitates compliance with FDA's new requirements for prescription drug labeling submissions, improves patient safety, and enhances manufacturing sponsor efficiencies.
Information technology can streamline compliance and increase operational efficiency and quality.
Coordinating validation efforts throughout an organization requires an accurate and timely overview and a validation master plan (VMP).
Risk analysis and evaluation of software and computer systems is a good tool to optimize validation costs by focusing on systems with high impact on both the business and compliance.
Performing studies to mathematically 'correlate' swab and rinse sampling values does not add any value. What's more, do not expect them to mathematically correlate.