US and EU harmonise safety regulations in pharma cold chain

PHARMACEUTICAL plant inspections will include further safety guidelines following agreements between the US Food and Drug Administration (FA) and its European Union counterparts to demand pharmaceutical manufacturers maintain best-practice on quality systems, said Bermuda's Textainer, a major lessor of shipping containers.

These agreements, said the Textainer press release, will help regulators be more efficient with their resources. Mutual agreement among agencies, combined with a focus on risk-based processes, raises the likelihood of more GxP (good practice quality guidelines and regulations) facilities being audited.

Revisiting cost-vs-benefit analyses for continuous monitoring modalities (wired or wireless networks and standalone monitoring instruments) that facilitate the ability to comply with auditors' requests for proof of regulatory compliance is very timely.

There are five approaches to monitoring critical environments such as pharmaceutical freezers, stability rooms and warehouses, said the Textainer statement. Quality, facility and IT managers employ different methods for maintaining the quality products and information.

Moreover, it said, the ever-increasing costs for Active Pharmaceutical Ingredients (APIs) and the research and development efforts to create them are such that the economic costs of failure in the totality of monitoring systems are greater than ever before.

All monitoring methods - wired, wireless or standalone instrumentation - need to be scrutinised for systemic weaknesses that allow human error to compromise product quality, system failure probabilities and overall costs of ownership, said the statement.
(Source:www.schednet.com)