FDA Inspects wrong plant in China

In an earlier published news in the blog 'Eye on FDA', it reports that FDA Inspects Wrong Plant in China!! This is only last weeks report. Oops!!! During what is not a good week for the FDA, following an announcement by the FDA of allergic reactions to Baxter's Heparin it is revealed in the news that the FDA inspected the wrong Chinese plant that manufactured an ingredient of Heparin. Though there is no link established between the ingredient and the reactions of patients to the Heparin about which the FDA issued an alert, the revelation is sure to shake up agency critics on the Hill, as evidenced by the statement of Rep. Rosa DeLauro, D-Conn., chairwoman of the House Agriculture, Rural Development, Food and Drug Administration Appropriations Subcommittee who likened the FDA with the Keystone Cops in an ABC Evening News piece this week.
And we thought- it happens only in India !

Container & Closure Integrity in Lieu of Sterility Testing in Stability Protocol

The FDA CBER website has yesterday (22/02/2008) published another guidance for industry titled 'Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products'.This guidance applies only to the replacement of the sterility test with an appropriate container and closure system integrity test in the stability testing program, recommending an alternative to sterility testing for supporting continued capability of containers to maintain sterility. The guidance does not apply to sterility testing methods for product sterility testing prior to release, as container and closure system integrity tests cannot demonstrate a product's initial sterility.Alternatives to sterility testing as part of the stability protocol,such as replacing the sterility test with container and closure system integrity testing, might include any properly validated physical or chemical container and closure system integrity test(e.g., bubble tests, pressure/vacuum decay, trace gas permeation/leak tests, dye penetration tests, seal force or electrical conductivity and capacitance tests, etc.),microbiological container and closure system integrity tests (e.g.,microbial challenge or immersion tests). The guidance can be dowloaded from:http://www.fda.gov/cber/gdlns/contain.htm . While the summary or review of this guidance can be read at: My reviews.

Integration of GMPs and Quality Management Systems - ICH Q10

There is really nothing new or anything different if you go through the ICH Q10 carefully!! Yes, it was already there. Reached to level 2 and released on May 2007, the new Guideline ICH Q10 "Pharmaceutical Quality System" defines that a documented Quality System should be established. Such a quality system should consider not only the GMP requirements but also further standards such as the ISO Standard 9001.
The Quality System shall ensure conformity of each manufactured medicinal product with the quality as specified in the product's marketing authorisation / registration.
Elements like Corrective and Preventive Action (CAPA) and Continual Improvement are covered as well as Management responsibilities and Design Control.