Globepharm Consulting ‚ÌGMPŠÖ˜A‹Æ–±‚Ì‚²ˆÄ“à


TBA contamination leads to European product recalls@Sat 28 May 2011


Date: Sat, 28 May 2011

Dear Friends:
TBA (2,4,6-tribromoanisole), used to preserve wooden pallets, has been blamed for the need for Johnson and Johnson to recall some product sold in Europe (see attached article).
It seems that the TBA impregnated into pallets used to store glass bottles in the pallets had volatilized, and had migrated into the bottles, causing a musty odor to permeate the products. This has been a problem reported several times, by several companies, in the USA.

Many companies are now actively seeking to replace wooden pallets throughout their supply chain. If you have not started such a program, it might be worth evaluating your supply chain practices.

We at Globepharm continuously strive to keep current on global changes to GMPs, regulations and guidelines as well as with other changes (e.g. Pharmacopoeal changes) impacting the healthcare manufacturing industry world-wide. We specialize in providing GMP audits and GMP training such that our clients never fail FDA, EU, WHO or other regulatory inspections. If we can be of assistance, in any manner, please do not hesitate to contact us.

With Best Regards,

Michael Anisfeld
Globepharm Consulting
313 Pine Street (Ste 204)
Deerfield IL 60015, USA

e-mail: manisfeld@globepharm.org
ph: USA +1 847 914 0922


Attachment: TBA-1105ePharm Tech







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