Merck Slapped With GMP Warning Letter for Vaccine Operations
Posted by kandylini on May 11, 2008
The redacted warning letter has references to:
* Over-pressurization of vials
* Shed fibers in lots
* Failure to quarantine numerous process intermediates associated with the use of [redacted] filter membranes that were identified to cause foaming during filtration. This foaming was found to be associated with leaching of [redacted] into process intermediaries. These process intermediaries were used to further manufacture MMRII, PedvaxHIB [...]
* APR 2006-204C-0034 dated 8/24/2006 was issued for the sterility failure of Pedvax bulk lot [redacted]. The contaminant was noted as [redacted].
What a mess! My curiosity is piqued—what was the contaminant in the Pedvax Hib? How many babies were injected with this non-sterile contaminated vaccine? What in the world is a “process intermediary”?
Source: FDA News.
Merck’s bulk drug substances used to manufacture many of its vaccines are adulterated, and the FDA is requesting a meeting with senior management to expedite the firm’s corrective actions, according to a recent warning letter.
The FDA cited the company for numerous GMP violations at its vaccine production operations, including those for human papillomavirus vaccine Gardasil and combination measles, mumps, rubella and chicken pox vaccine ProQuad.
The warning letter resulted from an inspection at the firm’s West Point, Penn., facility between Nov. 27, 2007, and Jan. 17. The facility produces most of Merck’s vaccines, the company said. The inspection resulted in 49 Form 483 observations.
In a question-and-answer statement, the FDA said the deviations do not affect the safety of Merck vaccines, and no shortages are expected.
Merck has been plagued with manufacturing problems for its vaccines containing varicella. Potency issues for bulk varicella have created supply disruptions for Zostavax and ProQuad, which is not available for purchase.
During Merck’s first quarter earnings call, CEO Richard Clark said the FDA is reviewing regulatory submissions for a new varicella manufacturing process.
The warning letter can be accessed here.
