the drug, the Facilities and procedures. This explains why all problems occurred at one physical location. ??
I think hypersensitivity would be the easier fix. If GMP was the problem, it would require tedious and time consuming testing of many batches of product and throwing away each contaminated batch until the site of contamination were found. Unless proceedure of GMP was flawed and did not require adequate strerilization / flushing between batches.
A good manufacturing practice (GMP) is a production and testing practice that helps to ensure a quality product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation. Basic concepts of all of these guidelines remain more or less similar to the ultimate goals of safeguarding the health of the patient as well as producing good quality medicine, medical devices or active pharmaceutical products. In the U.S. a drug may be deemed adulterated if it has passed all of the specifications tests but is found to be manufactured in a condition which violates current good manufacturing guideline. Therefore, complying with GMP is a mandatory aspect in pharmaceutical manufacturing.
Although there are a number of them, all guidelines follow a few basic principles:
Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)
Operators are trained to carry out and document procedures.
Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented.
Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
The distribution of the drugs minimizes any risk to their quality. cont.
Think about it in a common sense way, if it was the drug itself then the allergic reactions would have been spread out evenly throughout the timeline of the 25,000 patients, but......it was not, it was all in the same window of time at the same facility! I'm no expert by any means, but I do have to agree with raj. and others who believe the Drug has been cleared and now the investigation has turned to the manufacturing aspect?