We are a chemical distributor and repackager, and do business with pharmaceutical companies that require USP-grade products. Where can one locate "acceptable repackaging guidelines" for example, for packaging a USP-grade solvent in a 55-gallon drum?
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pharmamanufacturing Manufacturing Community Member 151 Posts
Re: Repackaging USP-grade Products29 July 2005 at 12:00am Last edited: 9 September 2013 at 6:31pmPeter Weiland responds:
It is extremely important, regardless of the USP claim, that the solvent be repackaged in a suitable container similarly to the manufacturer's recommendations. Basically, the same type of liner or coating would be correct.
Regarding the USP grade, this is unrelated to the container. The solvent must meet the USP (United States Pharmacopeia) monograph for the solvent. That means all testing and specifications conform to the monograph. Typically, the manufacturer provides a certificate of analysis, or C of A, to attest that it complies with USP.
Lastly, there actually is FDA guidance for repackaging, which can be found by searching www.fda.gov. Essentially, repackagers of pharmaceutical grade products must conform to GMP requirements that the original manufacturer was required to do. Repackagers also come under State licensing controls and inspections.
There have been a good number of repackagers that have not met suitable GMP requirements for repackaging pharmaceuticals. I am making an assumption that the solvent in question is used in a pharmaceutical process. If so, then proper handling and transfer, as well as maintaining good environmental controls, are important.