How To Make Sure Your Foreign Vendors Are FDA Compliant — And Stay That Way

Vendor selection is a serious process. Manufacturers are responsible for compliance from their selected vendors, and any violations by vendors can cause serious problems for the manufacturers. Choosing a foreign vendor is no different than choosing a domestic vendor; foreign vendors are held to the same FDA standards as domestic vendors. Manufacturers must have assurance

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Effective Analytical Method Transfer Between Two Labs

As per the USP, the transfer of an analytical method is defined as the documented process that qualifies a laboratory (receiving laboratory) to use an analytical method that originated in another laboratory (transferring laboratory), whether that is internal or external to the receiving laboratory. These two types of laboratories can have varying relationships. The improvement

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BASIC GUIDELINE FOR EFFECTIVE SOP WRITING

Inappropriate Standard Operating Procedures (SOPs) are one of the most commonly cited reasons for Forms 483 and Warning Letters on the completion of an FDA inspection. Now, keep in mind that particular SOP concerns can regularly be followed back to poor correspondence, checking, as well as requirement, an inadequate written SOP can discreetly develop into

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