CMO B has an SOP for identifying and investigating incoming raw materials for foreign matter. The SOP requires CMO B to characterize
foreign matter as either inherent or aberrant. If the foreign matter is deemed inherent to the raw material, a description
of the foreign matter is recorded as part of the raw-material release. The foreign matter is then removed and the raw material
is used in product formulation. If the foreign material is determined to be aberrant, then the raw material in question is
put on hold, and an investigation is initiated to determine the identification of the foreign material in question.
Most of CMO B's clients are comfortable with the SOP, but when manufacturing Company B's product, CMO B comes across some
black particles in sucrose, a raw material used in the manufacture of Company B's product. CMO B uses its foreign material
SOP to record the incident. The foreign-material report indicates, under high magnification, that the black material is burnt
sucrose. Because burnt sucrose is inherent to sucrose (the raw material), it is deemed suitable for manufacture. CMO B releases
the batch record and the associated product to Company B for review, approval, and release. Company B refuses to release the
product because its internal SOP, which was not provided to CMO B, specifies that foreign matter found in raw materials must
be sent for molecular identification. Until the discrepancies between the SOPs are resolved, product manufactured for Company
B is required to be released by exception.
The practice of using customized SOPs also presents a logistical problem for the CMO: Which SOP should be presented to the
regulatory authority during a cGMP inspection? For product-specific inspections, only those SOPs associated with the product
should be presented to inspectors. However, when a general inspection is combined with a product-specific preapproval inspection,
for instance, two SOPs for the same process must be provided to inspectors. Invariably, inspectors will investigate the areas
where the firm may have internal challenges and in all likelihood, will leave the CMO or the company with a an observation
that it "failed to follow written procedures..."
There are no easy solutions to the situations described. CMOs and their clients, however, can minimize these and similar types
of circumstances through open communication. CMOs must seek to understand their clients' needs while clients must seek to
understand their CMOs' quality systems. Although we are all in the same industry, we do not always share a common language
with respect to describing our internal systems. Establishing a common language between the two parties makes it easier to
determine what, if any, changes need to be made to a CMO's quality system to accommodate the client's needs. If the two parties
can effectively communicate and eliminate the need for redundant SOPs, their chances of avoiding unfortunate compliance mishaps
will greatly increase."
Susan J. Schniepp is vice-president of quality at OSO Biopharmaceuticals, susan.schniepp@mac.com
.
REFERENCE
1. J. Moldenhauer, Pharm. Technol. Europe, 23 (4) 44–51, 2011.
2. FDA Reading Room,
http://www.fda.gov/ICECI/EnforcementActions/WarningLettersdefault.htm
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