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The QA Pharm

FDA Compliance

When All Else Fails, Lower Your Standards

This seems to be the thinking for two pharmaceutical manufacturers

Published: Friday, November 5, 2010 - 09:41

My definition of “specification” is rather simple: It’s a promise.

Just like any other promise, you’d better be sincere when you make it and be able to keep it. Failure to keep a promise brings disappointment. Frequent failure leads to distrust. And consciously breaking a promise is nothing less than deceitful.

Just as in our personal lives, the pharmaceutical industry makes a promise to its health care professionals and patients every time it establishes a product specification.

Whether it is a raw material or component from a supplier, in-process material, or final product, a specification is the industry’s promise to provide a product that possesses the attributes known to make it work.

Anything outside of the specification range is either unknown, because it has not been studied, or known to have some probability of a negative effect. Neither is acceptable.

The same could be said for process control ranges. Although they are applied to the manufacturing process and facilities, they nonetheless are “promises” based on a scientific field of study with respect to product quality.

Thus it seems to be particularly egregious when specifications and process controls are capriciously established or changed.

Take River’s Edge Pharmaceuticals, for example. A Food and Drug Administration (FDA) warning letter issued to the company on May 20 stated that Lidocaine HCL 3-percent  and Hydrocortisone 0.5-percent lots were released and distributed even though they had failed the initial release-and-stability viscosity testing at three-, six-, and nine-month time points. The firm responded by revising the specification range.

Additionally, after failing to investigate more than 30 complaints of discoloration of Hydroquinone 4-percent cream, River’s Edge responded that it would address the issue by revising the labeling to describe the cream as “tan to slight brown on storage.”

Another example is biopharmaceutical company Gilead. An FDA warning letter from Sept. 21 stated that the company’s aseptic processing room was not adequately constructed to meet design specifications. The room, in which a partially opened, sterile drug is transported, failed to meet ISO standards design criteria. The firm responded by reclassifying the room to a lower standard.

The FDA was not amused in either case.

Quality assurance is responsible for being the guardian of specifications and making sure that systems are in place and followed for developing and changing specifications.

It is a system based on statistical analysis of experimental studies, which is part of the process and product knowledge base. You know—the institutional knowledge of the scientific and technical aspects of what you make, how to make it, and why your specifications are what they are.

I am aware of some shoddy specification-setting practices, such as taking the highest and lowest values on record, plus or minus your shoe size, just to file FDA’s new drug application quickly in order to beat the competition.

But this always causes problems. Manufacturing processes are not efficient, and varied product attribute results are obtained. It all adds to a high nonconformance rate and adds cost to the operation.

Hence, a specification is not only a promise; if established properly you also get something in return. It’s the “sweet spot” for economical operations.


About The Author

The QA Pharm’s picture

The QA Pharm

The QA Pharm is a service of John Snyder & Co. Inc., provider of consulting services to FDA-regulated companies to build quality management systems and develop corrective actions that address regulatory compliance observations and communication strategies to protect against enforcement action. John E. Snyder worked at the lab bench, on the management board, and as an observer of the pharmaceutical industry for more than 30 years. His posts on The QA Pharm blog are straight talk about the challenges faced by company management and internal quality professionals. Synder is the author of Murder for Diversion (Jacob Blake Pharma Mystery Series Book 1).