J J Carpet

Pharmaceutical Quality: Is it a Company or Regulatory Responsibility?

Since details of dissolution issue are not elaborated, one can conjecture that the dissolution problems happened due to material that was used, was different from the specified material. Thorough analysis of off-spec material would have identified the problem and it should have been part of the report. Why this is omitted is an interesting question. Cepacia problem occurred due to contaminated raw material from the supplier. This suggests that either the specifications were not tight or some error happened. It should have been caught at the supplier’s lab or J&J lab during quality check before the product got used. FDA guidelines suggest that the companies check their incoming raw materials. I guess the company did not follow the regulatory guidelines. Production of “super potent” Tylenol is not only a failure of “good manufacturing practices (poor scale-up)” but also a failure of “good accounting/business practices” especially as it happened over a period of time. During the five-month period J&J produced 10 batches. Error of overcharge (between 11-24% over specifications) should have been caught as soon as they happened through material and cost variances, a standard practice of inventory and cost management controls. Since they were not caught immediately is suggestive of McNeil had issues with their operation and management systems. Since it took about five months, if it is true, to find out over charges it is suggestive that the whole Tylenol profit center needs a thorough scrutiny. It makes one wonder how many other things are being hid under the carpet? The following excerpt from the report needlessly points J&J’s problems to FDA regulations. It should not have been included as it basically suggests that US FDA’s cGMP guidelines are vague. It is like making FDA partially responsible for whatever happened at J&J. Similar implication could be extended to other global regulatory bodies. US FDA or any other regulatory body should not be blamed for J&J’s inaptitude. These regulatory bodies are not in the business of designing processes and methods for companies’ products and processes. It is the responsibility of the companies to ensure they have processes and methods that deliver quality products based on good science and engineering principles. The FDA is responsible for enforcement of the FD&C Act, and has promulgated regulations that require drug product manufacturers to employ “systems that assure proper design, monitoring, and control of manufacturing processes and facilities.” The FDA’s cGMP regulations are intended to “assure the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.” The FDA does not differentiate between the manufacture of OTC medications and prescription medications, treating both as drugs subject to the same cGMP requirements.

The Carpet And Rug Institute Blog: Carpet Manufacturer J&J ...

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