New FDA inspection system

GMP News Nr. 113

GMP News
30 June 2001
NewFDA inspection system

FDAhas launched a pilot program for inspection systems in routine GMPinspections. It focuses to an increased extent on the function of theQuality Unit as the key element of the company-internal compliance status.FDA is sending a clear signal here to the pharmaceutical industry that itexpects a functioning Quality Unit (QU) which has all the necessaryregulating mechanisms and which is also strong enough to prevent productsof inferior quality from entering the market.

Whyis FDA focusing so much on the QU?

Twotrends were decisive for this. On the one hand FDA's experience that dueto staff reductions and personnel fluctuation in the Quality Unitsknowledge about specific products and processes have been lost with theresult that proper troubleshooting is no longer possible. On the otherhand there is the knowledge that increasing defects in the detection ofproblems by Quality Units have actually occurred.

Whereasin the past the companies largely initiated their recalls themselves, thishas changed during the past two years. Over 60% of the recalls took placeonly after an FDA inspection. The head of the Manufacturing and ProductQuality department of the Office of Compliance, Joseph Famulare, urgesthat companies improve their quality assurance systems. For this reasonFDA will in future perform targeted inspections of the Quality Units.Famulare recommended that the companies assure themselves by means ofself-inspection that their Quality Units are functioning adequately.

Ina guide for inspectors FDA describes the background, the implementationand the focal areas of inspection of the new system.

Whereasin the past inspections were product-oriented, the focus has now shiftedto a general inspection. It is FDA's goal to reduce by means of this“new program” the extent and the depth of pre-approval inspections -depending on the experiences with the individual companies. FDA'sevaluation of the companies is computer-assisted.

Howare these new “system-related inspections” to be conducted?

Theywill take place according to a two-stage model. In Stage 1 the inspectorevaluates whether the QU fulfills its responsibilities as regards thereview procedures. In Stage 2 the documentation is evaluated in order todetect quality problems.

Inthis second stage the inspection will cover with respect to materialsystems in particular the handling of starting materials and finishedproducts, container closure and every water and gas quality which entersthe product or comes into contact with it. Other focal areas are thestocktaking and storekeeping and the distribution of medicinal products.

Inthe production area the focus will be on process validation. In thelaboratory area FDA will concentrate on analytical tests and thedevelopment of stability programs. With respect to buildings and equipmentthe focus will be on maintenance, calibration, IQ and OQ. In the area ofpackaging/labeling the main focus will be on preventing intermixing andthe handling of labels and on validation.

StefanieGray, former head of the Office of Compliance at FDA, has said of the newinspection system that it will enable the authority to react much morerapidly after the inspection and, since it gives a general view of thecompany as a whole, will also have a greater influence on marketingauthorizations. As an example S. Gray mentioned a company that receivedits warning letter already one (!) week after the FDA inspection accordingto the new inspection system.

Areyou looking for informationabout the defects most frequently complained about by FDA? The GOLD SHEETreports that the most frequent complaints in warning letters concernprocess validation and out-of-specification results (OOS).

Literature:TheGold Sheet, Vol. 35, No 4, April 2001

PS.For more information about Quality Units in comparison with qualityassurance and quality control we highly recommend the article by Rudolf H.Völler, Pharm. Ind. 59, No. 3 , pp. 243 ff. (1997).

Author:Sven Pommeranz, Project Manager, CONCEPT HEIDELBERG


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