PQRI

The organization of PQRI is shown in Figure 5. A board of directors collects and allocates funds. A steering committee directs overall activities, and a series of technical committees work in five current priority areas drug substance, drug product, biopharmaceutics, science management, and novel... 

Fig. 5 Organization of the Product Quality Research Institute (PQRI).

U.S. Food and Drug Administration (FDA), Extra 6 Safety thresholds and best practices for extractables and leachables in orally inhaled and nasal drug products, PQRI Leachables and Extratables Working Group, available http //www.pqri.org/pdfs/ LE Recommendations to FDA 09-26-06.pdf. 

The different perspectives presented in this chapter were inspired by many discussions and debates (e.g., at the FDA, PQRI, the University of Maryland, and nu-... 

The SUPAC and other related regulatory guidance documents have, for the first time, provided an opportunity to reduce the regulatory constraints based on the pharmaceutical sciences. The FDA s participation in PQRI reflects its desire to enhance the scientific basis of its policies, thus creating numerous regulatory opportunities. It is hoped that the phannaceutical community wiU recognize these... 

The Use of Stratified Sampling of Blend and Dosage Units to Demonstrate Adequacy of Mix for Powder Blends, Blend Uniformity Working Group of Product Quality Research Institute (PQRI) available at PQRI Website (http //www. pqri.org). 

Larner G, Schoneker DR, Sheehan C, Uppoor R, Walsh P, Wiens R. 2006. PQRI survey of pharmaceutical excipient testing and control strategies used by excipient manufactures, excipient distributors, and drug-product manufactures. Pharm. Technol. 30(9) 90-98. 

Snorek S, et al. 2007. PQRI recommendations on particle-size analysis of drag substances used in orgal dosage forms. J. Pharm. Sci. 96(6) 1451-1467. 

What is the difference between Extractables and Leachables The following definitions are taken directly from PQRI [43]. 

PQRI Stratified Sampling Approach to Drug Uniformity, The Pink Sheet May 13... 

The FDA s Pharmaceutical Science Advisory Committee concluded at its May 8th, 2002 meeting that the PQRI recommendation for stratified sampling could be applied to routine production as well as bioequivalence and validation batches. The FDA will internally review the PQRI recommendations and send them any concerns or further suggestions. The results will form an FDA guidance on content rmiformity. ... 

If the FDA chooses to follow the stratified sampling recommendation of the PQRI, blend uniformity testing and the large problem of sampling may soon become history. Until then, however, guidelines should be followed at all times, awareness should be raised to minimize errors, and the importance of sampling should not be underestimated. Testing must be carried out frequently to ensure that each blend reaches the standards set. 

PQRI. Results of Statistical Analysis of Blend and Dosage Unit Content Uniformity Data Obtained from the PQRI BUWG Data-Mining Effort, http //www.pqri.org (accessed August 2002). 

FIGURE 15 Correlation between blend and tablet data. Source Courtesy of PQRI. 

The second database, the PQRI database, contains data for about 750 columns. The data for each column were determined by means of five chromatographic tests carried out at different pH values, so that with this database a very good comparison of stationary phase selectivity, also as a function of the mobile phase... 

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