Pqri guidelines for stratified sampling

Alternate approaches used for the non-pharmacopeial testing of content uniformity include the sampling of in-process materials (such as powder blends) ( Garcia et al., 2001; Muzzio et al., 2003, 1997 ) and the analysis of individual dosage units taken from the outlet of the tablet press or encapsulator in a systematic manner over the entire In August 1999 the FDA issued a Draft Abbreviated New Drug Application (ANDA) Guidance for Industry titled "ANDA's: Blend Uniformity Analysis" that detailed blend uniformity sampling and acceptance criteria for the determination of final blend uniformity for generic drug products. Although this guidance was written specifically to address ANDA's, the guidance was also adopted as standard In March 2002, the Product Quality Research Institute (PQRI) issued a proposal to the FDA with respect to both ANDA's and NDA's recommending the use of stratified sampling for final blend and in the recommendation, "the use of stratified sampling of blend and dosage units to demonstrate adequacy of mix for powder blends," represents an extensive effort by pqri's blend uniformity working Analysis and evaluation of the results of stratified in-process dosage unit samples shall be done as given below. Assay at least 3 of the 7 dosage units from each location. RSD of all individual results shall be ≤ 6.0%. ( for each batch n=60) Each location means shall be with in 90.0-110.0% of target potency. The fda supports their operational use sops, stratified sampling fda guidance documents that describeach principal component analysis during compression forces icrease in those drug product quality Blend uniformity guidance withdrawn May 6 due to "scientific issues relating to the scope of the guidance and methodology for blend uniformity analysis in general," FDA said. Product Quality Research Institute's stratified sampling approach was endorsed by FDA's Pharmaceutical Science Advisory Committee (1"The Pink Sheet" May 13, p. 25). FDA will issue a revised guidance following evaluation The FDA recommends the use of stratified sampling plans when the batch contains locations that may have dif- ferent results for a measured quality characteristic. The ex- pectation is for the product quality to be consistent through- out the entire batch with no significant differences existing between locations. PQRI submitted the following recommendation to the FDA on December 31, 2002, providing the Agency with an alternative strategy to consider when drafting future regulatory policy to assess blend and dosage unit uniformity. The Use of Stratefied Sampling of Blend and Dosage Units to Demonstrate Adequacy of Mix for Powder Blends 1. Garth Boehm Based on a PQRI recommendation, FDA published in 2003 the Draft Guidance "Powder Blends and Finished Dosage Units - Stratified In-Process Dosage Unit Sampling and Assessment". This document described stratified sampling as method for the validation of the blend uniformity and proposed a sampling plan for final product testing. The PQRI approach was adopted in the FDA, Draft Guidance for Industry: Powder Blends and Finished Dosage Units - Stratified In-Process Dosage Unit Sampling and Assessment of October 2003. The sampling recommendations in this guidance are based on this document. Refer to Appendix C for validation sampling guidelines and flow chart. Implementing a risk-based method can help companies spend less time and