Evaluation of blend uniformity and content uniformity based on 2003 stratified sampling guidance and 1999 Blend Uniformity Analysis Guidance: Product A

PDA Journal of Pharmaceutical Science and Technology

Volumn 58, Issue 4, 2004, Pages 222-230

  Howard Sparks, Michelle ^a   Gawlikowski, Andrew ^a  

^a Endo Pharmaceuticals   (United States)

Author keywords

Adequacy of mix; Batch uniformity; Blend uniformity; BUWG; Guidance; PQRI; Stratified sampling

Indexed keywords

GENERIC DRUG;

1999 BLEND UNIFORMITY ANALYSIS GUIDANCE; 2003 STRATIFIED SAMPLING GUIDANCE; ADEQUACY OF MIX; ARTICLE; BATCH PROCESS; BATCH UNIFORMITY; BLEND UNIFORMITY; BLEND UNIFORMITY WORKING GROUP; CONTENT UNIFORMITY; DOSAGE UNIT UNIFORMITY; DRAFT ABBREVIATED NEW DRUG APPLICATION GUIDANCE FOR INDUSTRY; DRUG APPROVAL; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG MIXTURE; DRUG QUALITY; FOOD AND DRUG ADMINISTRATION; ORGANIZATION; PRACTICE GUIDELINE; PRODUCT QUALITY RESEARCH INSTITUTE; QUALITY CONTROL; SAMPLING; STANDARD; STRATIFIED SAMPLING;

CAPSULES; CHEMISTRY, PHARMACEUTICAL; DRUG APPROVAL; DRUG INDUSTRY; PHARMACEUTICAL PREPARATIONS; PHARMACOPOEIAS; POWDERS; QUALITY CONTROL; SOCIETIES, PHARMACEUTICAL; TABLETS; TIME FACTORS;

EID: 3943050714     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (4)

1. Guidance for Industry. ANDA's: Blend Uniformity Analysis. Rockville, MD: United States Pharmacopeial Convention, Inc., 1999.
2. Final PQRI Blend Uniformity Working Group Recommendation to FDA. The Use of Stratified Sampling of Blend and Dosage Units to Demonstrate Adequacy of Mix for Powder Blends. Arlington, Virginia: Product Quality Research Institute, 2002.
3. Boehm, G.; Clark, J.; Dietrick, J.: Foust, L.: Garcia, T.: Gavini, M.: Geoffroy, J.M.: Jimenez, P.: Mergen, G.: Muzzio, F.: Planchard, J.: Prescott, J.: Tmmermans, J.: Takiar, N.: Whiteman, D.: Results of Statistical Analysis of Blend and Dosage Uniformity Data Obtained from the Product Quality Research Institute Blend Uniformity Working Group Data-Mining Effort. PDA J. Pharm. Sci. Technol. 58:2, 62-74 (2004).
4. Guidance to Industry. Powder Blends and Finished Dosage Units-Stratified In-Process Dosage Unit Sampling and Assessment. Rockville, MD: Federal Register, 2003.