STUDIES IN PROSPECTIVE PROCESS VALIDATION OF ALLOPURINOL USP AS ACTIVE PHARMACEUTICAL INGREDIENT-Reference-Cited by-同舟云学术

STUDIES IN PROSPECTIVE PROCESS VALIDATION OF ALLOPURINOL USP AS ACTIVE PHARMACEUTICAL INGREDIENT

Published:2021-12-16 Issue:10 Volume:58 Page:42-50
ISSN:0019-462X
Container-title:INDIAN DRUGS
language:en
Short-container-title:IND. DRU.

Author:

Kandle Hemant S.,Patil Sangram S.,Sawant Sujata S.,Vambhurkar Ganesh B.,Jagtap Asha M.,Gavade Akshata S.,Bhutkar Mangesh A.,

Abstract

Allopurinol USP batches of same size, method, equipment and validation criterion were taken. The critical process parameter involved were reaction, drying, milling, sifting, milling, and blending stages were validation. Quality cannot be assured by daily quality control testing because of the limitations of statistical samples, and the limited facilities of finished product testing. Validation checks the accuracy and reliability of process. Aim of this work was to study prospective process validation of allopurinol USP designed to meet the current regulatory requirements and prove with assurance that the product meets the predetermined specifications and quality attributes. The critical process parameter was identified with the help of process capability and evaluated by challenging its in house and compendial specification. Three initial process validations batches APL/008, APL/009 and APL/010 were identified and evaluated as per validation master plan. The outcome indicated that this process validation data provides high degree of assurance so that manufacturing process produces a quality product.

Publisher

Indian Drug Manufacturers' Association (IDMA)

Subject

Drug Discovery,Pharmaceutical Science,Pharmacology

Reference9 articles.

1. 1. USFDA Guidance for Industry Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002.

2. 2. Nash R. A., Pharmaceutical Process Validation, Marcel Dekker, New -York, 2003(57) pp 17-23.

3. 3. Division of Manufacturing and Product Quality (HFN-320) Center for Drugs and Biologics Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857, FDA Guidelines on General Principles of Process Validation, available at https://variation.com/fda-process-validation-guidance-1987-pdf/.

4. 4. Guidelines on Process Validation, the European Agency for the Evaluation of Medicinal Products, available at https://www.ema. March 2012.eu/en/documents/scientific-guideline-process-validation-revision-1_en.pdf.

5. 5. Roger W. Koops.: Process Validation of Synthetic Chemical Processes for the Production of Active Pharmaceutical Ingredients, Journal of VALDN Technology, 2002, 8: 1-14.