Process validation is the only way to provide proof of product quality, stated speakers at the AICTE sponsored national seminar on Quality Assurance in Pharmaceuticals.
The two-day seminar organized by the Department of Quality Assurance, Acharya & BM Reddy College of Pharmacy held on July 18 and 19, 2011, in Bangalore highlighted that planned or systematic actions were necessary to provide adequate confidence that a product would satisfy the requirements for quality.
A panel speakers including A G Raghu, Head QA & RA, Apotex Pharmachem India Private Limited, R Raghu, senior director, Schrodinger stated that operational laboratory techniques were used to fulfill the requirement of quality. The audience included people from industry and pharmacy college students and teachers.
Quality Assurance is that part of Good Manufacturing Practices concerned with sampling, specification & testing, documentation and release procedures which ensure that the relevant tests are performed before the product is released for use, concurred pharma experts at the seminar.
According to Mahabubi S, Head, QA, Micro Labs Ltd, Quality Assurance was aimed at ensuring that products are consistently manufactured to a quality standard.
While the industry maintained quality control norms, there was also adequate need for trained workforce. “While there is a need to schedule validation once in every six months, there is also need for training of qualified personnel especially while working in an a septic area, stated Mahabubi in her presentation.
Experts in the industry stated that quality assurance is the sum total of organized arrangements made with the object of ensuring that product will be of a required standard by the intended user. A set of Standard Operating Procedures (SOPs) were mandated for both Quality Control and Quality Assurance. These included stability testing of new drug substances and new dosage forms apart from evaluation for stability data stability data package for registration applications in Climatic Zones III and IV along with validation of analytical procedures: which covered both Text and Methodology.
The seminar also had a poster session highlighting the varied steps of Quality Control and Quality Assurance.