This discussion addresses the application of the lifecycle approach to cleaning validation. It is intended to help in the development of compliant, effective, and efficient Cleaning Validation processes and programs following a structured lifecycle approach.
by Parveen Bhandola
“Lifecycle Approach Application to Cleaning Validation”
GXP Journal (Institute of Validation Technology), Volume 19, Issue 4, (November 2015)
Article on managing change and overcoming employee resistance and fear requires a proactive approach.
by Parveen Bhandola, Ph.D.
“Leveraging Change for Continuous Process Improvement”
Pharmaceutical Technology, 39 (10), (October 2015)
Ø Tablets and Capsules, Volume 10, Number 7 (October 2012)
Cleaning validation is a legally enforceable regulatory requirement that often draws investigators' attention during FDA inspections. This article, which focuses on manual cleaning of non-sterile solid dosage processes, describes how to approach Cleaning Validation to prevent cross-contamination.
Process design is the key to effective validation
By Parveen Bhandola, Ph.D.
Pharmaceutical Manufacturing, Sep 05, 2012
Validating any Pharmaceutical manufacturing process is a legally enforceable regulatory requirement required by current good manufacturing practices (cGMP) to ensure that drug products are made with the highest possible assurance that all quality attributes are met.
Validation establishes scientific evidence by collecting and evaluating data, to provide assurance that a process is capable of consistently delivering Quality products within the commercial manufacturing conditions.
Increasing globalization has constantly been making businesses more and more competitive. Consequently, the role of various Quality improvement programs has become increasingly crucial for any business to maintain its competitive edge. There is a growing need to continuously improve the Quality of products and services by utilizing the well-established Quality systems.
According to the well-known US Quality expert W Edwards Deming, who taught the Japanese the concepts of statistical Quality control, 85% of Quality problems are due to the systems and only 15% are due to employees. Therefore, the importance of Quality systems can not be over-emphasized. Since problem solving is a key element of the most Quality improvement programs, it is extremely important to fully understand the significance of solving the problems effectively.
Click below to see the article in Quality Matters, Winter 2010