Displaying 1–25 of 58 results for Ali Afnan
FDAs Office of Product Quality needs a change agent. Ali Afnan has a suggestion.
International Pharmaceutical Federation honors Dr. Ali Afnan for his contribution to global pharmaceutical industry
Why are we so comfortable following draft guidanceFDAs unfinished and incomplete current thinking?
The idea that the product is the process and the process is the product can either result in sameness, or true control.
When it comes to QbD, we keep using that word, but does it mean what we think it means?
Standard work definitions, and recognized standards, will improve drug manufacturingnot nostalgia, or the insistence that pharma is different.
Wishing wont move pharma from a tribal to a diverse, crossfunctional culture.
Changing from the status quo to meaningful testing will satisfy both FDA and ASTM.
Effective change must improve business performance, and not just a process.
Process knowledge demands a very different approach to sampling.
Is an overly rigid FDA causing today's chronic drug shortages? Or is it an industry that still struggles to meet the most basic quality standards?
As its auto industry has done, Japan pharma may demonstrate that a cheaper manufacturing base is not necessarily the solution to our problems.
Three-to-four-month flu vaccine manufacturing cycles are within reach.
FDAs new guidance on process validation gets back to the original language of the GMPs on the subjects of control and sampling, Ali Afnan writes. After all, FDA never intended for three consecutive batches to satisfy either the spirit or the letter of the law.
It will add to the complexity and cost of compliance, in the short term, says one of the guidance's authors, but will offer tremendous savings in the cost of quality, time to market, cost of stockpiled product, and cost of filing process revisions with FDA.
Using physical material attributes allows for much tighter control of processes and product quality. Could a new excipient database be a model for pharma?
Before arguing about Just in Time (JIT) solutions and how to define them, shouldnt we look at why we need them, and form a plan?
The annual spring tradeshow has reenergized itself by building a year-round online presence.
New paradigms are needed if PATs promise is to be realized for biopharma process control.
Saving money through outsourcing is really starting to cost us.
Could closer study of Lean performance, supplement approval, and GMP oversight reveal correlations and drive holistic innovation, and cultural change?