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March 29, 2016

My homecoming to the world of pharmaceutical was eventful – full of opportunities to acquire new knowledge, and manifest it into my job. Among other skills and competencies, topping the learning chart is a realization that of risk management being close to the heart of a pharma organization.

Lets explore why risk management is paramount in pharma, and how pharma companies can strike a balance between risk management and compliance.

Computer systems validation (CSV) and testing are interchangeably used in pharm QA terminology. Essentially, QA for pharma aims at rigorous testing and documentation of every computer system that touches the drug development lifecycle from discovery to trials, including the entire downstream process of manufacturing, warehousing, and distribution. Plus, in line with GxP principles, evidence of desired system behavior must be proved through audit trails. And it doesnt end here. Data records must be archived for an agreed retention period, and produced for on-demand inspection by regulatory authorities. All this may sound similar to the testing and compliance functions of other industries. But in pharma, non-compliance can be critical and crucial.

Lets look at an example.

In its 10-12 year journey from the research lab to the market, a drug typically costs, approximately US$1-2 billion to produce. Once approved for production by regulatory authorities, often based on the submission of the New Drug Application (NDA), the drug is immediately accessible to a large population through healthcare providers. But the trials do not stop with the NDA. Post marketing surveillance, also known as Phase 4 of trial (aka Safety Surveillance or Pharmacovigilance), could detect rare or long term adverse effects of a drug consumed by a large patient population. The adverse effect necessitates drug recall. The spiral of inspections mandate reporting of all system records across the research, trail, production and distribution phases to the FDA. Non-compliance could result in severe penalties and repercussions – companies can ill afford such consequences.

The Writing is on the Wall

The writing on the wall is clear – adopting good clinical, laboratory, manufacturing and documentation practices is a must and not an option. As suggested in an earlier blog, Right First Time (RFT) is the mantra for success in the pharmaceutical domain.

Standard Operating Procedures (SOPs), well-defined QA roles and responsibilities, manufacturing controls, internal inspections, regular audits, efficient reporting, and prompt non-conformance investigations are some good practices, for preventing that dreaded FDA notice. The FDA notice, for sure, negatively impacts staff morale and also investor sentiment. Reacting to FDA notices, shares of large pharma businesses have taken a beating, touching all-time lows, and eroding market capitalization and shareholder wealth – a not so good situation for any company to be in.

In my next post, I will focus on patient safety, reliability, and data integrity, and explain why a culture of inhibition within the IT organizations of pharma companies prohibits the adoption of new technology, tools and techniques. We will also discuss a few really good or best practices from pharmas repertoire of good practices.

Satya is a Quality Assurance Consultant at TCS' Assurance Services Unit. He has handled various roles including IT Program Management, IT Delivery Management, Consulting and Business Development. Over the years he has helped customers, across the major markets, to set up Test Models and develop an Assurance Strategy for Large Programs. He is passionate about the world of Quality, Design, Art and Pharma. He holds a Post Graduate Program in Management from Great Lakes Institute of Management, Chennai.


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