Global Insight

Ashvin Mistry – Validation Consultant

Please describe your role at Contamac.

I’ve been working with Contamac since 2015. The first project I was given was to develop and implement a new validation and risk management system as part of the move to a new state of the art facility within Saffron Walden. This involved working closely with the quality and operations teams, qualifying critical production equipment and validating manufacturing processes as part of the transition to the new site. This was also in conjunction with changing the more traditional departmental hazard and operability study (HAZOP) style assessments over to a more comprehensive process style Failure Mode Effect Analysis (FMEA) assessments. I have subsequently become involved with revalidations and software validation projects for Contamac.

What is your professional history?

I have a degree in Applied Biology from Liverpool John Moore’s University. Briefly working as a microbiologist out of university before moving into a quality control (QC) analytical role within the pharmaceutical sector. From where I moved into more validation focused roles largely for the heavily regulated pharma and healthcare sector. Performing risk focused equipment qualifications and process and facility validations to the requirements of Good Manufacturing Practice (GMP), ISO13485 and ISO9001 for over 10 years. I’ve worked for the likes of Eli Lilly, Baxter, 3M, Pepsi, DHL, Thermo Fisher and the NHS prior to Contamac.

What do you enjoy most about working at Contamac and our industry?

The people and their continuing support and being able to make a real difference to the way that systems operate within the company. Ideas and actions can be implemented with relative speed and therefore systems can be quickly changed and improved. The flexibility of the teams, people are willing to wear several different hats and take on responsibilities outside of their formal jobs to ensure the success of the business.

What benefits does our move to SAP have on the business, its processes and in turn our customers?

One of the major changes Contamac will be undertaking in the next 12 months, is the roll out of a new Enterprise Resource Planning (ERP) system SAP Business One. A platform that will be used to manage most of the business-critical functions such as finance, sales and operations. The aim of this new platform is to drive continuous improvement and enhance the quality assurance functions for the business long-term.  It demonstrates a significant investment from Contamac both financial and in terms of people’s time and is testament to its continuing drive to streamline and improve service delivery. Making operations more transparent and improve the trackability, forecasting and delivery of products.

Can you put your validation work into context?

The industry is under increasing pressures due to significant changes in the ISO13485 and the new Medical Device Regulations (MDR), which in-turn have led to a higher set of standards to comply with and ever more stringent and demanding audits.  In my opinion, there seems to be more alignment with the requirements and standards pharmaceuticals have been subject to and we may well find that even higher expectations are set as new regulations come into force. A part of these requirements is the need to demonstrate that a manufacturer’s production and quality systems are in a state of control. Which not only includes equipment and processes, but software as well, where more emphasis is being focused on by the notified bodies and competent authorities. Properly planned and documented tests and challenges will show that systems are capable of delivering, given variations in operations. Therefore they are deemed validated and fit for purpose. Decisions on the scope and extent of qualification and validation activities should be based on a justified and documented risk assessment.