1. How much has the level of quality in Pharma manufacturing improved in the last decade?
Quality has continued to improve in the pharma manufacturing arena; however, new challenges have been introduced. Increasing regulatory standards and rapid changes in technology & systems have driven increased complexity. Put in a backdrop of challenging economic times and rapid globalization, and many supply chains are significantly more complex today than in the past. These pressures have driven increased risk and more quality issues across all dose forms. Industry has been slow to react and effectively identify and manage these risks. While there have been improvements, common deficiencies and problems still remain unresolved. Poor risk management; inadequate deviation investigations and lack of process understanding and control remain common issues and continue to challenge the industry.
2. Where do you see the greatest progress in pharmaceutical manufacturing in terms of assuring the highest quality?
The advent of more sophisticated data collection and process monitoring has been a significant leap forward. Manufacturers are now blessed with large swathes of data about each manufacturing step, batch and process. This simultaneously poses a great advantage and a challenge. Less emphasis is typically placed in understanding of the data as much as acquisition of it. Process understanding is useless without data and likewise data is useless without process understanding. The introduction of QbD has done something to address this imbalance, however more work is needed.
3. How much needs to be done by the industry vs regulators to achieve a desired level of quality?
The industry assures quality; regulators set the guiding principles and rules. The purpose of a regulatory framework is to provide guiding principles and minimum standards, while stopping short of giving direct instruction. This can sometimes be misunderstood as “vague” or “poorly defined”, but poses a great opportunity for industry. Companies are free to define their own controls and technologies, innovate and lean existing controls. The ultimate responsibility to comply with the minimum standards & assure product quality/patient safety remains with the industry. Regulators ultimately have a supervisory and regulatory role – supporting industry, providing oversight and updating the “rules”. It’s important that those within the industry maintain trust and demonstrate they can robustly ensure quality, otherwise regulators will be pressured to tighten the rules.
4. How would you evaluate the number of quality incidents and their severity in the last two years? Could you please give us few examples of the most common quality incidents you have observed?
The number of severe deficiencies has risen over the last few years. Some of this has been attributed to a new take on old problems – “Data Integrity” being a good example. Much has been the same old problems, for example: sterility assurance issues, quality system failures, cross-contamination, etc. Most have a common theme – poor risk management and control. Risk management is a mindset and the industry hasn’t done enough to foster it in their people.
5. What seems to be the most sensitive part of assuring quality in Pharma manufacturing? What would be your tips to handle these challenges?
Quality is dependent on people and there has been a distinct shift in industry related to people, skills and knowledge. Whether it be financial challenge, lack of available skills or conflicting priorities, in many cases, industry has forsaken the development of people, skills and mindset. Too much emphasis has been placed on technology, processes and procedures. Training is just the start – increased emphasis needs to be placed on development of staff & knowledge management. Organizations need to be able to effectively mentor their staff, retain key knowledge and ensure effective mentorship to foster a new generation of critical thinkers.
6. Could you please describe 1 – 2 examples of industry best practices on how to prepare for a GMP inspection?
Good inspection management is key. Be clear on the process and the responsibilities. Introduce a good request management and hosting procedure. Lead your own inspection – don’t let the inspector. Trust in your subject matter experts. Most inspectorates relish a technical discussion – don’t be afraid to defend your position if it is sound.