As custodians to ensure patient safety, quality teams in pharma firms must have a mechanism not only to comply but to consistently comply, says Rashida Najmi, Senior Vice President, Global Quality, Regulatory, Pharmacovigilance and Patents, Piramal Enterprises. For this to happen, compliance to quality needs to become part of the culture of a company
Dear friends in the pharmaceutical space. Having spent more than 30 years in pharma quality, through this publication I aim to create a general awareness on quality culture. I fully recognise that the content in this article is based on my views and there can be an alternate or contradictory view which may be equally valid. Often times in various events and conferences that I attend outside pharma quality, it makes me ponder about the fast pace at which several other high risk industries (like automobile, aerospace, banking etc) have grown leaving pharma to be viewed as a snail in bringing innovation to market. The time to market for any pharma discovery is on an average 12.5 years with the cost of over £1 billion. There is also high degree of molecule attrition as the journey progresses on the drug development life cycle.
Why does pharma take a conservative approach?
There is a reason behind such a conventional approach to drug development and licensing process. The most significant reason is delayed knowledge of its adverse outcome and low possibility of its retraction once consumed. Unlike faulty cars, air planes, etc. which can be possibly recalled, drugs once administered cannot be retrieved back from the patient’s body. Similarly, while risk to human life due to faulty cars and jet planes can be as huge, the risk is known immediately if it crashes. In the case of medicines, the risks could be evident after several years, decades or generations. These are the factors that make pharma researchers and regulators take a conservative approach.
The pharma sector has also learnt certain lessons the hard way. For e.g. the Thalidomide tragedy in 1962, developed in 1950, the drug Thalidomide was licensed in 1956 as an over-the-counter medicine in Germany. This anticonvulsant medicine also had a mild tranquiliser effect. The animal tests did not challenge the drug for use in pregnancy. Due to good effect of the drug in morning sickness, it became popular among pregnant women. It is only after 1962 that 10,000 children were born worldwide with Thalidomide- related disabilities. Though very effective in some conditions, the medicine has since then remained a very controversial drug. The reason to build this premise is to bring in an awareness of what type of industry we are in. Billions of people worldwide trust us while taking medicines for themselves or their beloved, believing that everything in it is as expected. This is why I often tell my quality team, “If you do not trust that a product you release can be consumed by your child and/or beloved, you should not release it.”
Doing it right every time
As pharma quality professionals, we closely keep track of all published and upcoming regulations. We align our systems as new regulations come to force from time to time. I agree this is required and should be done, but more important is not to do it merely because it is a regulation but understand the reason behind the regulation and then do it right. If we do it right every time, it would comply with regulation any ways. So, as a custodian to ensure patient safety, quality teams in pharma firms must have a mechanism not only to comply but to consistently comply. This happens when compliance is a culture in the company. Quality as a culture needs constant efforts and a cultural shift in organisations. It is important to have a methodical mechanism to achieve this. It is not possible to include the whole mechanism within a few paragraphs. However let me provide few insights that could help.
First, assess the level of compliance
Needless to say, quality as a culture starts from the leadership level. Once this is understood clearly, it is important to have the right quality leadership – a knowledgeable and competent quality team is a strong pillar and a key driver to pharma business. It is also important to have optimal resources to support quality activities (I want to warn here ‘more is not better’. It should be adequate). Before we go to culture, the first step is a mechanism to proactively assess the level of compliance on the significant quality factors. You cannot work on a culture if your platform of compliance is labile. So have a mechanism to periodically assess these. For example, closure rate on aberration, timely completion of APQR, timely compliance on CAPAs, effective validation of CAPA, controlling invalidated OOS, control over repeat deviations and quality events including product complaints, robustness of investigation (make sure majority of your investigations are not merely closed by imparting training as a corrective. It will not work), timely and effective closure of lab investigations, timely and effective closure of stability samples, timely and effective closure of all audit commitment, timely revision of SOPs, timely closure of qualification, calibration and validation, compliance to data integrity etc. I have observed that these compliance factors often take a back seat under pressure to make sure that batches are released. Often the team from compliance is diverted to releasing the batches. Firms that have an operation and system quality dedicated silos sometimes are better placed in this situation as resources are dedicated.
Fortification of the quality process
A periodic quality council to review the above compliance platform and its health helps in not losing focus. Upon arriving at the base level, it is preferred to set a target which is higher. When this shows a healthy trend month on month, it is time to look at its fortification. This is the time to then look at some improvement areas such as internal audit effectiveness, reducing number of review cycles, right first time and error reduction, reducing cost and time of repeats, simplification of forms (visual management), reducing cost of reject/rework/reprocess, effective training (not just logging training hours). This will also be a good time to embark or enhance automated quality system. Review mechanism to keep an eye on these improvement will be important.
Putting in place a governance mechanism
When both the above processes go on autopilot mode, a phase to lay down a long-term strategic quality roadmap will be a good idea. This should take into consideration both regulatory and business requirement. At this stage putting a governance mechanism to execute, handle escalation and review will be imperative. The roadmap needs to be dynamic and should be revalidated from time to time. People form an important pillar to quality culture. It is important to create a culture of honest reporting, transparent dialogue and have an appetite to face failures. You need only one ‘not good’ person to impact your quality culture journey, so it is important to onboard every one and take their buy in and then on, hire the right people when you need to hire. Once these cultural pulleys move, it automatically resonates into a highly compliant company. Any hindrance in their movement is evident due to a healthy culture of empowerment on the shop floor and quick reporting. I wish you the best of luck as you embark on your quality culture journey!
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