From compliance to culture
By Rashida Najmi, Sr VP Global Quality, Regulatory and Pharmacovigilance, Piramal Enterprises Ltd.
Dear friends in pharma 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 recognize 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 make 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 to market innovation. An average time to market for any pharma discovery it takes on an average 12.5 years with the cost of over 1 billion £. Also there is a high number of molecule attrition as the journey progresses on the development life cycle.
There is a reason behind such a conventional approach to drug development and licensing process. Most significant reason is delayed knowledge of its adverse outcome and low possibility of its retraction once consumed. Unlike faulty cars which can be possibly recalled, drugs once administered cannot be retrieved back from the patient’s body. Similarly while human life risk due to faulty car can be as huge, if it crashes the risk is known immediately. While in 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.
Pharma also have learnt certain lesson in a hard way, for eg Thalidomide tragedy in 1962. Developed in 1950 the drug Thalidomide was licensed in 1956 as over the counter medicine in Germany. This anticonvulsant medicine also had a mild tranquilizer effect. The animal tests did not challenge the drug for its use in pregnancy. Due to good effect of the drug in morning sickness, it became popular in pregnant women. It is only after 1962 that 10,000 children were born worldwide with Thalidomide related disabilities. Thalidomide though very effective in some of the conditions 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 are we into! Billions of people worldwide put trust on us while taking medicines for themselves or their beloved, believing that everything in it is as expected. This makes me say the most common phrase used by me for my quality team “if you do not trust that a product you release can be consumed by your child, you should not release it”.
As a pharma quality professional we closely keep track of all regulations published and upcoming. 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 the pharmaceutical 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 a constant effort and a cultural shift in organizations. It is important to have a methodical mechanism to go there.
It is not possible to include the whole mechanism within few paragraphs; however let me provide few insights that could help. Needless to say, Quality as a culture starts from the leadership level. Once this is understood clearly, important is to have a right quality leadership – a knowledgeable and competent quality team is a strong pillar and a key driver to pharma business. Also important is 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 eg., 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 often observed that these compliance factors often take a back seat in a 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.
A periodic quality council to review the above compliance platform and its health periodically 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 improvements will be important.
When both the above 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 need 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 buying in and then on to hire the right people when you need to hire.
Once these cultural pulleys move, it automatically resonate into highly compliant company. Any hindrance in their movement is evident due to healthy culture of shop floor empowerment and quick reporting. More later…
Good luck to embark on a culture journey. Feel free to write on firstname.lastname@example.org, if you have questions.
About the Author
Rashida Najmi is Sr VP Global Quality, Regulatory and Pharmacovigilance, at Piramal Enterprises Ltd. She leads the Quality globally for all Piramal sites in US, UK, EU, Canada, India, plus CMOs worldwide. She has been instrumental in setting up impeccable quality culture in her company. She has around 30 years of experience in pharmaceutical industry with 18 years in the leadership roles.