SM Mudda, Chairman, Regulatory Affairs Committee, IDMA and Director – Global Strategy (Technical), Micro Labs, emphasises the need to adopt a Quality Management Systems (QMS)-based approach to provide quality medicines
Revisiting the question posed in my article ‘Pharmaceutical quality and compliance: Has the ‘elephant in the boardroom’ been recognised’ in Express Pharma GMP special issue of May 2016, it appears that we have embarked on the quality journey and the industry seems to have corrected its skewed perception related to GMPs. It has recognised the need to go beyond mere ticking the boxes for demonstrating compliance with minimum regulatory standards to adopting a Quality Management Systems (QMS)-based approach and positioning quality as a management function for providing high quality medicines.
A myriad of initiatives have been started by the industry and associations that demonstrate a paradigm shift in the approach towards quality and compliance. The focus clearly seems to be on skill upgradation and capacity building. The IPA Quality Forum is working tobring the large companies together to address quality issues and to jointly develop solutions based on global best practices with a view to help Indian pharma manufacturers to achieve global benchmark in quality. Similarly, the Department of Pharmaceutical (DoP), Ministry of Chemicals & Fertilizers has initiated a nation-wide GMP training programme in partnership with IDMA for helping the industry to voluntarily upgrade GMP standards to current global standards. One of the major policy initiatives of Government of India of recent times has been the Prime Minister’s Skill India initiative implemented through Life Sciences Sector Skill Development Council (LSSSDC) in pharma industry.
Despite these initiatives, the industry still confronts operational challenges for ensuring ongoing GMP compliance and in implementing successful remediation measures. The common factor in both the cases seems to be lack of adequate skills of personnel in these functions as seen from the observations below.
Consistently inconsistent GMP Compliance – A recurring issue
Having seen the welcome shift in focus by the industry to make skill development and knowledge management as key enablers for quality excellence, one would have expected companies to achieve a state of sustainable compliance.
However, a look at the regulatory actions of the last year and inspection findings point towards the operational challenges the industry is still facing to remain in a state of compliance. While companies heaved a sigh of relief if no data integrity issues were observed during the inspections of the types seen in the previous years, when challenged on what actions were taken by the companies when things went wrong, companies seem to wrestle in meeting the regulatory expectations.
The recent examples of Warning Letters issued for not addressing the perennial issues of recurring product complaints adequately for years, underestimating the risk to patient safety and releasing batches with inadequate Corrective and Preventive Actions (CAPAs) or another one related to invalidating a high number of Out of Specification (OOS) results, again without identifying the causes of OOS results, indicate a clear lack of capabilities of the operating personnel and reviewers.
Many examples of failure investigations with particular reference to complaints, batch rejections, deviations and out-of-specification results revealed companies building arguments in favour of release of batches rather than identifying the root causes and implementing preventive actions, often due to lack of understanding, ability and occasionally due to lack of commitment. All these failures indicate a QMS that is insufficiently empowered and is not resourced adequately with employees possessing the required skills and capabilities of investigating the failures by adopting a science and risk-based approach.
Underinvestment in talent development during remediation
While the challenges for GMP compliance are attributed to inadequate capabilities of key personnel, it has also been one of the major contributing factors for remediation failures. The recurring failures of compliance, despite comprehensive remediation plans implemented point towards correcting the interacting parts (individual functions) of a QMS in isolation rather than building it. Deming’s System of Profound Knowledge (See Fig 1) teaches us to appreciate the organisation as a system-seeing and leading it as a system and not causing people in different departments to compete for attention and resources. System is a product of interacting parts. Improving the parts taken separately will not improve the system. It appears that in the remediation phase, the QMS is developed in response to GMP failures and is focussed only on implementing immediate quick-fix measures for short-term gains. The measures of improvements implemented through a weak QMS or outside of QMS do not integrate the CAPAs in the QMS and hence can’t sustain the benefits of remediation. During this phase, focus is not given on building an appropriate quality organisation with competent key personnel suitable for the size of the organisation and complexity of the operations.
The remediation activities are seen to be executed by the team of consultants at the expense of developing local quality leadership. There has been an under investment in the talent needed to upgrade the quality system once the company emerges from the remediation.
Connecting the three dots- GMP, quality system and culture of quality
The examples of GMP and remediation failures suggest that the power of quality system as a foundation in creating a sustainable culture of quality has not been fully realised and QMS is not yet regarded as the philosophy behind the practices and a key driving force for compliance. The development of a QMS that is lean, simple and agile, connecting it to GMPs and using it as a foundation to foster a culture of quality is going to be possible only when the organisations develop second-level leadership for quality (See Fig 2).
It is clear that the only way forward for a sustainable compliance is education of the key personnel in the organisations whose actions will be consistent with the top management’s quality intent (policy) in letter and spirit and they will have a capability to convert the intent to concrete action plan for implementation. This view has been confirmed through various surveys conducted by consulting firms like Ernst & Young and others.
A long-term education programme and not training will be a strategic investment in prevention of non-conformances.
IDMA initiative in skill development
IDMA understands that in the wake of ever increasing regulatory bar, expectations from technical and QA professionals who represent the company for demonstrating an ongoing compliance with GMPs have increased. Lack of structured formal education of these senior practicing technical/ QA professionals in the concepts of quality management is identified as one of the key factors for failures that requires immediate remediation.
Indian Drug Manufacturers’ Association (IDMA) in collaboration with UK-based NSF Health Sciences (formerly known as David Begg Associates) therefore has launched a customised intensive education and skill development programme ‘Advanced Program in Pharmaceutical Quality Management ‘(APPQM) targeted at Pharma Technical and Quality Assurance Professionals. This education programme that is created after a careful study of the issues faced by the industry with the expert team of NSF, UK over a period of the last two years, will help build the strength of the quality professionals across the industry with a formal certificate of international standards and an ability to match the global professionals.
The initiative is the latest in a series of endeavours by IDMA to re-skill senior pharma professionals, in response to the prolonged regulatory woes being faced by some companies in India, stemming from poor GMP compliance. The IDMA initiative is consistent with the objectives of the Prime Minister’s Skill India initiative implemented through LSSSDC. In fact, IDMA is one of the stake holders in the LSSSDC governing body. The qualification packs developed by LSSSDC provide the Occupational Standards for various functions including quality management. The standards presently are aimed at building the basic capabilities in each function and apply mostly to operating level employees.
IDMA – NSF: An unique collaboration
NSF International UK is a global leader in education for the pharma industry. IDMA has selected NSF because it has knowledge of the India pharma industry and over 40 years of global experience with offices in India, the US, China, the EU and the UK. Its team of experts includes Martin Lush, Global Vice President, NSF Health Sciences, UK, Robert Hughes, John Johnson, Chris Harris, Dr Peter Gough and Bruce Davis and includes ex regulators (MHRA & FDA) and seasoned professionals with 35 years plus hands on experience. Some of the tutors have been involved in writing key industry standards including ICH Q8, 9, 10 and WHO, EP and USP standards.
Programme details and benefits
The APPQM is designed specifically for Indian companies who want to succeed in US and European markets. Designed both as an education and mentorship programme, the intense and challenging MBA style programme will provide participants education related to best industry practices in quality culture, quality management, regulatory compliance, manufacturing operations, leadership skills, skills in risk- based decision making, advanced problem solving, crisis management, simplification and lot more. Delegates will complete a written assessment for each module. Successful candidates will be awarded an internationally recognised certificate in PQM.
The course fee for a 30-40 batch, of approximately 8100 GBP + 15 per cent service tax plus actual travel and stay expenses is considerably lighter on the training budgets of pharma companies. This is considerably more economical, especially for smaller companies, who do not have the budgets to exclusively hire the faculty for 40 tutor days of in house training, which would come to around 150000 GBP compared to 10000 GBP for the entire programme.
Sessions will be highly interactive using problem based learning to change behaviours and improve performance.
The programme will be delivered in five intensive modules (See Fig 3). Each of four days duration scheduled every eight weeks. For ease and convenience modules will be presented in Bengaluru at the beautiful campus of Acharya College, Bengaluru.
Return on investment – Improved operational efficiency
Clients who have attended NSF programmes have generated $ millions in savings. For example: Reducing repeat deviations by 78 per cent in just six months, reducing ‘Human Error’ deviations by 67 per cent in 12 months, achieving 99 per cent ‘Right First Time’ at product release and achieving zero regulatory observations following audit.
Improving behaviours and ‘quality mind-set’
NSFs methods ensure that learning is taken out of the classroom and into the workplace. Behaviours will change and performance will improve. People stay when they know they are being developed.
Pre-launch of the programme
The pre-launch of APPQM was held at Bengaluru on February 12, Hyderabad on February 14 and Mumbai on February 16, 2017. The pre-launch was supported by DoP and FICCI at Bengaluru, PHARMEXCIL at Hyderabad and Fourrts (India) Laboratories and Micro Labs at Mumbai and was attended by more than 120 senior members of the pharma industry along with dignitaries from government and regulatory agency. The presence of senior government officials highlighted the importance and enhanced the value of this programme. Sudhansh Pant, Ministry of Chemicals and Fertilisers, Government of India, at Bengaluru, Uday Bhaskar, DG, Pharmexcil at Hyderabad and Sudhanshu Pandey, IAS, JS, Ministry of Commerce and Industry, Government of India, at Mumbai graced the events.
IDMA leadership team comprising board members, SM Mudda, Chairman, Regulatory Affairs Committee, IDMA and the Program Coordinator, lead by the National President Deepnath Roy Chowdhury and immediate Past National President, SV Veerramani, participated in the events. Omprakash Sadhwani, Joint Commissioner FDA, Maharashtra, Mumbai and Dr K Bangarurajan, Deputy Drugs Controller (I), CDSCO, West Zone Mumbai also applauded IDMA for this excellent initiative and for taking training to the next level.
IDMA has received 20 confirmations for registration and the seats are filling fast. The response from the companies is very encouraging and interestingly, apart from the technical and QA professionals, the next generation entrepreneurs have also come forward to join the programme. The programme also has received good support from the Qualified Persons (QPs) from UK who oversee the GMP compliance of the Indian sites supplying medicines to the UK and Europe. The first batch is starting tentatively from September 2017.
Medicines are only as good as the people involved in making them. It is said that ‘Quality is too important to be left to Quality Controllers alone’. Quality is in fact the responsibility of everyone. Thus, people in R&D, manufacturing, QA, QC and people from functions having direct or indirect impact on the quality of products including the Nextgen business leaders contribute in making the best products and it would only be appropriate that they are educated in the concepts of quality management.
We need to understand the difference between training and education. While training can develop skills required for performing tasks well (the how of a practice) education of the concepts behind the practices will develop the ability of people to make the practices consistent and sustainable (The Why of How).
The experience of remediation of the last few years has revealed that short-term training programmes do not help in changing behaviours. Similarly, transformation initiatives not supported by concrete action plans and management support do not yield desired results. As Deming exhorted, quality transformation launched by ceremonies with a speech by the governor, raising of flags, beating drum, badges, all with heavy applause, is a delusion and a snare. While such programmes can give an impression of progress being made, in reality unless supported by concrete actions the real benefits will elude us.
The answer for skill building lies in providing structured long term, on-going education platform to the industry. Such programmes alone will help in developing Change Agents for Quality Excellence and will make India the centre of excellence for pharma manufacture. The APPQM offered by NSF- IDMA is one such significant first step towards quality excellence and in building “BRAND INDIA”.