“Act as if every day is an audit”

Dr Paranjape, as a veteran in the pharma sector, what are the main challenges faced by pharma companies in India which prevent them from achieving compliance with global norms?
It is not a matter of Indian or global compliance. Quality and compliance are ethics, duty and social responsibilities. Non-compliances are harmful to the health of any patient or consumer of the drug whether he/she is Indian or global.

The challenges faced by pharma companies are of different types. For start-ups, it might be different, like financial, availability of the funds, getting talented, knowledgeable people with the right mindset in the range of the salary they want to provide, retention of talent, making their facilities cGMP compliant within their budget constraints, availability of the resources, getting business, generating revenue to sustain all the expenses required to comply the cGMP, 21 CFR guidance and many others.

For established firms, they may be different. In established firms or companies, there is knowledge, talented people, facilities and resources, but the challenge is to maintain the standard of zero 483s or compliance with the guidance 21CFR or other regulatory standards. Maintaining consistency in compliance is a challenge. Maintaining the standard obtained during the inspection is a challenge.

When a product is launched in the market, handling market complaints and product recall are the challenges. The complaints may be related to quality, adverse events, retailer complaints and many more.

Identifying the accurate root cause to minimise challenges, performing risk assessment for critical cases, or, as per guidance, is necessary.

I have discussed the reasons for non-compliance in the third chapter of my book “Blue Ocean of Compliance.” These are the reasons applicable all around the globe.

In chapter four, I have discussed the actions to be taken for non-compliances discussed in chapter three. I would recommend reading the book multiple times to stop non-compliances on one’s site.

What inspired you to write “Blue Ocean of Compliance”, and how does it try to address these challenges?
When I look back at the audits I have experienced, I think to myself: instead of operating out of fear or a scared mindset, why don’t we operate with a winning attitude and confidence? I think we should change our thinking patterns and work to win, instead of “not to lose.” We have to win; we have to work for the outcome of the audit with “no observation.” We have to prepare for the audit every day, we must act as if there will be an audit every day instead of preparing when the time comes.

While these thoughts of pain and gain were going on, the idea of this concept came into my mind, to help pharma industries develop a winning strategy to face the audit.

The concept behind writing this book is to give a new angle to look at the regulatory inspections, and to help solve the problem of non-compliances on the site.

How is it different from previous books on this subject?
This book is written by an analyst, a regulatory person who has prepared and submitted DMF, dossiers and MAA; a compliance person, who has closely seen the manufacturing sites, and worked with blue-collar employees.

In other words, a doer who has worked on the shop floor and experienced the pain/challenges of people working on the shop floor. She has also worked with the management and now wants to
help the global pharma community to overcome the challenges of non-compliances, and share her learnings with the pharma world so that they become successful and grow in their business and job with less effort and cost.

I never referred to any book available in the market on this subject to write this book. This comes from my heart, and I am going to share it with the global pharma community to make them successful.

Who is the target audience for the book?
If you are working in the pharma industry in the cGMP environment, if you are working in quality assurance, or quality control or, production department, if you are part of the team that is responsible for audits, then this book is for you.

If you face customer audits, then this book is for you.

If you worry about audits and are looking for a better and more efficient approach, then this book is for you. If you are in R&D, then this book is also for you to expand the dimension of your thought process to support the cGMP department.

If you are a fresher who doesn’t know anything about audits, why audits happen, and how to prepare for audits, this book is for you.

If you are a CEO, President, Vice President, General Manager, Manager of any pharma company, and want to ensure that your organisation passes regulatory audits with no observation, this book is for you.

If you are a CEO or founder of a pharma company, and you want a brand that everyone trusts, this book is for you.

If you are any of these, and you want to know what are the practices that one should and shouldn’t follow, then this book is for you.

In this book, I have covered many of the wrong practices which led international pharma companies on the path of getting enforcement actions warning letters and 483s.

This book has been written to help all the people working in the pharma industry, those who are a part of regulatory inspections, business owners of pharma organisations, founders and CEOs, as well as people working in the cGMP areas.

Regulatory inspections, disrupted due to the pandemic, have re-started recently. How do pharma companies gear up to avoid disruptions like warning letters, closures, etc?

If you look at warning letters, you will find there are several reasons why the investigator has issued a warning letter to the firm/s. They include issues like breach in integrity, falsification of data, alteration of data, misleading or false information, misrepresentation of facts, untruthful sentences, deceit, forgery, submission of false or inaccurate information to gain benefits or with intention to deceive, data manipulation, questionable information, misreporting or selective reporting, poor manufacturing practices, false product claims, or incorrect directions for use.

Once you read it, you may conclude that the warning letter has nothing to do with the pandemic. The agency’s policy is that warning letters are issued for violations that have regulatory significance. If adequate corrective actions aren’t taken promptly, enforcement actions are taken by the regulator.

To avoid any enforcement action, one has to follow cGxP and strictly say no to non-compliances and loss of data integrity.

Chapter two of the book is “Types of Regulatory Enforcement Actions and Regulatory Actions on Non-Compliances and Devastating effects for the Pharmaceutical Industry due to Non-compliance.”

I have discussed most of the types of enforcement actions taken by the US FDA regulatory authorities, why these are taken and many other facts and insights. A few of them are warning letters, injunction, prosecution, seizure, recall and field correction, alerting the public, effectiveness checks, recall classification, drug product debarments and notations, among many others.

What are the common risk-mitigation steps to avoid/prevent repeat non-compliances?

If non-compliances are repetitive, this means they are not properly investigated, and the actual root cause of deviations or Out of Specifications (OOS) was not identified. Hence, Corrective and Preventive Action (CAPA) is not effective. The result is that even after taking CAPA, non-compliances are repeated.

To prevent any non-compliances, deviations or OOS, they must be properly investigated so that the CAPA is effective and prevents the occurrence of the same problem. Quality Target Product Profile (QTPP), Critical Quality Attributes (CQA), Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs) need to be studied in depth. OOS should be investigated properly. It’s like, any disease will be cured only when we get the medicine that cures the root cause, and not just them symptoms.

Compliance must be 24x7x365, and not only for the sake of audit. Compliance is required for every human being, and not just for any particular country. For example, people often respond during audits that since their product is not for the US market/XYZ market, they are not complying with the guidance. However, patients across the globe have the right to be healthy and free of any health risks.

In my book, many such elements are presented, which you will not find in risk assessment and cGMP guidelines.

What would be your three top tips as pharma companies prepare and invest to create a compliance culture in a post-COVID world?
1. Act as if every day is an audit.
2. Work to win, and not for survival. You should target no observation or zero 483, and not just cross your fingers to pass the inspection.
3. Read my book, “Blue Ocean of Compliance.”