Pharma Voice

Conflict management in pharmaceutical industry

In the first of a three-part series, Dr B Philip Ashok, Vice President-Quality, Star Drugs and Research Labs, Tamil Nadu, India, and Dr SS Murugan, Scientific Director, RCC Laboratories India, Hyderabad, India analyse the major factors for conflict in pharmaceutical companies

The pharmaceutical industry is grappling with a conflict that has been persistent over decades and also showing signs of increasing in the current scenario of high level of regulations controlling the pharma industry. No prizes for guessing……the mentioned problem is the ever present and increasing conflict between Quality unit and Managements/Operations unit. Even though there are existing conflicts between other departments like the ones between operations and Marketing and so on, the conflicts between management/operations and the quality unit assumes greater importance, considering the fact that such unresolved conflict might impact the product quality.

Now, different companies have tried to adopt different strategies to overcome these problems since this problem cannot be ignored as this will ultimately affect the company's performance in terms of its quality systems and thereby the final product. This conflict has to be targeted with genuine commitment from the managements of pharma companies. This short series of articles will aim to cover the following topics.

• Reasons for the conflict
• Strategies to overcome this conflict (Conflict management)

Reasons for this conflict

The reasons for this rising conflict can be categorised as follows:

• Regulations in pharmaceutical industry
• Business strategies during projects, business development and other major initiatives
• Approach of the Business Management
• Approach of the QA professionals
• Attitude of operation staff towards quality

Regulations in the pharma industry

Dr B Philip Ashok, Vice President-Quality, Star Drugs and Research Labs, Tamil Nadu, India. He can be contacted at bphilip_ashok@hotmail.com

Regulations in pharma industry have always been in a dynamic state and every company involved in selling to different countries has to update itself to keep pace with it. The Quality Assurance (QA) team in a company has to cope with these changes by proper understanding of these up gradations or revisions, interpretation and getting necessary sanctions from the managements for implementation the same. If a company is working for many different types of markets, then the compliance to all their respective cGMP requirements have to be constantly monitored by the QA team. Hence, the pressures on a QA team have drastically increased as compared to the earlier period when companies were working for very limited markets around the world. And also about a decade ago, most countries, barring the US, EU and some South American and South African countries, were not inspecting the companies for GMP compliance.

The above situation has contributed substantially to increase the pressures of the QA team in most companies, especially the upcoming companies. The QA teams are not prepared to tackle this situation in the sense that they do not have fully trained staff who belong to the stable, loyal and committed category. Most companies in the medium segment are succumbing to the problem of higher rate of attrition as the talented employees keep moving every one-two years. Only a few companies like the MNCs or global Indian companies go through this situation with little fuss since their capacity to retain employees by constantly training employees help them do so.

Business strategies

Dr SS Murugan, Scientific Director, RCC Laboratories India, Hyderabad, India. He can be contacted at siva.murugan@rccltd.in

In the above scenario, most organisations would like to grab every possible business opportunity and there starts the conflict as the formulation development and the analytical development teams will launch into its respective development activity, technology transfers, validations and stability, but, the QA team, due to shorter timelines and higher grip of regulations and possible type of inspection/auditing enter into a conflict with the R&D, operations and the management.

Approach of the business management

Business heads have to always take the QA requirements into consideration while evolving business strategies, launching new projects and signing agreements and commitments. In our experience, this approach always stands appreciated by the customers from the regulated market. They only want the company to stick to the mutually agreed commitments and be transparent throughout the business relationship. The Business Managements have to be committed to the cause of the quality unit. This is undoubtedly one of the root causes, which can help avoid this conflict.

Approach of the QA professionals

We have tried our best to explain how regulations, current business strategies and timelines give rise to pressures inside technical teams, which turns into a conflict between Quality unit and the other departments. Now, the conflicts have to be dealt with seriousness to get the best result and finally the best quality product with the best data support.

Therefore a positive approach by QA professionals, play an important role to mitigate this problem and resolve issues amicably, while the projects are executed successfully. Even though it may be argued that the management commitment to quality of work and product is the key factor to overcome this problem, in our opinion the positive approach of the QA professionals can have a greater impact in solving this problem including bringing about management commitment to quality.

Attitude of operation staff towards quality

Due to the current trend in business strategies, the operational team is always under pressure to complete the targets. During the execution of the project or a specified activity, they tend to do haphazard planning, develop complacency such that they do not communicate the status of the project and decisions, try to take short cuts (or) avoid documentation in order to execute on time which in turn affects the quality. Here, there arises a conflict due to the following points:

The Operation team wants to fulfill the given targets, and quality criteria are forgotten while executing in such a hurry. At the same time, the Quality team develops an opinion that they are deliberately bypassing the quality requirements, and hence there develops a conflict. This will keep on widening unless the Business Management adopts an approach which is explained in detail below (or) the Operational teams start owning the responsibility for the overall quality standards of the project and the quality of the product.

The 'approach of business managements towards the QA' and the 'approach of the QA professionals towards the operations and management is considered to be a major factor for conflict. These two are dealt with in detail in the next part of this series which might help the management to resolve such conflicts.

To be continued…