Dr. S. Eswara Reddy, Joint Drugs Controller (India), Central Drugs Standard Control Organisation (CDSCO)
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Central Drugs Standard Control Organization (CDSCO), in partnership with IDMA and the Drugs Control Administration of Dadra & Nagar Haveli and Daman & Diu, held a "One Day Workshop on Quality Culture" during which Dr. S. Eswara Reddy, Joint Drugs Controller (India), CDSCO, shared his views on the critical nature of developing a strong quality culture within the pharmaceutical industry. Following are the key insights from his address.
In the past few years, there has been an obvious change in how workshops and training sessions are conducted in the pharmaceutical industry. Typically, educational programs and regulatory actions have focused on large urban areas, failing to consider important manufacturing hubs in smaller towns and regions. This paradigm is, however, facing challenges that are leading to a more inclusive strategy that underlines the need to interact with manufacturing units regardless of their location.
The effort to hold workshops beyond large urban areas goes beyond mere logistics; it highlights a substantial cultural change within the sector. The regulatory framework is shifting, as authorities including the Government of India are taking a more proactive stance. Contrary to the past, when regulatory bodies primarily concentrated on enforcement, today’s regulators are taking steps to interact directly with manufacturers. This represents a transition from basic compliance to a cooperative relationship that emphasizes continuous education and improvement.
An important part of this cultural transition is the distinction between training and education. Training frequently emphasizes compliance, pushing individuals to follow protocols without really understanding the fundamental concepts. In contrast, education encourages a more profound insight, critical analysis, and proactive participation.
To clarify this difference, one might compare the approach to training a dog with that of educating a child. The goal of training a dog is to produce definite behaviors while avoiding any questioning of the reasons for those behaviors. On the other hand, educating a child includes supporting curiosity and helping them to grasp the reasons for particular necessary actions. In the pharmaceutical sector, just like in others, nurturing an educational setting can inspire individuals to grasp the 'why' of regulations and quality standards, resulting in more impactful compliance.
Training without this understanding may produce only a cursory adherence to the guidelines. As individuals understand the importance of their contributions, real engagement is required for the cultivation of a strong quality culture. An excellent case in point is waste management. Previously, waste disposal was often chaotic; however, with the rise in education about the topic, compliance with appropriate methods has greatly improved.
The pharmaceutical industry considers quality culture to be important. Within an organization, a culture focused on quality exists as a cooperative attitude that recognizes the importance of quality in every aspect. This is about acting morally, even without witnesses, and maintaining that public health and safety remain uncompromised. For the sake of preserving these quality standards across the industry, Good Manufacturing Practices (GMP) frameworks are currently operative.
Unlike most consumer goods, pharmaceutical products are unique as consumers cannot easily check their quality before buying. Consumers can assess features and specifications when they buy electronic goods. In contrast, the demand for pharmaceuticals is usually based on trust—trust in the manufacturer, the product, and the governing regulatory framework. This underscores the key importance of keeping a vigorous quality culture in the industry.
The pharmaceutical field is dealing with multiple challenges that impede its ability to maintain and cultivate a powerful quality culture. A lot of companies, particularly those that have multi-product facilities, have a tough time adhering to GMP regulations consistently. Smaller firms frequently do not have the resources or infrastructure needed for the development of strong formulations and data collection. Hence, ongoing education and training are important in resolving these gaps and securing that quality culture is deeply embedded at each organizational level.
Moreover, the critical nature of data integrity is beyond question. The ongoing industry shift to automated and technologically sophisticated processes makes it essential to preserve precise and reliable data for quality assurance and regulatory compliance.
The revised GMP schedule introduces one of the most important changes, which is the concept of the Pharmaceutical Quality System (PQS). The PQS puts full accountability for quality directly on manufacturers, thereby shifting the burden of quality standard enforcement away from previous systems in which regulatory agencies played a major role.
The PQS also confirms that senior management is responsible for the quality of the products their companies manufacture. This change indicates that quality assurance is no longer solely the duty of separate departments. What is needed is collaboration among all functions—maintenance, production, and quality control—to make sure there is constant adherence to superior quality standards.
A leadership-driven culture is very much shaped by quality. The modified GMP schedule stresses that for leadership to be committed to quality, the commitment needs to be both visible and tangible across the organization. To foster a company’s quality objectives, it is important to develop an environment for open dialogue, letting employees feel encouraged to ask questions, contest existing processes, and help in the company’s quality efforts.
In addition, teaching employees about why their actions are important enhances a greater sense of accountability. When staff members appreciate the value of their contributions to quality maintenance, they tend to take the responsibility seriously, even when there is no oversight. A move from training to education generates a more involved workforce that is better prepared to maintain quality standards.
Though the benefits of a quality culture are obvious, the implementation of this culture is often difficult. The drive to reduce costs, hasten time-to-market, and roll out new products tends to conflict with the effort to maintain superior quality standards. Also, the industry is experiencing a lack of skilled professionals, which may strain an organization’s ability to regularly implement quality practices.
Mergers and acquisitions further complicate the situation by possibly disturbing set quality practices and causing inconsistencies in organizational culture. To conquer these hurdles, organizations have to make sustainability over the long term a priority instead of short-term profits and should keep quality as the leading focus in their operational strategies.
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