Inadequate investigations, insufficient laboratory systems, repeated errors due to improper implementation of corrective and preventive action (CAPA) are some of the current challenges confronting the Indian pharma industry, said AG Raghu, Technical Director, Gland Chemicals Pvt. Ltd.
The industry should make a concerted effort to move towards comprehending the quality parameters for the process and product development. It needs to assess the critical quality parameters and have a clear rational for every specification of the process in production. It should also ensure minimal justifications on scale-up process. In the absence of these practices, Indian pharma was issued a string of warning letters from global regulatory authorities. Now this has put the pharma industry into microscopic scrutiny mode by the regulators, especially in India, he added.
Going by the recurring inaccuracies at the pharma production plants, the regulators are doubtful on whether there are pharmaceutical quality systems in place, said Raghu while addressing on the topic ‘Quality systems-practical roadmap to sustainable quality culture’ at the Indian Pharmaceutical Association Platinum Jubilee Congress 2014.
Indian pharma needs to tread a quality path. It needs to sustain a quality culture, embark on intensive training and put in a robust system of excellence in place. At any point of time, the company should ensure it is totally cGMP compliant. Going by India’s performance in the exports front, it needs to device a global vision for pharmaceutical quality with principles of Quality Risk Management (QRM) embedded into every operation, he said.
Just as the pharma industry takes up formulation development or production of difficult to produce drugs, it needs to take up continuous product assessment, retention of documents and error reporting. It needs to develop products with highest quality attributes that are appropriate to meet the needs of patients, healthcare professionals and regulatory authorities, said Raghu.
The industry needs to establish and maintain effective monitoring and control systems for process performance and product quality. It needs to facilitate continual improvement where implementation of appropriate product quality systems are adopted. It is vital to enable and manage product and process knowledge from development through the commercial life of the product up to its discontinuation. “QRM is integral to an effective pharmaceutical quality system. Therefore, a proactive approach to identify evaluate and control potential risks to quality are required,” pointed out the Gland Chemicals technical director.
CAPA enhances process and product knowledge. It also supports continual improvement. There is also need for QRM to evaluate change. Regular reviews by the management would be vital for continual improvement of the Pharmaceutical Quality System. Regular monitoring of quality metrics leads to continuous improvement and this would help the industry move towards sustainable quality culture. It is also important for Indian pharma to adopt a Quality Culture Index which aims at being right the first time and plan to meet the unexpected. These factors will enable the industry to iron out the challenges of repeated errors that currently confront Indian pharma, Raghu said.