Indian pharma needs synergistic work culture to propel stronger quality standards: AG Raghu


Indian pharmaceutical industry needs a synergistic work culture to spur strong quality standards. It is here the implementation of robust quality system will trigger knowledge management and facilitate continual improvement, stated AG Raghu, pharma consultant, Santhana Gopala Consultants. With the Union government actively considering to become a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), indicates that the good manufacturing practice (GMP) standards will move from Schedule M to PIC/S GMP, he added. 

Becoming member of PIC/S will make Indian regulatory system robust and on par with international standards. The PIC/ S GMP standards are equivalent to EU – GMP for pharmaceutical products and ICH Q7 – GMPs for Active Pharmaceutical Ingredients. So Indian pharma should be future ready to adopt one global standard, stated Raghu at the recently concluded KDPMA programme titled ‘The Essential Journey From Schedule M to PIC/S’.

The pharma consultant who was deliberating on the topic ‘ Moving to PIC/S: A need for culture change’ noted that industry should be ready for one global standard. It would not only create robust pharmaceutical quality system but sustain the same. “Quality culture in a person begins with a passion for excellence. It is working beyond just compliance. It indicates that quality is not hindrance for success, but as necessity for a company to make decisions that benefits patients. A healthy quality culture requires management ownership and accountability. For this, the organization structure needs to foster cross functional ownership of quality that motivates employees to be zealous about quality,” he stated.

Moving towards PIC/S needs a culture change. To achieve this objective, we should focus on Pharmaceutical Quality System. This is mentioned in Chapter1 of PIC/S GMP guide part I and section 2 of part II. Production systems should have regular internal audits and management reviews. This is described in detail in ICH Q10, he said. Stating that quality culture is doing right things when nobody is watching, Raghu expressed that it could be established with a six-pronged excellence framework. These are building capability, corporate culture, business continuity planning, robust quality systems, quality metrics and communication.

In order to build capability for a positive corporate culture, there is need for valuable leadership, adequate human resources to delegate tasks and ensure effective skill development to fulfill the roles. Driven by leadership, corporate culture plays a key role in the creation of a sustainable quality culture. Senior management needs to engage employees, take shop floor rounds, understand the real issues and seek inputs from operators. Such a proactive approach can enable resolve issues and ensure continual improvement, stated Raghu.

Communication too with employees, customers, vendors and regulatory authorities will create transparency in the organisation. Indian pharmaceutical industry has created world class facilities. It should focus on creation of world class leaders. For this needs to be associated with the academia to generate the job-ready qualified-quality professionals. This will enable us develop a culture to propel stronger quality standards, said Raghu.

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