USFDA expectations from Pharma

USFDA lists out expectations from Indian pharma

The message could not have been more clear: "Say what you do; Do what you say; Demonstrate that you actually did it (through proper documentation); Continuously seek improvements."

These were listed as the four crucial propositions that went into the making of the pillars of good quality systems, according to Leslie Ball, Assistant Commissioner and Deputy Director, Office of International Program at the US Food and Drug Administration (FDA). She was speaking in Hyderabad as part of the first in a series of workshops for the Indian drug industry and the regulators from India's Central Drug Standards Organisation (CDSCO).

The two-day meeting in Hyderabad, beginning on May 5, followed by workshops in Goa, Ahmedabad and Chandigarh, marks the beginning of a dialogue between the regulators and the Indian pharma industry. The workshops are being organized by the India office of the US Food and Drug Administration, along with the CDSCO in association with the Indian Pharmaceutical Alliance (IPA).

Ball said, "The workshop is an excellent opportunity for the FDA to explain its expectations" and also get the feedback from the industry.. Earlier, through a video link message, Howard Sklamberg, Deputy Commissioner, USFDA, Global Regulatory Operations and Policy, called for a quality culture in a company and said the "FDA has used a quality system approach to drug inspections since 2002."

He said, "the six elements the FDA inspected under these were: materials, equipment and facilities, production, laboratory, packaging and labeling." He also emphasized on the role of senior management in ensuring a quality culture within a company.

"In a healthy quality system, executive management not only allows but also rewards a staff who raises issues relating to operations and performance."

The meeting saw participation from the industry. Satish Reddy, vice chairman of Dr Reddy's Laboratories, who is also currently the president of the Indian Pharmaceutical Alliance, the association of Indian pharma companies, responding to what the workshop meant and what the industry expected from it, told Business Today, "this is a starting.... it is a great intervention on behalf of the FDA and the Indian regulator because it is important to have a dialogue and therefore it certainly is an effort in the right direction."-Source@BusinessToday

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