GMP Implementation Challenges Seen as More Asia-Pacific Regulators Join PIC/S
This article was originally published in PharmAsia News
As more Asia-Pacific health authorities join PIC/S to attract a wider manufacturing base and harmonize inspections, manufacturers have to grapple with GMP growing pains and overly strict GMP regulations in some countries.
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India’s new Department of Pharmaceuticals Secretary Aradhana Johri said India will challenge the “specious issue” of quality that she says is raised in other countries to simply exclude the Indian industry. Meanwhile, the department continues to resist the entreaties of India’s domestic pharmaceutical manufacturers to seek membership in PIC/S, which would require strengthening its inspectorate in ways that would pressure them to meet international standards.
To reduce the opportunity for data integrity failures in the microbiology lab, manufacturers should map out the workflow so that activities and expectations for employees are clearly spelled out. Having formalized processes will ensure that employees don’t cut corners.
The pharmaceutical industry should use alternative transportation routes and have a business continuity plan for dealing with distribution center closures in light of the COVID-19 pandemic. They should also work closely with third-party logistics providers in ensuring drivers are complying PPE requirements.