The much anticipated PDA Pharmaceutical Cold-Chain Management Conference concluded its first day of activities in Bethesda, Maryland today. Keen interest was paid by the 116 attendees on the FDA's first public acknowledgment of Technical Report No. 39, Cold-chain Guidance for Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products Through the Transportation Environment.
There were three regulating authorities among the presenters:
John Taylor, Quality Systems Manager of the MHRA (UK),
Vincent Tong, Compliance Officer, GMP Inspection Unit, Health Canada and
Nicholas Buhay, Acting Director, Division of Manufacturing and Product Quality, Center of Drug Evaluation and Research, FDA
In addition, there was one compendial affairs presenter, Claudia Okeke, PhD., Associate Director General Policies and Requirements Division, USP.
Each of these regulating authorities reiterated the need for good distribution practices, policies, procedures, training and adherence to their own governmental guidance and requirements documents. They are remarkably similar in content but enforcement varies as the meaning of the word "guidance" differs from country to country.
Mr. Taylor's presentation was, as always, button-down and to the point.
Mr. Tong's soft spoken and calculated presentation revealed no surprises as most are now familiar with HC's stringent regulation enacted last fall.
Ms. Okeke gleaned a pertinent few slides from her usual USP overview to deliver a well focused differentiation on the organization's mandatory requirements vs. guidance documents.
Mr. Buhay glided through FDA's expectations of compliance with a well prepared and sanitized presentation. However, he was remarkably non-committal and vague during the question and answer session as he carefully negotiated the regulatory waters with nearly incomprehensible double-speak. He did relinquish a glimpse into the mind-set of the agency when he stated that "in the future, the lack of temperature cycling studies will result in deficiencies".
On the bright side, he did state that when it came to the efforts of the PCCDG to promote and implement good distribution practices for the transportation of temperature sensitive products "the agency was quite satisfied with current level of activity" and alluded to areas of greater concern to the agency than what takes place in our little cold-chain corner of the world.
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At the conclusion of their presentations, the regulators were asked to comment on several questions from a captive and information-starved audience desperate for guidance. Most notable were two questions that PCCDG members have agonized over and discussed adnausium at every conference:
Q: does your agency allow shipping product outside of label claim provided there is sufficient stability data to support it?
Taylor: Yes, it is allowed by the MHRA provided it has been reviewed by the regulatory authority and an application for variance has been submitted.
Tong: Yes, it is allowable with supporting stability data and the consent of the fabricator (manufacturer).
Buhay: Yes, with supporting stability data.
Okeke: Yes, as long as cycling studies have been performed and support it.
Q: Is it necessary to monitor every shipment if validated packaging is used in a qualified distribution process?
Taylor: No. Periodic monitoring is acceptable
Buhay: No, as long as you can show control of your process and the occasion with a program that organizes your rationale.
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Overall, the panel were pleased with our efforts and encouraged us to proceed with developing additional industry guidance. The panel, at the invitation of committee chair Rafik Bishara, agreed to meet in the future with the PCCDG to address concerns they might have regarding future guidance. In all, it was a good day.
