The bio-study samples needs to be representative of that particular batch. It can be sampled randomly by sponsor from all the packaged bottles and send it to testing laboratory.
For exhibit (submission) batches, minimum 100,000 units needs to be packed with the automatic packaging line that is going to be used for commercial marketing product. As you have to provide the executed batch records to the agency in the submission for review, there should be provision that the bio-study samples taken from the batch is packaged according to the regulatory requirement.
------------------------------
Gaurang Bhavsar, MS, RAC
Scientist-II, R&D and RA
Sunrise Pharmaceutical, Inc.
Rahway, NJ 07065
USA
------------------------------
Original Message:
Sent: 15-Jul-2017 09:11
From: Christopher Smith
Subject: Packaging tablets for a biostudy
Company making tablets for a biostudy for an ANDA. Plan for the market is to have the tablets made by a contract manufacturer and packaged into the final container closure (bottle) at a contract packager. Biostudy date is set but contract manufacturer is behind schedule such that the lot might not get shipped and packaged by the contract packager in order to meet the date of the biostudy. Not talking weeks here, maybe just a few days – all very "skin of teeth." Thought given to have contract packager send some of the container closures to the contract manufacturer who could then package some tablets immediately and ship to the biostudy site to meet timeline (like the day before the study is scheduled). They would still also send the lot to the contract packager for the planned packaging (and of course samples would go on stability). The product is very stable and the exact same container closure would be used. Difference is packing the biostudy tablets by hand rather than the commercial process. Of course it would all have to be justified with a complete risk assessment. I know it is a risk, but I think justifiable given the contract packager immediately packs the tablets into the exact same container-closure system and the bottles literally get sent to the biostudy site immediately such that there should be no question about stability. I think stability is the key issue and why we do three batches of the sizes required and package all three into the commercial container closure system and put on stability. Thoughts from others?
Christopher Smith, CQE, RAC
President, Coastal Pharmaceutical Consultants, Inc. ®
7950 Old River Road, Burgaw, NC 28425 USA
910-259-8877 (land)
910-789-1232 (mobile)
chrissmith@coastalpharmaconsultants.com