The US Food and Drug Administration's (FDA) Center For Drug Evaluation and Research has issued new guidelines for the packaging of test batches manufactured for Abbreviated New Drug Applications (ANDA), Abbreviated Antibiotic Applications (AADA) and Supplements.
The guidance, which aims to provide information concerning the processing, packaging and labeling of test batches, excludes test batches prepared for New Drug and for Investigational New Drug Applications reviewed by the Offices of Drug Evaluation (ODE) I or II.
According to the agency, the guidance covers test batch of finished drug products manufactured according to cGMP regulations and will deal with identification applied to a group of filled product containers, pharmabiz.com reported.
General guidelines, which focus on the entire test batch for all dosage forms also deal with the finished blend of active ingredient combined with most of the excipients along with processed material.
The applicant should always use production filling and packaging equipment for the test batch and also needs to fill multiple sizes of the proposed market containers from the same batch.
The batch record's packaging and labeling sections should comprise details such as drug product and label reconciliation and the record should include a packaging information summary table explaining the container or closure system.
Indication of the details pertaining to the total number of packaged containers, the distributed quantity and the destination of all disbursements of the packaged, is also mandatory.
Further, the guidelines concluded that the packaged product selected for testing should be representative of the batch.
