The Center For Drug Evaluation and Research of the US Food and Drug Administration (FDA) has issued new guidelines for test batches packaging for abbreviated new drug applications (ANDA), abbreviated antibiotic applications (AADA) and supplements.
The guidance is aimed at providing information with regard to the processing, packaging and labelling of test batches.
According to the agency, the procedures apply to test batches manufactured for ANDAs, AADAs and supplements only, and exclude the batches prepared for new drug and investigational new drug applications reviewed by the Offices of Drug Evaluation (ODE) I or II.
The guidance covers test batch of finished drug products manufactured according to current good manufacturing practice regulations in support of ANDA or AADA.
Identification applied to a group of filled product containers that are set aside and held in unlabelled condition for future labelling operations will also be covered in the guidance.
Furthermore, the active ingredient blend combined with most of the excipients along with processed material, the unpackaged finished drug products, are also covered.
As part of the procedures, the applicant needs to use production filling and packaging equipment for the test batch, and will also have to fill multiple sizes of the proposed market containers from the same test batch.
The packaging and labelling sections of the batch record should contain details including drug product and label reconciliation, and a summary table of packaging information explaining the container or closure system.
Details pertaining to the total number of containers packaged, the quantity distributed and the destination of all disbursements of the packaged product should also be mentioned.
The guidelines have been considered as processes that are proposed to increase the quality adherence practices, which are critical for the pharma sector.