The US FDA’s Center For Drug Evaluation and Research has now issued the guidelines for the packaging of test batches for Abbreviated New Drug Applications (ANDA), Abbreviated Antibiotic Applications (AADA) and Supplements.
The key objective of the guidance is to provide information concerning the processing, packaging and labelling of test batches.
ANDAs and AADAs are usually approved based on data from a single test batch. It is critical that all testing be conducted on samples that represent the entire batch and mimic the product which will be marketed post-approval. Therefore, the November 8, 1991 and August 4, 1993 instructions from the Office of Generic Drugs was for solid oral dosage forms’ entire test batch. Since then the industry has periodically requested for additional clarification on the packaging of the test batch for all dosage forms, said the drug regulatory authority.
Now the procedures issued apply only to test batches manufactured for ANDAs, AADAs and supplements. Test batches prepared for New Drug and for Investigational New Drug Applications which are reviewed by the Offices of Drug Evaluation (ODE) I or II, are not covered under this guidance.
The guidance covers test batch of finished drug products manufactured according to cGMP regulations in support of an ANDA or AADA. It is also for bio-equivalence studies, products having the same physical and chemical properties, within specified limits, throughout the batch. In addition, representative or random sampling should be intended to assure that the sample accurately portrays the material being sampled. It will also deal with identification applied to a group of filled product containers that are set aside and held in unlabelled condition for future labelling operations. The finished blend of active ingredient combined with most, if not all, of the excipients along with processed material which are unpackaged finished drug products are also covered.
General guidelines of the policy focus on the entire test batch for all dosage forms which should be completely processed and packaged. The applicant should always use production filling and packaging equipment for the test batch. It also mandates that the applicant should fill multiple sizes of the proposed market containers from the same test batch. An attempt should be made to fill the same number of containers for each container size. For instance a storage drum is not considered a market container. A bulk container intended for sale to repackagers is considered a market container.
The packaging and labelling sections of the batch record should contain details, including drug product and label reconciliation. The batch record should include a summary table of packaging information describing the container or closure system. Details of the total number of containers packaged and the quantity disbursed and the destination of all disbursements of the packaged product should also be indicated.
Further the packaged product selected for testing should be representative of the batch. The test batches should be labelled in accordance with the current requirements of Title 21 CFR and the United States Pharmacopoeia, said the guideline.
The Indian industry has viewed these guidelines as processes intended to increase the quality adherence practises which are indispensable for the pharma sector.