Scale Up and Exhibit Batches in Pharmaceutical Industry

Scaling up from the lab bench to commercial manufacturing is one of the most critical steps in pharmaceutical development. It is not just about making a bigger batch but it is about proving consistency, ensuring quality, and meeting regulatory expectations.

Below a simple checklist that often guides scale-up and exhibit batch execution:

Pre-Scale Up: finalize formulation, qualify raw materials, and confirm equipment readiness

Equipment & Facility: ensure calibration, cleaning verification, and cGMP compliance

Scale-Up Execution: monitor IPQC checks such as granule LOD, blend uniformity, hardness, and dissolution

Exhibit Batches: typically, a minimum of three commercial-scale batches with analytical testing and stability studies

Documentation: maintain accurate batch records, trending data, and handle deviations effectively

Regulatory & Tech Transfer: compile CTD Module 3 data, prepare for filing, and enable smooth technology transfer

Following a structured approach like this can make the difference between a smooth submission and unexpected hurdles later in the process.

The points are provided based on my experience in formulation R&D and technology transfer.

From your experience — what is the toughest part of scale-up or exhibit batches: process reproducibility, analytical alignment, or documentation? Provide your experiences and suggestions.

Read also: Scale-up Process in Pharmaceutical Industry

Resource Person: Vijay Agrawal