Glossary
Batch Manufacturing
What is a Batch?
A batch is a specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.
What is Batch Manufacturing in Pharma?
Batch manufacturing in the pharmaceutical industry involves producing drugs in multiple steps, with production stopping at the end of each step before moving to the next. The materials move through the production line in batches, allowing for gaps between steps.
Importance of Batch Manufacturing in Pharma?
Batch manufacturing is the standard approach used for pharmaceutical production. It allows for the production of specific quantities of a drug that can be adjusted based on market demand. Batch manufacturing also enables the use of advanced equipment to enhance product quality.
What are the key processes of Batch Manufacturing in Pharma?
The key processes in pharmaceutical batch manufacturing include:
- Weighing and dispensing raw materials
- Mixing ingredients to form the drug substance
- Granulation or drying to achieve the desired particle size
- Compression into tablets or filling into capsules
- Packaging the finished drug product
