Glossary Term
Batch Manufacturing
Definition
Batch Manufacturing is a production process in which products are created in specific, predetermined quantities (batches), with each batch moving through the manufacturing steps sequentially. In the MedTech industry, this approach is commonly used for producing medical devices, pharmaceuticals, and diagnostic tools, ensuring that each batch meets stringent quality and regulatory standards.
Relevance to the MedTech Industry
Batch Manufacturing ensures consistency, traceability, and compliance in the production of medical devices. By producing in controlled quantities, manufacturers can implement quality checks, validate processes, and adjust production methods as needed, ensuring that all products meet required specifications and regulatory standards.
Additional Information & Related Terms
Good Manufacturing Practices (GMP) Governs the quality standards for batch manufacturing in MedTech.
Process Validation Ensures that batch production consistently meets design and quality specifications.
Traceability Tracks materials and processes within a batch to ensure accountability and compliance.
Corrective and Preventive Actions (CAPA) Address issues identified during batch production or quality checks.