|
ISPE Events
Guidance Documents
Training
Pharmaceutical Engineering Magazine
eLearning
Publications
Glossary
|
Young Professionals
Affiliates and Chapters
Advertise/Exhibit
Communities of Practice
Regulators
Volunteers
Students
International Leadership Forum
|
CPIP - Professional Certification
Employers
Job Seekers
|
ISPE Glossary of Pharmaceutical and Biotechnology Terminology
| Browse All Terms | |
| Beginning With | By Language |
| A B C D E F G H I J K L M N O P Q R S T U V W X Y Z :: All |
English Deutsch Francais |
Batch
A defined quantity of starting material, packaging material or product processed in one process or series of processes so that it could be expected to be homogeneous.
Publication Source: Rules and Guidance for Pharmaceutical Manufacturers and Distributors. Medicines Control Agency (MCA)
See also: Lot
Batch
(IEEE) Pertaining to a system or mode of operation in which inputs are collected and processed all at one time, rather than being processed as they arrive, and a job, once started, proceeds to completion without additional input or user interaction.
Publication Source: FDA Glossary of Computerized System and Software Development Technology
Batch
(ICH Q7) A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. In the case of continuous production, a batch may correspond to a defined fraction of the production lot. The batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval.
Publication Source: ISPE Baseline® Guide, Vol. 6: Biopharmaceutical Manufacturing Facilities
Publication Date: 2004
See also: Lot
Do you have a term that should be included in the glossary?
Submit a term for review
My ISPE
