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

Batch

A Batch sometimes called Lot is defined as an entity, by either time or quantity or both, of a product that is intended to have a uniform character and quality. A batch must be produced within predefined and specified conditions following a defined manufacturing cycle or process.

or

A specific quantity of an intermediate or API intended to have uniform character and quality, within specified limits, and produced according to a single manufacturing order during the same cycle of manufacture. A batch may also mean a specific quantity of material or API processed in one process or series of processes so that it could be expected to be homogenous

Batch Abstract

A Batch Abstract is the summary of all documents which are associated with the Manufacture, Packaging and Quality Control of a batch of Drug Substance / API or a Drug Product.

Batch Deviation

A batch deviation is an occurrence followed by a change to the predefined process or condition detailed in the Batch Manufacturing Record (BMR).

Batch Manufacturing Record

The Batch Manufacturing Record (BMR) is the necessary quality and GMP documentation for tracing the complete cycle of manufacture of a batch or lot.

Batch Number

The batch number is a combination of numbers and/or letters which should uniquely identify a batch or lot. This numbering system must assure that the complete history for the manufacture and distribution is traceable.

Batch Packaging Record

A Batch Packaging Record is a document referencing the bulk Product and Packaging Materials used for the process including but not limited the details of In- Process controls.

Batch Record Review

The process of reviewing and approving all Pharmaceutical Product Manufacturing and control records is called the Batch Record Review. This includes but is not limited to Packaging and Labelling. The Batch Record review is performed by the Quality Unit to determine compliance with all established approved written procedures before a Batch is released.

Batch Release

The batch release ids the process performed by the Quality unit of releasing a Batch or lot of Drug Substance / Active Pharmaceutical Ingredient (API) or Drug Product based on a Batch Record Review to the market (distribution). 

Best Practice

Best Practice systems, procedures and processes that would be considered to meet an optimal level of compliance are often called Best Practice to highlight that these do not only comply with the GMP rules but also are optimal in regard to a robust or lean system or process.

Bio-Burden

Bio-Burden is the amount of viable microorganisms on or in a Manufacturing area, Raw Material, Packaging Component, Bulk Product, Intermediate, Semi-Finished or Finished Product.

Biologic active pharmaceutical ingredient

A material originating from a biological manufacturing process intended to furnish pharmacological activity or other direct effect in the cure, treatment, or prevention of disease or conditions of human beings.

Biologic product

Any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment, or cure of diseases or conditions of human beings.

Biologics License Application

The Biologics License Application is the equivalent of an NDA for biopharmaceutical and biotechnology products.

Brand name drug

A drug that is sold under the unique, trademarked name selected by the manufacturer rather than under its chemical name

Bulk Product

Bulk Product is the Product, which has completed all Manufacturing steps. The Bulk product did not undergo the packaging process yet