Batch or lot definition

Batch or lot means a single run of Product processed by a single execution of the instructions specified in the Batch Production and Control Record within the meaning of 21 CFR part 210.3(b)(2) and/or within the meaning of 21 CFR part 600.3(x), or its successor as in effect from time to time.
Batch or lot means a defined quantity of medical products processed in a single process or series of processes so that it is expected to be homogeneous.
Batch or lot means the hemp products produced during a period indicated by a specific code. (D) "Controlled substance" has the same meaning as found in section 3719.01 of the Revised Code.

Examples of Batch or lot in a sentence

  • A Batch or Lot Number (Application Identifier (10)) associates an item with information the responsible entity considers relevant for traceability of a trade item.

  • Batch (or Lot) (fibers) – n, For fibers, a quantity of material formed during one essentially continuous, uninterrupted production run under the same process conditions using one to three precursor lots.

  • Businesses can also combine different GS1 standards to streamline business processes such as traceability.The GS1 System is founded on a common set of globally recognised identification numbers called the GS1 Identification Keys, along with the ability to encode Attribute Data (e.g. Serial numbers, Best Before dates, Batch or Lot Numbers).Identification is the foundation of the GS1 System and is communicated via a barcode, an EPC/RFID tag, via e-Messaging and/or within a network.

  • Batch (or Lot): A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits.

  • The following batch definitions are recommended: Batch (or Lot) (general) – n, A quantity of material produced essentially at the same time and under the same conditions from a well-defined collection of raw materials.

  • Batch or Lot means a specific quantity of a test item or reference item produced during a defined cycle of manufacture in such a way that it could be expected to be of a uniform character and should be designated as such.

  • The representative of Afghanistan said that based on Article 20 of the Regulation on Export and Import of Medicines and Tools of February 2007, a sample ought to be taken from every Batch or Lot number of medicines and medical devices.

  • Technical evaluation criteria for offers of precursor services such as bulk load, testing, identity proofing, credential issuance, subscriber customer service account management, revocation, and credential validation as part of the basic service.

  • Batch (or Lot) (resin) – n, For a batch of resin, the definition varies depending on the specific mixing process: • In a batch mixing process a large vessel is charged with the desired types and quantities of raw ingredients.

  • Labelinga) Package labelsb) User Manualsc) IFUs (Instructions for Use)d) Product labels- Containing Content Identification, Revision, Part Numbers, Batch or Lot number or Serial Number Table 3 below illustrates the information that will be provided to the supplier by Siemens for each product type.


More Definitions of Batch or lot

Batch or lot means a quantity of:
Batch or lot. 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. Quality Control Master Document (QCMD)/Certificate of Analysis (COA): The Quality Control Master Document is equivalent to a Certificate of Analysis is the listing of all tests performed to release a batch and the results. Deviation: Event in the manufacturing process, testing and/or support system that is outside of approved operating parameters, the Product license, approved procedures, policies, standards, or specifications, or a departure from accepted cGMP’s.
Batch or lot means a specific quantity of a finished product 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.
Batch or lot means a defined quantity of starting material, packaging material, or finish product processed in a single process or series of processes so that it could be expected to be homogeneous in the case of continuous manufacture the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity, and to complete certain stages of manufacture it may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to from a final homogeneous batch;
Batch or lot means a defined quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. (Refer to ICH Topic Q 7 Good Manufacturing Practice for Active Pharmaceutical Ingredients)

Related to Batch or lot

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • Phase 1 means the first implementation phase of this section, beginning June 1, 2018 and ending May 31, 2022.

  • Batch means a specific quantity of Product 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.

  • Batch number means a unique numeric or alphanumeric identifier assigned prior to any testing to allow for inventory tracking and traceability.