Batch (or lot) definition

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;

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Batch (or lot) means a quantity of:

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;

Examples of Batch (or lot) in a sentence

• Invoices relating to Services for the production of a Batch will reference the Helix purchase order number, the corresponding CPL Estimate number, and the Batch or lot number and will be supported by a copy of, or reference to, the appropriate Production Record.

• Within ten (10) calendar days of ▇▇▇▇▇▇’▇ receipt of the Purchase Order, BAXTER shall provide a confirmation of receipt of each Purchase Order setting forth a Batch (or lot) number (if available), the delivery date that BAXTER will meet and setting forth ▇▇▇▇▇▇’▇ filling date for such order.

• Labelling or supplied documentation of products or materials delivered to CATALENT must include the following information: X ● Description, including strength ● Item code or part number ● Batch or lot number ● Storage conditions ● CUSTOMER name and address ● Date of manufacture, expiry/retest date ● Quantity and/or weight ● Average unit weight (where applicable) ● Container numbers ● Country of origin Containers must be tamper sealed in such a way that any tamper sealing is evident.

• During any calendar year or portion thereof in which Producer manufactures at least one Batch or lot, as applicable, of any Supplied Product, unless otherwise directed by Purchaser in writing, Producer shall perform commercial stability studies in accordance with the then current requirements of the International Committee on Harmonization with respect to such Supplied Product, at Purchaser’s cost.

• In case a Batch or lot of Substance or Finished Product fails to conform to the Specifications or applicable Regulatory Standards which has not been included in Finished Product shipped to Indevus but where it reasonably could be expected to possibly have a negative impact on Indevus’ supply of Finished Product, the matter will be discussed in the Supply Team.

More Definitions of Batch (or lot)

Batch (or lot) means the hemp products produced during a period indicated by a specific code. (E) "Controlled substance" has the same meaning as found in section 3719.01 of the Revised Code.

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). 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 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)

Batch (or lot) means 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. The batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval.

Batch (or lot) means a single run of Product produced 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.