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  • Aurex Laboratories LLC: RLD Procurement Checklist

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    Pranav Patel
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    This document from Aurex Laboratories LLC is a procurement checklist for reference listed drugs (RLDs) that includes 14 items. It requests information on the brand name, strength, name, number of lots and samples required of the RLD for formulation development, dissolution profiles, analytical development, stability studies, pilot bio studies, and stability studies along with process validation batches stored under three conditions. Spaces are provided to document the requested and approved details.

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    RLD procurement requirement check list

    Original Title

    RLD Procurement Requirements

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    This document from Aurex Laboratories LLC is a procurement checklist for reference listed drugs (RLDs) that includes 14 items. It requests information on the brand name, strength, name, number of lots and samples required of the RLD for formulation development, dissolution profiles, analytical development, stability studies, pilot bio studies, and stability studies along with process validation batches stored under three conditions. Spaces are provided to document the requested and approved details.

    Copyright:

    © All Rights Reserved
    Download as XLSX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as xlsx, pdf, or txt
    46 views2 pages

    Aurex Laboratories LLC: RLD Procurement Checklist

    Uploaded by

    Pranav Patel
    This document from Aurex Laboratories LLC is a procurement checklist for reference listed drugs (RLDs) that includes 14 items. It requests information on the brand name, strength, name, number of lots and samples required of the RLD for formulation development, dissolution profiles, analytical development, stability studies, pilot bio studies, and stability studies along with process validation batches stored under three conditions. Spaces are provided to document the requested and approved details.

    Copyright:

    © All Rights Reserved
    Download as XLSX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as xlsx, pdf, or txt
    of 2

    Aurex Laboratories LLC

    RLD Procurement Checklist


    S.No

    RLD Pre requisites

    Brand Name

    Strength of the Product

    Name of the product

    Number of different lots required

    Number of samples required for other strengths

    Pack size/type required

    Minimum expiration required

    Samples required for formulation development

    Samples required for Dissolution profiles

    10

    Samples required for Analytical development

    11

    Samples required for R&D stability studies

    12

    Samples required for pilot bio studies

    13

    Samples required for stability studies along with PV


    batches (On three conditions)

    14

    Samples required for stability studies along with PV


    batches (On three conditions)

    15

    Others

    Requested By:
    Date:

    es LLC

    ent Checklist
    Requirements

    Approved By:
    Date:

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