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    This document is a lot release request form submitted to the National Control Laboratory for Biologicals in Pakistan. It provides details of a shipment of Actemra 80mg that needs lot release certification, including: 1) Importer/manufacturer details, product details, solvent/diluent details, and details of the fee deposited. 2) It requests lot release for batch B2102B02 with a manufacturing date of 16/12/2019 and expiry of 15/06/2022. 3) The form is signed by an assistant manager from Roche Pakistan Limited, the importer of the product.

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    Ilovepdf Merged PDF

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    This document is a lot release request form submitted to the National Control Laboratory for Biologicals in Pakistan. It provides details of a shipment of Actemra 80mg that needs lot release certification, including: 1) Importer/manufacturer details, product details, solvent/diluent details, and details of the fee deposited. 2) It requests lot release for batch B2102B02 with a manufacturing date of 16/12/2019 and expiry of 15/06/2022. 3) The form is signed by an assistant manager from Roche Pakistan Limited, the importer of the product.

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    This document is a lot release request form submitted to the National Control Laboratory for Biologicals in Pakistan. It provides details of a shipment of Actemra 80mg that needs lot release certification, including: 1) Importer/manufacturer details, product details, solvent/diluent details, and details of the fee deposited. 2) It requests lot release for batch B2102B02 with a manufacturing date of 16/12/2019 and expiry of 15/06/2022. 3) The form is signed by an assistant manager from Roche Pakistan Limited, the importer of the product.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    67 views16 pages

    Ilovepdf Merged PDF

    Uploaded by

    Mufti Ali
    This document is a lot release request form submitted to the National Control Laboratory for Biologicals in Pakistan. It provides details of a shipment of Actemra 80mg that needs lot release certification, including: 1) Importer/manufacturer details, product details, solvent/diluent details, and details of the fee deposited. 2) It requests lot release for batch B2102B02 with a manufacturing date of 16/12/2019 and expiry of 15/06/2022. 3) The form is signed by an assistant manager from Roche Pakistan Limited, the importer of the product.

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    You are on page 1of 16

    (For Official se only)

    L.R No.
    Date of Receipt

    Lot Release Request Form


    The Director / Federal Government Analyst, Reference No. _________________
    National Control Laboratory for Biologicals, Dated: 19 May 2020
    Drug Regulatory Authority of Pakistan,
    Ministry of National Health Services, Regulations and Coordination,
    Prime Minister’s National Health Complex,
    Park Road, Chak Shahzad,
    Islamabad.

    Please issue the lot release certificate in respect of the biological product as detailed below.
    All the required documents are enclosed along with. The sample of the product will be provided if
    required:-

    Importer/ Manufacturer Details


    Name and address of the Importer/manufacturer Roche Pakistan Limited / Chughai Pharma
    Manufacturing Co Ltd, 16-3 Kiyohara-
    Kogyodanchi Utsunomiya Japan
    Commercial Invoice No. 1220323315
    Invoice Date 13/05/2020
    Date of Receipt of Shipment 21/05/2020
    Date of Endorsement of Invoice 18/05/2020
    Mode of Shipment By Air
    Port of Receipt of Shipment Karachi International Airport
    Name and Address of the Indent Holder (if
    applicable)
    Product details
    Name of Product Actemra 80mg
    Generic Name of Product Tocilizumab
    Registration No. 083134
    Lot No. B2102B02
    Manufacturing Date (dd/mm/yyyy) 16/12/2019
    Expiry Date (dd/mm/yyyy) 15/06/2022
    Storage Temp 2°C - 8°C
    Transportation Temp. 2°C - 8°C
    Name and address of Manufacturer Chughai Pharma Manufacturing Co Ltd, 16-3
    Kiyohara-Kogyodanchi Utsunomiya Japan
    Pharmaceutical form Liquid Form
    Type of Container Vial
    Number of Doses per container 1’s
    Volume per container 4ml
    Strength 80mg

    Controlled Document 001.1


    Solvent/ Diluent Details (in case of Freeze Dried Product)
    Solvent/ Diluent Name Withdraw the amount of ACTEMRA for intravenous
    infusion from the vial(s) and add slowly into the 0.9% or
    0.45% Sodium Chloride Injection, infusion bag or bottle.
    Lot No. -
    Type of container -
    Volume per container -
    Registration No. -
    Mfg. Date -
    Exp. Date -
    Name & address of Manufacturer -
    Details of Fee Deposited
    Bank Name Allied Bank Limited
    Bank Code
    Deposit Date
    Deposit Slip No.
    Amount Deposited 20,000/-
    Endorsement from DRAP □ Yes
    Lot Release Requested By Authorized Person
    Name Abdul Hannan
    Designation Assistant Manager Regulatory
    Signature
    Date 19/05/2020
    Telephone No. 021-34538890
    Cell No. 0321-2334030
    Name of Firm/ Pharmaceutical Company Roche Pakistan Limited
    Complete Address 1st Floor, 37-B, Block 6, P.E.C.H.S. Karachi
    Official Stamp

    For Official Use only:


    1. Summary Protocol Received □ Yes
    2. Lot release certificate from NRA of exporting country received □ Yes □ Exemption Certificate
    (in case of imported products)
    3. Batch Production Record received (for locally □ Yes □ No
    manufactured products).
    4. Copy of the Registration Letter received. □ Yes
    5. Copy of the endorsed paid bank challan received. □ Yes
    6. Copy of endorsed Invoice received. □ Yes
    Date of Receipt Received By (sig)
    Application accepted □ Yes Name
    If rejected (reason) Designation

    Assessment required □ Summary protocol review □ Laboratory Access


    Assigned reviewer
    Deadline for assessment

    Director/FGA

    Controlled Document 001.1

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