SOP tetanus

Document Sample
SOP tetanus Powered By Docstoc
					                            GOVERNMENT OF PAKISTAN
                               MINISTRY OF HEALTH
                        National Control Laboratory (Biologicals)
 Title               Procedure for Lot Release of Biological Products
SOP No.                              036/A-NCL-LR




                                  SOP
      (STANDARD OPERATING PROCEDURE)



 SOP No.                036/A-NCL-LR
 Title:                 Procedure for Lot Release of Biological Products.
 Effective Date:        01-09-2006
 Revision No.           00.00.00
 References:             Training manual: licensing, lot release, laboratory
                            access WHO/V&B/01.16: April 2001.
                         Drugs Act 1976: The Drugs (Licensing,
                            Registering & Advertising) Rules 1976.
 Written by:            Ajmal Sohail
                        Assistant Drugs Controller,
                        Ministry of Health, Islamabad.
 Reviewed by:           Mrs. Anwar Begum
                        Director,
                        National Control Laboratory (Bio), Islamabad.
 Approved by:           Dr. Farnaz Malik
                        Drugs Controller,
                        Ministry of Health, Islamabad.
 Authorized by:         Maj. General (r) Shahida Malik H.I.(M).
                        Director General,
                        Ministry of Health, Islamabad.




Written by         Reviewed by        Approved by         Authorized by     Page
                                                                            1 of 9
                                   GOVERNMENT OF PAKISTAN
                                      MINISTRY OF HEALTH
                               National Control Laboratory (Biologicals)
    Title                 Procedure for Lot Release of Biological Products
   SOP No.                                036/A-NCL-LR



1. Purpose:
   1.1.   The purpose of this SOP is to describe the method to obtain lot release
          certificate from National Control Laboratory (Bio) for release of the vaccines,
          sera and interferon into the market.
   1.2.   Lot release of biological products is performed within the framework of section
          14 of the Drugs Act 1976 (XXXI of 1976) by National Control Laboratory
          (Bio).


2. Scope:
   2.1.   Verification that the vaccines, sera and interferon, whether imported or locally
          manufactured are in conformity with the approved specifications i.e. they
          conform the Drugs (Specifications) Rules, 1978.
   2.2.   This applies to all the vaccines, sera and interferon, as defined under rule 2 (bd)
          of The Drugs (Licensing, Registering & Advertising) Rules 1976, whether
          imported or locally manufactured.


3. Responsibilities:
   3.1.   It is the responsibility of the Importers and/or manufacturers to follow this
          procedure.
   3.2.   Authorized officer (Officer notified by the Federal Government for the release
          of imported biological products) is responsible for ensuring that this procedure
          is being followed.
   3.3.   Federal Government Analyst, National Control Laboratory (Bio), is responsible
          to issue lot release certificate on the prescribed form (Annex-3).


4. Requirements:
   4.1.   Samples of each lot in quantity as specified by National Control Laboratory
          (Bio). The quantity may be revised from time to time as the National Control
          Laboratory (Bio) deems necessary. (Annex-1).
    Written by          Reviewed by           Approved by         Authorized by       Page
                                                                                      2 of 9
                                  GOVERNMENT OF PAKISTAN
                                     MINISTRY OF HEALTH
                              National Control Laboratory (Biologicals)
    Title                 Procedure for Lot Release of Biological Products
   SOP No.                                036/A-NCL-LR

   4.2.   Summary protocol of each lot. (Summary Protocol: A document summarizing
          all manufacturing steps and tests performed along with results for that
          particular lot of vaccines, sera and interferon, which is certified and signed by
          the authorized person of the manufacturing company)
   4.3.   Lot release certificate from NRA (National Regulatory Authority) of exporting
          country (for imported products).
   4.4.   Batch Production Record (BPR) of the particular lot (for locally manufactured
          products).
   4.5.   Lot release fee for each lot as specified by the National Control Laboratory
          (Bio). The Lot release fee may be revised from time to time as the National
          Control Laboratory (Bio) deems necessary. (Annex-4).
   4.6.   Copy of the paid challan.


5. Procedure:
   5.1.   Imported Vaccines, Sera and Interferon:
          5.1.1.   Upon arrival of the shipment/consignment the importer applies for the
                   grant of provisional release of the consignment. The authorized officer
                   (Officer notified by the Federal Government for the release of
                   imported biological products) grants provisional release of the
                   consignment, to take from port to importer’s warehouse for proper
                   storage, within a time period not exceeding two working days, with the
                   direction to obtain lot release certificate from National Control
                   Laboratory (Bio) before release of the drug into the market.
          5.1.2.   Upon receiving the consignment the importer sends the sample of each
                   lot/batch, within a week, directly to National Control Laboratory (Bio)
                   to obtain lot release certificate, on prescribed form (Annex-2) in
                   quantity specified by National Control Laboratory (Bio) along with the
                   documents and lot release fee as described in section 4.
          5.1.3.   Upon receiving the request for issuance of lot release certificate, the
                   National Control Laboratory (Bio) will issue a certificate on prescribed
   Written by           Reviewed by          Approved by         Authorized by      Page
                                                                                    3 of 9
                                GOVERNMENT OF PAKISTAN
                                   MINISTRY OF HEALTH
                            National Control Laboratory (Biologicals)
 Title                   Procedure for Lot Release of Biological Products
SOP No.                                  036/A-NCL-LR

                form (Annex-3), within a time frame ranging from two weeks to eight
                weeks depending upon the assessment required, as per WHO
                recommendations.
       5.1.4.   Upon receiving the lot release certificate from National Control
                Laboratory (Bio) the importer submits it to the authorized officer
                (Officer notified by the Federal Government for the release of
                imported biological products) to get permission for the sale of the
                products accordingly.
       5.1.5.   The authorized officer (Officer notified by the Federal Government for
                the release of imported biological products) will grant permission to
                the importer, within two working days of receipt of lot release
                certificate, to place the product on the market.


5.2.   Locally Manufactured Vaccines, Sera and Interferon:
       5.2.1.   Upon completion of manufacturing process and laboratory testing of
                each lot the manufacturer sends the sample of each lot/batch, within a
                week, directly to National Control Laboratory (Bio) to obtain lot
                release certificate, on prescribed form (Annex-2) in quantity specified
                by National Control Laboratory (Bio) along with the documents and lot
                release fee as described in section 4.
       5.2.2.   Upon receiving the request for issuance of lot release certificate, the
                National Control Laboratory (Bio) will issue a certificate on prescribed
                form (Annex-3) within a time frame ranging from two weeks to eight
                weeks depending upon the assessment required, as per WHO
                recommendations.


5.3.   Sampling:
       5.3.1.   Representative samples of each lot are collected by importer and/or
                manufacturer, in quantity specified by National Control Laboratory
                (Bio).
Written by           Reviewed by           Approved by             Authorized by   Page
                                                                                   4 of 9
                                  GOVERNMENT OF PAKISTAN
                                     MINISTRY OF HEALTH
                              National Control Laboratory (Biologicals)
    Title                  Procedure for Lot Release of Biological Products
   SOP No.                                 036/A-NCL-LR

          5.3.2.   Sample containers are properly sealed and marked by name, signature
                   and stamp of the authorized person (the person authorized by the
                   importer/manufacturer for the said purpose) with date of sampling.
          5.3.3.   Sealed samples are sent to the Director, National Control Laboratory
                   (Bio), on prescribed form along with the requirements as described in
                   section 4 at the postal address given below:
                   The director,
                   National Control Laboratory (Biologicals),
                   At National Institute of Health,
                   Chak Shehzad, Islamabad.
          5.3.4.   The samples should be sent in accordance with the temperature
                   requirements of the biological products.


6. Appeals Against Decision of National Control Laboratory (Bio):
   6.1.   In case of the rejection of the request for release of a lot the aggrieved party
          may file an appeal against the decision of the National Control Laboratory
          (Bio) as per procedure described under section 22 of the Drugs Act 1976.


7. Reference Documents:
   7.1.   Annex-1: Quantity of samples.
   7.2.   Annex-2: Lot release request form.
   7.3.   Annex-3: Lot release certificate.
   7.4.   Annex-4: Schedule of testing Fees.


8. Change Control History:




    Written by          Reviewed by           Approved by         Authorized by    Page
                                                                                   5 of 9
                                          GOVERNMENT OF PAKISTAN
                                             MINISTRY OF HEALTH
                                      National Control Laboratory (Biologicals)
           Title                  Procedure for Lot Release of Biological Products
          SOP No.                                 036/A-NCL-LR

                                                 Annex-1


Quantity of vaccines, sera & interferon required for the issuance of lot release certificate.

                                                      Quantity (vials/unit packs)
              Product
                                                Imported*               Locally Manufactured
   Tetanus Toxoid.
            0.5 ml                                  25                                 80
        5.0 ml                                      05                                 30
   Anti Tetanus Sera.
            1.0 ml                                  10                                 40
            3.0 ml                                  05                                 30
            5.0 ml                                  05                                 30
   Oral Polio Vaccine.
            5.0 ml                                  05                                 40
   Measles Vaccine.
            5.0 ml                                  05                                 40
   Rabies Vaccines.
            0.5 ml                                  20                                 80
   Hepatitis-B Vaccine.
            0.5 ml                                  15                                 40
            1.0 ml                                  10                                 30
            5.0 ml                                  05                                 30
   Snake Venom Anti Sera.
            5.0 ml                                  05                                 40
            10.0 ml                                 05                                 30
   Interferon                                        05                                 40

               Note: The lot release certificate for vaccines & sera other than mentioned in above list
      will be issued on the basis of summary protocol review only, due to non availability of testing
      facility at present. Therefore the request for the release of such products is required to be
      accompanied by summary protocol, lot release certificate from NRA (National Regulatory
      Authority) of exporting country and samples in quantity 02 vials/unit packs for physical
      examination and verification of labeling requirements as per Drugs Act 1976 and Rules framed
      there under.

      * The quantity of samples for imported products is based on minimum requirement to carry out
      the most essential tests and applies only to those products which are accompanied by lot release
      certificate from NRA (National Regulatory Authority) of exporting country. The request for the
      release of imported products, accompanied by exemption certificate from NRA (National
      Regulatory Authority) of exporting country, will be subjected to full range of testing and
      requirements (lot release fee and quantity of samples) applicable to locally manufactured
      vaccines, sera and interferon.


           Written by           Reviewed by           Approved by          Authorized by        Page
                                                                                                6 of 9
                                    GOVERNMENT OF PAKISTAN
                                       MINISTRY OF HEALTH
                                National Control Laboratory (Biologicals)
     Title                  Procedure for Lot Release of Biological Products
    SOP No.                                 036/A-NCL-LR

                                             Annex-2

                                     Lot Release Request Form
The Director,                                                    No.
National Control Laboratory (Bio),                               Dated:
Ministry of Health,
Islamabad.

        Please find enclosed herewith sample of biological product as detailed below along with
the required documents, for the grant of lot release certificate.

Product name _______________________________________________________________
Manufacturer ________________________________________________________________
Date of receipt of shipment (in case of imported products) ____________________________
Lot No. ____________________________             Lot size/quantity. _____________________
Mfg. date __________________________             Expiry date __________________________
Pharmaceutical form _________________            Doses/Vial __________________________
Diluent ____________________________             Diluent lot No. _______________________
Storage conditions ___________________           Quantity of sample ____________________
Sample conditions ____________________________________________________________

Requested By:
Name _____________________________      Title _______________________________
Signature __________________________    Date _______________________________
Address ____________________________________________________________________
        ____________________________________________________________________

For official use only:

Date of receipt _____________________ Quantity of samples __________________________
Sample conditions _______________________________________________________________

Summary protocol received               □ Yes        □ No
Lot release certificate from NRA of exporting country received (in case of imported products).
                                        □ Yes        □ No
Batch Production Record received (for locally manufactured products).
                                        □ Yes        □ No
Copy of the paid bank challan received. □ Yes        □ No

                                                   Received by: __________________________

Assessment required:        Summary protocol review / Laboratory access
Assigned reviewer: ______________________________________________________________
Deadline for assessment: _________________________________________________________

                                                                       _____________________
                                                                               Director


     Written by           Reviewed by           Approved by           Authorized by       Page
                                                                                          7 of 9
                                     GOVERNMENT OF PAKISTAN
                                        MINISTRY OF HEALTH
                                 National Control Laboratory (Biologicals)
        Title                 Procedure for Lot Release of Biological Products
       SOP No.                                036/A-NCL-LR

                                            Annex-3


                    LOT RELEASE CERTIFICATE
Ref. No.                                                                         Dated:

The following Lot of ___________________________________________________
produced by __________________________________ in ______________________
whose lot number appears on the label of the final container, received from
___________________________________ bearing No. _______________________
dated _______________meets / does not meet:

i.        All national requirements.
ii.       WHO Requirements for Biologicals _________________________________
          Requirements for _________________________________________vaccine).
iii.      WHO General Requirements for Manufacturing Establishments and Control
          Laboratories.

                    Lot No.                Manufacturing Date                  Expiry Date



It is certified* that:

      THE ABOVE LOT OF THIS BIOLOGICAL PRODUCT IS APPROVED/
       REJECTED FOR RELEASE.




                                                    __________________________________
                                                    Director / Federal Government Analyst




*As a minimum this certificate is based on scrutiny of the manufacturing and testing protocols.




       Written by         Reviewed by           Approved by           Authorized by        Page
                                                                                           8 of 9
                                   GOVERNMENT OF PAKISTAN
                                      MINISTRY OF HEALTH
                               National Control Laboratory (Biologicals)
    Title                  Procedure for Lot Release of Biological Products
   SOP No.                                 036/A-NCL-LR

                                          Annex-4

Schedule of Lot Release Fees
Imported Vaccines, Sera and Interferon:
       The lot release fee for all the imported vaccines, sera and interferon is Rs.
5,000.00 per sample.

Locally Manufactured Vaccines, Sera and Interferon:
       The lot release fee for locally manufactured products is given below:

                          Product             Fee per Sample (in rupees)
                 Tetanus Toxoid.                         10,000.00
                 Anti Tetanus Sera.                      10,000.00
                 Oral Polio Vaccine.                      6,000.00
                 Measles Vaccine.                         6,000.00
                 Rabies Vaccines.                        10,000.00
                 Hepatitis-B Vaccine.                    15,000.00
                 Snake Venom Anti Sera.                  10,000.00
                 Interferon                               6,000.00


Note:
       The lot release fee should be submitted at any branch of National Bank of
Pakistan in the favour of head of account as given below:
               C-Non Tax Revenue.
               C02- Receipts from Civil Administration and other Functions.
               C028- Social services.
               C02871- Health other Receipts.




    Written by          Reviewed by           Approved by          Authorized by       Page
                                                                                       9 of 9

				
DOCUMENT INFO
Shared By:
Categories:
Tags: tetanus
Stats:
views:76
posted:7/30/2010
language:English
pages:9
Description: SOP tetanus