BCG Vaccine:The laboratory has undertaken the testing of  BCG vaccine (live attenuated) final product. Quality control test performed on BCG vaccine are as per standard operating procedures ( SOPs) prepared in accordance with Indian Pharmacopoeia (2007)  and are as follows:

• Identity  

  • Colony Forming Unit  (CFU) test ;In vitro potency assay
  • Stability
  • Sterlity

Protocols & SOPs for testing of BCG vaccine on animals have been prepared for the following test parameters : 

Skin reactivity test

Test for Virulence

The number of containers required to be sent by the manufacturerare for testing are as follows;
                                                         

    
The quantity have been calculated on the basis of number of vials required for complete tests in a batch and to be retained , as well as pack size of the final container available in the market

• Scrutiny of Protocols
•    Information required to be submitted for evaluation of QC tests on final containers of BCG vaccine (lyophilized) is as follows:

Indigenous manufacturer:

Batch release certificate of manufacturer.
Certificate of analysis ( COA)of  Manufacturer.
Summary protocol for production and testing.
Manufacturing protocols (for new manufacturer).

Additional documents from indigenous manufacturer processing imported bulk

Import license number.
Bulk release certificate from national control authority of the Country of origin.
Certificate of analysis (COA) of bulk.
Manufacturing protocols.

Preparation of Reference Standard in Inter laboratory collaboration:
As per program of NIB, Preparation of  national reference standard of  biologicals is  to be taken up as per the need felt. The laboratory will initiate the preparation of the reference standard of BCG vaccine through inter laboratory comparisons to set up the criteria of stated property of the BCG vaccine with traceability to Primary standards

• Participation in any Inter  laboratory collaborative study:

NIB will organize  meetings with vaccine manufacturers to discuss need of the national/working reference standard for vaccines viz.,BCG Vaccine.All the concerned manufacturers will be invited in consultations with the IPC and DCGI for  working out the modalities.

Expansion of activities:

Institute w ill expand its activities by initiating standardization of  other tests such as test for moisture content, test for identification of BCG strains by PCR and viability of  BCG vaccine by using ATP assay as suggested in WHO TRS.

• Scientific Links:

Drugs controller general(India), FDA Bhavan,  New Delhi.
Secretary cum Scientific Director, Indian Pharmacopoeia Commission  Raj Nagar ,Ghaziabad.
National Institute for Biological Standards and Control,Potters Bar, United Kingdom.
United States Pharmacopoeia ( USP), Maryland, USA.
European Directrate for the Quality of Medicines& Healthcare (EDQM),Council of Europe, Strasbourg,France
Serum Institute of India, Pune, India.

BCG Vaccine Laboratory, Guindy,Chennai., India.

• Scientific Documents For References:

Indian Pharmacopoeia 2007.
Europian Pharmacopoeia 2008.
British Pharmacopoeia 2004.
WHO Technical Report Series, No. 745 (1987).
WHO Technical Report Series, No. 771 (1988). 
Biosafety in Microbiological and Biomedical Laboratory (CDC-NIH guidelines)  4th Edition (1999).

Conjugate Polysaccharide Vaccines

      This laboratory is being set up for taking up Quality Control testing of the
            following products :

            a)   Haemophilus influenza type b (Hib) conjugate vaccine
            b)   Meningococcal  conjugate vaccine
            c)   Meningococcal polysaccharide vaccine
           
      Efforts in progress to undertake the following activities  :

Hib conjugate vaccine  :

1. pH
2. Identity
3. PRP content
4. Adjuvant content
5. Residual moisture
6. Sterility
7. Pyrogen content
8. Preservative content
9. General safety test (Innocuity) abnormal toxicity
10. Free PRP
12. b) Preparation of Standard Operating Procedures (SOPs) for Quality  
       Control testing :    

• Draft SOPs prepared  are in the process of approval

• M/s Serum Institute of India,Pune
• M/s Shantha Biotech,Hyderabad
• M/s Panacea Biotech ,New Delhi
• M/s  Bharat Biotech,Hyderabad

The reference standard for   Hib conjugate vaccine is available with  The National Institute for      Biological Standards and Control ( NIBSC ), Potters Bar UK.

Meningococcal  group C conjugate vaccines

pH

Identity

Meningococcal polysaccharide content

Adjuvant  content

Preservative content

Residual moisture

Sterility

Pyrogen content

General safety test (innocuity ) abnormal toxicity

Inspection of final containers (visually )

 

Preparation of SOPs for Quality Control testing

• The Draft SOPs prepared  are in the process of approval

Meningococcal polysaccharide vaccines :

a)Tests recommended on finished productfor Meningococcal polysaccharide vaccines  by WHO TRS  594 and different pharmacopoeias ( IP 2007 and EP 2008)

Identity

Test of contamination for heterologous polysaccharide(applicable for monovalent   polysaccharide)

C oncenteration of polysaccharide

Sterility

Innocuity

Pyrogenicity

Toxicity

Estimation of molecular size

Residual moisture

 

Preparation of SOPs for Quality Control testing  :

•     The Draft SOPs prepared  are in the process of approval

• M/s Serum Institute of India,Pune
• M/s Biomed ,Ghaziabad

e) International reference standard source : The reference standard         for meningococcal group C conjugate vaccines and polysaccharide            vaccines is available with NIBSC, Potters Bar,UK

WHO Technical Report Series No.897,2000
WHO Technical Report Series No.924,2004
WHO Technical Report Series No. 594,1976
European Pharmacopoeia 2008
Indian Pharmacopoeia 2007