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NIB has established a state-of-art laboratory for quality testing of some of the important enzymes and hormones presenting indian market viz;
Streptokinase,Urokinase,Hyaluronidase,Thrombokinase,Human Chorionic Gonadotropin (hCG), Human growth hormone, Luteinizing hormone (LH) , Follicle stimulating hormone (FSH) derived from both natural and recombinant origin.
Quality control parameters for Streptokinase as per I.P. 2007 has been standardized.Certificate of Analysis (CoA) for the same has been submitted to the Office of the Drugs Controller India.Laboratory is ready to perform batch release of Streptokinase up to 60 batches per annum.
Standardization of Quality control parameters for Heparin injection and Human Chorionic Gonadotrophin as per I.P. 2007 is under progress.
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List of the Biologicals tested by the laboratory.
Streptokinase Injection I.P.2007
Details of the products used in standardization:
S. No. |
Name of the Product |
Batch No. |
Manufacturer |
Expiry Date |
1 |
Streptase |
29926011T |
M/s ZLB Behring |
03/2011 |
2 |
STPase |
8033 |
M/s Cadila Pharmaceuticals, Ahmedabad. |
05/2010 |
3 |
Thrombosolv |
795605 |
M/s VHB Life Sciences, Mumbai |
07/2010 |
Type of tests carried out and their compliance
S. No |
Name Product |
Name of Tests |
Pharmacopoeia complied |
1 |
Streptokinase Injection. I.P |
Clarity |
IP-2007 |
Particulate matter |
IP-2007 |
Determination of pH |
IP-2007 |
| Identification Method-A Clot Lysis |
IP 2007 |
| Streptodornase activity |
IP-2007 |
Streptolysin activity |
IP-2007 |
Potency by Chromogenic method |
IP-2007 |
Abnormal toxicity |
IP-2007 |
Sterility |
IP-2007 |
Bacterial endotoxin testing |
IP-2007 |
- Quantity of Samples required for testing of each batch of Streptokinase Injection for batch release certification.
Table-3
S.No. |
Name of Parameter |
Quantity Required for Q.C. Test |
Quantity of Repeat Samples |
Quantity of Retain
Samples |
|
|
Clarity, Particulate matter |
01 vial |
|
01 vial |
|
|
pH |
01 vial |
|
01 vial |
|
|
Identification Method-A Clot Lysis |
01 vial |
|
01 vial |
|
|
Identification Method-B Double Immuno Diffusion |
01 vial |
|
01 vial |
|
|
Streptodornase activity |
01 vial |
|
01 vial |
|
|
Streptolysin activity |
01 vial |
|
01 vial |
|
|
Potency by Chromogenic method |
01 vial |
01 vial |
01 vial |
|
|
Abnormal toxicity |
01 vial |
|
01 vial |
|
|
Sterility |
01 vial |
|
01 vial |
|
|
Bacterial endotoxin testing |
01 vial |
|
01 vial |
|
Total vials required |
10 vials |
01 vial |
10 vials |
|
Grand total |
- |
- |
21 vials |
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Scrutiny of Protocols- Information Required to be submitted by the manufacturer.
Laboratory requires the Technical dossier of the product and documents which have given in Table below
Documents required for release of test report of Streptokinase.
S.No. |
Documents Required |
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1. |
Letter from the Drugs Controller General (I) or the State Drugs Controller or the State Drugs Inspector requesting for QC testing of Streptokinase. |
- 2.
|
Import License Number (in case of an imported sample) or Manufacturing License Number (in case of an indigenous product). |
- 3.
|
Production Protocol & QC protocols (English version) for the relevant lot. |
- 4.
|
Batch Release Certificate from NCL of Country of Origin |
- 5.
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Certificate of Analysis of finished product with name of pharmacopoeia complied. |
- 6.
|
Name of three countries where the product is being used |
- 7.
|
Certification by the manufacturer for GMP compliance and compliance to specifications as per I.P.2007 |
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Expansion of Activities
Laboratory will take up the quality control testing of the following biologicals.
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a.Heparin Sodium Injection I.P.
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b.Heparin Calcium Injection I.P.
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c.Human Chrorionic gonadotrophin (hCG) hormone injection I.P.
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Enzymes and Harmone Lab |
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