Blood Product Lab

The Blood product laboratory was set up with the aim assuring the quality  of plasma derived products marketed in india. Plasma derived medicinal products are biologics extracted and purified from human plasma.Since these biological therapeutics are inherently complex and variable, a vigilant monitoring is required to ensure the quality as well as safety of such products.

The biologicals tested are

1. Human albumin (25%)
2. Human albumin ( 5%)
3. Human plasma protein fraction (5%)

 

Type of tests carried out and their compliance

S. No	Name Product	Name of Tests	Pharmacopoeia
1	Human Serum Albumin 5% Human Serum Albumin 20% Human Serum Albumin 25%	Identification A-Precipitation	IP 2007
		PH (2.4.24)	IP-2007
		Haem Content	IP-2007
		Molecular Size Distribution	EP-2008 BP-2009
		Total protein	IP-2007
		Stability	IP-2007
		Sodium	IP-2007
		Potassium	IP-2007
		Anti-HIV	IP-2007
		Anti-HCV	IP-2007
		HBsAg	IP-2007
		Sterility	IP-2007
		Pyrogens	IP-2007
		Abnormal toxicity	IP-2007
2	Human Plasma Protein Fraction	Identification A-Precipitation	IP-2007
		Haem Content	IP-2007
		Molecular Size Distribution	EP-2008 BP-2009
		Total protein	IP-2007
		Stability	IP-2007
		Sodium	IP-2007
		Potassium	IP-2007
		Anti-HIV	IP-2007
		Anti-HCV	IP-2007
		HBsAg	IP-2007
		Sterility	IP-2007
		Pyrogens	IP-2007
		Abnormal toxicity	IP-2007

 

1. Quantity of Samples required for testing of each batches of Blood Products for batch Release Certification. (Human albumin and Human plasma Protein Fraction)

 

S. No.	Name of Product	Quantity Required for Q.C. Test	Quantity of Retain Samples
1	Identification, PH, Haem Content, Molecular Size Distribution, Total protein, Sodium, Potassium	Two Bottles	Six Bottles
2	Stability	One Bottles
3	Sterility	One Bottles
4	Pyrogens	One Bottles
5	Abnormal toxicity	One Bottles
	Total  (6+6=12)	Six Bottles	Six Bottles

 

Scrutiny of Protocols

Information Required to be submitted by the manufacturer.Laboratory requires the Technical dossier of the product and documents, which have given below.

Documents required for release of test report of Blood Products

S. No.	Documents Required	Description of Products
1	Certificate of Analysis of the finished product with name of Pharmacopoeia complied	All Products
2	Plasma pool certificate from National Control Laboratory (NCL)/ Manufacturer	All Products
3	Batch Release Certificate from NCL of Country of Origin	Product that have already undergone official Batch release procedure by the National Regulatory Authority (NRA) OR NCL from Country of Origin. (Category-I)
4	Letter from NRA regarding exemption from lot to lot release	The Products that have been exempted from lot to lot release by the Regulatory Authority of the Country of Origin. (Category-II)
5	Name of three Countries where the product is marketed.	For Category-I & II
6	Summary Information of the plasma pool: Source of Plasma used for manufacture of the Batch. Period of collection of plasma. Certificate of plasma origin specifying compliance	For all categories of products.
7	Method of Fractionation	Products that are indigenously manufactured (Category-III) Products that are under contract Plasma Fractionation Programme. (Category-IV)
8	Method of viral Inactivation/ removal	For all categories of products
9	Certification by the manufacturer for GMP compliance and compliance to specifications as per IP2007	For Category-III
10	Batch Release Certificate from fractionation center.	For Category-IV

 

Expansion of Activities

Laboratory will take up the quality control testing of the following Blood Products

1. Human Normal Immunoglobulin (IgG) for intravenous use
2. Coagulation Factor-VIII
3. Coagulation Factor-IX

Scientific Links
 
I) National:-
   

1. Indian Pharmacopoeia Commission
2. Central Drugs Standard Control Organization (CDSCO).
3. National Accreditation of Board for testing and calibration of laboratories (NABL).
4.  

II)International:-
 

1. National Institute for Biologicals Standards and Control NIBSC), UK.
2. International Conference on Harmonization (ICH).
3. Center for Biologic Evaluation and Research (CBER) USA.
4. World Health Organization (WHO).
5. Food and Drugs Administration (FDA), USA