Sample Receipt

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National Reference Standards

STREPTOKINASE (INJECTION)

A) Trade Name:
B) Non-propriety / Common name:
C) Batch No:
      Finished product (final lot):
      Finished bulk:
D)Total number of containers:
E) Volume per container:
F) Date of expiry:
G) Date of manufacture:
H) Storage temperature:
I) Production/ Import license number & date valid up to:
J) Name and address of manufacture:
K) Distributor/ Dealer:

Production Protocol

1. 1.Details of starting materials (Inoculum):
1. 1.1 Source of Master seed:

 

     

2.1. Date of lyophilization of seed:
      2.2. Volume of broth used for initial scale up:
      2.3. Details of fermentation media used and its composition:
      2.4. Incubation temperature, pH, time (Special conditions if any maintained):
      2.5. Details of tests taken up for culture seed before going to production:

   

Test Conducted	Method	If any kit used	Kit Manufacturer

      2.6. Certificate of approval if the culture seed has been imported:

3 . Details of the Intermediate product/ Processes (which ever is applicable):
(These tests are to be performed to keep a check on the process integrity by doing intermittent sampling from the fermenter).
3.1.Test for protein content:
3.2. Cell density:
3.3.Broth culture filtered through:
3.4.Membrane filters used and Sieve size:

3.5. Product yield: 
3.6.Probable process impurities:
3.7. Type and limits of impurities (Protein/DNA/ if any)

 

  4.1. Method (S) followed

S.No	Method (S) followed	Details of method	Initial  concentration	Final Concentration

 

 

 

 

4.2. Tests conducted on final concentrate:

S.No	Test Conducted	Method/ Technique	Result	If Kit used , details of the kit Manufacturer
1.	Physical tests	Hydrogen ion concentration
2.	Purity tests	SDS-PAGE
3.	Biological tests	Streptokinase activity claimed
		Specific activity assigned
		Streptodornase activity
		Streptolysin activity
4.	Safety tests	Bacterial Endotoxin content
		Abnormal toxicity
		Sterility

4.3. Details of Purification steps and number of repetitions (If any)
4.3.1. Hydrophobic Interaction chromatography.

4.3.2. Ion Exchange Chromatography.

4.3.3. Desalting.

4.3.4. Other methods followed (If any):

5.1       Quantity:
5.2       Predicted time (days) of getting yield:
5.3       Storage temperature:
5.4       Storage time:
5.5       Approved storage period:

6.0. Blending of final bulk:
6.1. Composition of final bulk:        

S.No	Component	Quantity added	Final concentration
	Streptokinase content

6.2. Batch No:                                                                        
6.3. Quantity:
6.6. Date of blending:
6.7. Final bulk container:                                
6.8. Identification code:                                  
6.9. Quantity

7.0. Test (s) on final bulk as per respective pharmacopoeial specifications:

S.No	Parameter	Specification	Results
1.	Description
2.	Identification
3.	pH
4.	Loss on Drying
5.	Streptodornase Activity
6.	Streptolysin Activity
7.	Potency
8.	Bacterial Endotoxin
9.	Abnormal Toxicity
10.	Sterility
11.	Purity SDS-PAGE

                    
         7.1. Specific activity---------- (IU/mg)  
           7.2. Details of Lyophilization conditions:
           7.3. Moisture content:
           7.4. Details of containerization: 

           

8.1. Composition of final batch:

S.No	Test Conducted	Method/ Technique	Result	Acceptance criteria
1.	Identification
2.	Physical parameters	Clarity
		Particulate matter
		Hydrogen ion concentration
3.	Purity tests	SDS-PAGE
4.	Biological tests	Streptokinase activity claimed
		Specific activity assigned
		Streptodornase activity
		Streptolysin activity
5.	Safety tests	Bacterial Endotoxin content
		Abnormal toxicity
		Sterility

2. Certificate of Production:

 

Certification by qualified person taking the overall responsibility for production and control:

I here by certify that_________________________(name of the product) batch number_______________ was manufactured at ______________________and tested at ____________________according to the procedures approved by the competent authorities and complies with the official monograph.

Signature:
Name:
Date:
Official Stamp:
Authorized signatory: