Sample Receipt Sera Panels National Reference Standards

SUMMARY OF FINISHED PRODUCT FOR STREPTOKINASE (BULK)

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

Production Protocol

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

 

2.  Name/strain of the 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)

4.0. Concentration of material:

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. 1.

Physical tests

Hydrogen ion concentration

 

 

  1. 2.

Purity tests

SDS-PAGE

 

 

  1. 3.

Biological tests

Streptokinase activity claimed

 

 

Specific activity assigned

 

 

Streptodornase activity

 

 

Streptolysin activity

 

 

  1. 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):

5.0. Identification number or lot or batch number assigned:

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

  1.  

Streptokinase content

 

 

  1.  

 

 

 

  1.  

 

 

 

  1.  

 

 

 

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.  1.

Description

 

 

  1.  2.

Identification

 

 

  1.  3.

pH

 

  1.  4.

Loss on Drying

 

  1.  5.

Streptodornase Activity

 

 

  1.  6.

Streptolysin Activity

 

 

  1.  7.

Potency

 

 

  1.  8.

Bacterial Endotoxin

 

 

  1.  9.

Abnormal Toxicity

 

 

  1.  10.

Sterility

 

 

  1.  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: 

 

    1. 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:

 

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