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. Details of starting materials (Inoculum):
    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:

   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:

   4.2. Tests conducted on final concentrate:

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:        

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

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

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

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: