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)

    4.1. Method (S) followed

   4.2. Tests conducted on final concentrate:

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