Thrtee consucative batches

GOOD VALIDATION PRACTICE (cGVP)
#1

Hi Friends,

       As we know to complete the validation of particular product we take three consucative batches, after completion of validation batches we make summary and prepared a validation report. After completion of validation report only we sent it to market.

       My question is, 
 1. Is it necessary to sent the batches to market,  after completion of validation report of three consucative batches?
 2. If we have plan only one batch due to market requirement. Can we dispatch these batch in market?
 3. Can we take three consecutive batches on year basis to complete the the validation? i.e one batch in one year.

  Regards

 Prashant
#2

Dear Prashant,
1.It is up to you to send these batches to market. the batches are yours, they are used for validation purpose and can be used as a normal released batches.
2. yes.
3. It is as per the requirements of compliance of the approval you require. Generally three batches are required for validation purpose.
Dr.Pradeep Nagalkar
nagalkarp@yahoo.co.in

#3

Hi Prashant,

The term which can solve your problem is Concurrent process validation.
In this type of validation

  • You can go with one batch at a time for validation
  • prepare interim validation report &
  • release to market
  • remaining batches can be taken as per the availability.
  • At the end of all three batches prepare cumulative process validation report.

In this approach you need to have process validated at pilot scale or atleast at lab scale.
Rest everything is same as prospective process validation.

Satish Dange
satishd@drreddys.com

#4

Hi Prashat
You must refer ICH Q 7 having following statement,
“Concurrent validation can be conducted when data from replicate production runs are unavailable because only a limited number of API batches have been produced, API batches are produced infrequently, or API batches are produced by a validated process that has been modified. Prior to the completion of concurrent validation, batches can be released and used in final drug product for commercial distribution based on thorough monitoring and testing of the API batches”

#5

Dear all,

All of your above statements are very logical and the question I ask arises based on
Q7A guideline

-Is the Validation batch is similar size of commercial API batch & were there any seperation of lots before they are actually released?

  • Did you consider for shortest Batch production time validation?

These questions must be looked very keenly in API’s.

The release Criterion as Mr.Salve spoke is very logical
-Assay
-Mesh size or Compacted material
-Impurity profile
-Residual solvents (Again this is based on the buyer or Country you sell or Where this product ends in Formulation).
-Bacterial Endotoxins & Sterility of Bulk ( Sterile API)

Regards

#6

The number of batches chosen should be statistically based. Guidance on the num-ber of batches chosen can be found in United States vs. Barr Laboratories [812 F.Supp. 458, 474-475, 477 (D.N.J. 1993)].
The “general rule” from the above judgement is that between 20-30 batches is re-quired, but a firm can depart from this number provided it can support any such de-parture with statistical or other evidence that supports validation.

The above statements are from Official transcripts of ICH Q7A

#7

Some More Regulators comments :

The traditional approach to validation, including cleaning validation, is to perform a minimum of three validation runs. Of course, there is no statistical justification for three runs being acceptable. It is just something that pharmaceutical manufacturers and regulatory authorities have agreed on. In some regulatory documents (for example, PIC/S PI 006-03) it is written as a minimum of three runs. Based on previous communications from the FDA and the new FDA draft process validation guidance, the requirement for three validation runs is being replaced, probably by a statement that the manufacturer should decide on the required number of validation runs. Because of this, some manufacturers are changing their high level documents to read something like “three validation runs or a different number if appropriate.” That “different number” may be more than three or less than three.