Batch release to save the transit time

GOOD DOCUMENTATION PRACTICE (GDocP) DEVIATION AND DISCREPANCY HANDLING
1

Can we release the batch under deviation, If micorbial analysis not completed to save transit time.

sachendra

2

[quote=sachendra]Can we release the batch under deviation, If micorbial analysis not completed to save transit time.

sachendra[/quote]

You can release the batch under following conditions,

  1. The microbial analysis shall be completed before receipt of the material at customer end.
  2. The microbial analytical results COA shall be scanned to prior to material use.

The following criteria shall be considered for taking decision to release the batch with out microbial testing.

  1. The previous results [Trend] of microbial analysis evidence.
  2. The used water in the final process should be free from microbial load.
  3. The final process area should be in controlled area [From viable contamination]

Based on the above conditions you can decide for release.

Thanks and regards

3

Dear Mr Prasad,
Is there a regulatory document ( as per Drug and cosmetic act 1940) which states that we can release the batch for transit wherein the microbiological testing is underway.

Rajan Moily

4

No, you cannot release a batch when Microbial results or tests are still underway.

These reason is that these microbes get stressed and their growth patterns will change a bit until suitable medium and temperature will be available for their growth.

We have to wait until a clear singnal or a Certificate of Microbial Analysis is released by Quality unit.
Theere were days in post 1980’s such events took place where they were released. Once the laws got tighter and industry came to know about ill effects of micribial flora and especially the spore formers the Regulators and Industry both do not take chance.

In Oral dosage forms it might cause a Gastro Instestinal problem and in parenterals it might cause a sever microbial and endotoxin shock.

5

Hi,

Actually these cases in technical terminology called as “Perametric Release” & Acceptable by the Regulatory agencies. There are certain terms & conditions for perametric release which needs to be fulfilled before release in open market or for further processing.

Yes, concept of perametric release was introduced in early 1980’s and FDA had published CPG over the same. Several other literature on perametric release is available (APIC, EMEA, PIC/s etc) & one can refer the same.

As Mr. Prasad suggested few criteria for assessment…I will suggest prepare a assessment document for perametric release & if your conditions got fulfilled as an outcome of assessment…get rolled out a SOP & checklist for the same.

Happy Reading !