Release of Deviation batch

[rdasaratharamireddy]

Dear Forum Colleagues,

During the manufacturing of product 'X' there was deviation filed as an equipment breakdown and alternative method used in particular step which is not part of either MFR or BMR and that equipment employs the purification of product 'X' , other method which used directly effects on product quality and efficacy.There is no previous data is available for such deviation. After preliminary evaluation it is decided to check impact on the product against specification. Similary, product met the predetermined specification which is defined by Compendia. My query is ,
1. shall the batch to be released or additional investigation shall be done on the product.
2. To release the batch shall i perform the validation with simulating the conditions?
or Batch can be disposed.


Please suggest.

Thanks in advance

Dasarath

[VINOD PADMAKAR KULKARNI]

If the deviation which is affecting the quality and efficacy of the product, you can quarntine the product. Perform the process validation & if it is ok, then only release the batch.Otherwise batch shall be considered for rejection if the devation happened cant be justified considering the quality impact.