The purpose of this standard Operating Procedure (SOP) is to lay down a procedure for the guidelines for checking of the pellets before Bulk packing and Capsules filling.
This procedure is applicable for guidelines for checking of the pellets before Bulk packing and Capsules filling at manufacturing facility of Pharmaceutical Industry
Before bulk packing or Capsules filling, visual checking of the pellets should be done for the following:
The shape of the pellets should be spherical and uniform.
The size of the pellets should be such that no unusual bigger pellets are observed, than that of the standard size as specified in the respective batch manufacturing record for the product.
The pellets should be free from agglomerates, broken pellets and fines.
The pellets should be free from Husks.
The pellets should be checked for any lumps / cake formation.
In case of any abnormal observation, resizing must be done through the sieves as specified in the BMR of respective product to remove agglomerates, broken pellets, fines or husks. The same should be recorded.
Check the shade of the pellets and ensure that there is no shade variation.
As per SOP on employee Training
As per SOP OF SOP