The purpose of the blending validation
The purpose of blending is defined as the process of combining API of different batches within the same specification to produce a homogeneous API with large batch size. This validation is applicable only to mixing the different batches of same API to increase the batch size of drug substance. In-process mixing of fractions from single batch (e.g. collecting several centrifuge loads from a single crystallization batch) or combining fractions from several batches for further processing is considered to be part of the production process and it is not considered to be bending validation.
Blending validation shall be performed in following criteria
Ø Blending of small batches to increase batch size.
Ø Blending of tailings (i.e. relatively small quantities of isolated material) from batches of the same API
to from a single batch.
Ø Change in validated blending batch size.
Minimum three consecutive API batches shall be selected for blending validation.
Following parameters shall be similar in selected blending validation batches:
Ø Batch Size of blend batch
Ø Approved individual batches should released with similar specification
Ø Equipment to be used for blending
Ø Blending process e.g. RPM for blender
Ø Blending time
The purpose of blending is defined as the process of combining API of different batches within the same specification to produce a homogeneous API with large batch size. This validation is applicable only to mixing the different batches of same API to increase the batch size of drug substance. In-process mixing of fractions from single batch (e.g. collecting several centrifuge loads from a single crystallization batch) or combining fractions from several batches for further processing is considered to be part of the production process and it is not considered to be bending validation.
Blending validation shall be performed in following criteria
Ø Blending of small batches to increase batch size.
Ø Blending of tailings (i.e. relatively small quantities of isolated material) from batches of the same API
to from a single batch.
Ø Change in validated blending batch size.
Minimum three consecutive API batches shall be selected for blending validation.
Following parameters shall be similar in selected blending validation batches:
Ø Batch Size of blend batch
Ø Approved individual batches should released with similar specification
Ø Equipment to be used for blending
Ø Blending process e.g. RPM for blender
Ø Blending time
Extensive analysis of blending
validation batches shall be done for critical attributes (e.g. particle size distribution, bulk
density and tap density and assay during the validation. After completion of bending
validation, blending batches evaluated against the approved Finished product specification
as per in-put batches.
Blending validation shall be
considered as successful after satisfactory completion of six months stability data for Accelerated Condition
(40° ± 2°C / 75% ± 5% RH) and Long Term Condition (25°C ± 2°C / 60% ± 5% RH) of
selected batches.
Blending validation report shall
be prepared after completion of three consecutive blending
Batches. In case,
there is no requirement for three batches; interim blending validation report
shall be prepared based on successfully completion of one or two batches. The
final report shall be prepared when as completion of third batch. If changes in blending batch size, RPM and blending
time then revalidation for blending shall be performed as per blending
validation.
Thanks it is very useful information an i like it.
ReplyDeletei have one doubt, i proposed three different batch sizes based on blender capacity 20%,50% and 80%. is it acceptable to validate the process?
ReplyDelete