PROCEDURE FOR THE QUARANTINING OF INPROCESS MATERIAL:
In-process material (IPM) refers to any material that’s undergoing transformation or hasn’t reached its final finished product stage. It essentially to cover everything between the starting raw materials and the final packaged products.
Intimate to the Quality assurance to collect the sample for analysis through “Test Request Form” as per Format-I, where ever required.
Collect the Blend/tablet in prelabeled IPC / canister/ HDPE containers with double polybag and record the weights in BMR and label.
Tightly close the both polybags neatly and close the lid.
Clean the outer surface of IPC /HDPE/Canister with lint free cloth and transfer the same to the hold area.
IPQA shall provide the “APPROVED/REJECTED” label as per results of analysis. These labels shall be provided along with “COA” and same label shall be pasted in BMR.
Approved materials shall be transferred for further processing.
If the product is due for retesting, transfer the same product containers to the dedicated area and open the container in presence of IPQA for sampling against test requisition, enter the details in “Test request Form Details Register”.
The same test request form as per Format-I can also be used for sending Swab Samples.
The concerned executive has to fill all the relevant fields in “Test request form details register” as per Format-II. ‘Requested by’ column shall be signed by concerned production executive and ‘Sampled by’ column shall be signed by concerned IPQA executive. In case of swab samples ‘Sampled by’ column shall be signed by concerned QC executive. Maintain the “Test request form details register” in the respective areas.
PROCEDURE FOR NUMBERING OF THE TEST REQUEST FORM:
Numbering of the Test Requisition Form shall be given area wise with eleven characters.
Numbering of Test Requisition Form shall be as per follows: XXX/NNNN/YY
whereas first three characters indicates Area code,
followed by slash.
next four characters indicates serial numbers of test request form
followed by slash and
last two characters indicates the year.
E.g. GR1/0001/26. This number indicates that the first sample from the Granulation area1 in year 2026.
Area coding for production areas as follows:
For Granulation 1; area code shall be GR1 and Granulation 2; area code shall be GR2 and continues serially.
For Compression 1: area the area code shall be CM1, for compression 2 area the area code shall be CM2.
For Coating area 1: the area code shall be CO1 and continues serially.
For Blending area 1; code shall be BL1 and For Blending area 2; code shall be BL2 and continues serially.
For Inspection area 1; code shall be IN1 and For Inspection area 2; code shall be IN2 and continues serially.
For Bulk packing 1: area code shall be BP1 and continues serially.
For blister packing-1: area code shall be BL1, and continues serially.
Swab samples Test Requisition Form shall be recorded with same area code and same serial numbers for each respective area.
