sop for in process controls during granulation compression coating inspection

1.0 OBJECTIVE:
The objective of this SOP is:
1.1 To describe the procedure for monitoring the Quality of Tablets during granulation, compression, coating, inspection operation.

2.0 RESPONSIBILITIES:
2.1 Quality Assurance Officer / Executive shall be:
2.1.1 Responsible for assuring the quality of product during manufacturing process
2.1.2 Responsible for checking and compliance of in-process parameters.
2.1.3 Responsible to inform to Head Quality Assurance and Production in case of any major defect or defects of recurring

nature is observed and quarantine the whole material of in this period.

3.0 ACCOUNTABILITY:

Head – Quality Assurance

4.0 PROCEDURE:

4.1 Granulation
4.1.1 Give equipment and area clearance as per SOP on receipt of intimation form production for the same.
4.1.2 Ensure that status label of all raw material are with same detail as mentioned in Weighment sheet of BMR.
4.1.3 Ensure that sifting of materials is done as per process mentioned in BMR.
4.1.4 Ensure that dry mixing time of sifted material is maintained as per time mentioned in BMR.
4.1.5 In case Granulation by slugging
a. Ensure that slugging parameter are adjusted as per motioned in BMR
b. Ensure at regular interval that slugging parameter have been marinating throughout the slugging operation
c. Ensure that milling is done as process per mentioned in BMR
d. Ensure that lubrication of sized granule is done as process mentioned in BMR

4.1.10 In case of Wet Granulation:
a. Ensure that binder preparation is done as per process mentioned in BMR.
b. Ensure that wet mass is prepared as per process maintained in the BMR.
c. Ensure that inlet and outlet temperature during drying of wet granules are maintained as per the limit mentioned in BMR.
d. Ensure that LOD of dried granules is within limit mentioned in the BMR.
4.1.6 Check the yield of lubricated granules is with in the limit mentioned in BMR and certified the same in BMR when yield is in limit.
4.1.7 Ensure that all the container containing lubricated granules have yellow “ UNDER TEST “ label with all batch

detail and blue status label in between two ploy bags.
4.1.8 Collect sample of lubricated granules as per SOP for analysis on receipt of sample advice sheet from production for the same
4.1.9 Release the blend on receipt of QC result by signing on green release label.

4.2 Compression
4.2.1 Give equipment and area clearance as per SOP on receipt of intimation form production for the same.
4.2.2 After all the physical parameters have been set and the machine is in operation, collect sample as per SOP
4.2.3 Check the following parameters of above sample at interval about 2 hours as per their respective General Procedures (GP) and record it in the BMR.
a. Average Weight
b. Uniformity of weight
c. Disintegration
d. Friability
e. Hardness
f. Thickness
g. Uniformity of dispersion (for dispersible tablets)
4.2.4 Physical appearance, Colour, Embossing on tablet shall be checked during the same period.
4.2.5 The sample drawn for inprocess inspection shall be destroyed after performing the test as per SOP

4.2.6 Collect sample of finished product as per SOP on receipt of advice sample sheet from production for the same.
4.3 Coating
4.3.1 Give equipment and area clearance as per SOP on receipt of intimation form production for the same.
4.3.2 Verify the inlet temperature, outlet temperature, pan revolution per minute, spray rate, diameter of nozzle, spray cycle,

solution stirring, atomization air are set as per limit mentioned in BMR and sign in the BMR.
4.3.3 Check the yield of coated tablet is within the limit mentioned in BMR and certified the same in BMR when yield is in limit.
4.3.4 Collect finish sample as per SOP on receipt of advice sample sheet from production for it.

4.4 Inspection
4.4.1 Give equipment and area clearance as per SOP on receipt of intimation form production for the same
4.4.2 Check the quality of inspected tablets of each container.
4.4.3 Check the yield of inspected tablet is within limit mentioned in BMR and certified the same in BMR when yield is in limit.
4.4.4 Release the core /coated tablet for packing on receipt of release from QC.

5.0 REASON FOR REVISION:

This SOP is modified in order to be more effective in its responsibility, procedure and incorporation of schematic

diagram (Refer Annexure – 1) for better presentation.

6.0 TRAINING:
Trainer — Head – Quality Assurance
Trainee — Quality Assurance Officers
Period — One day

7.0 DISTRIBUTION:

Certified Copy No. 1 : Head of Department – Quality Control
Certified Copy No. 2 : Head – Plant Operations

Original Copy : Head – QUALITY ASSURANCE

8.0 ANNEXURE:

Annexure – 1 Schematic Diagram

9.0 REFERENCE:

In-house

ANNEXURE – 1

SCHEMATIC DIAGRAM