INPROCESS CONTROL DURING TABLET MANUFACTURING
OBJECTIVE: To lay down the procedure for In process Controls during Tablet Manufacturing.
SCOPE: This SOP shall be applicable for in process controls during tablets manufacturing.
RESPONSIBILITY: In process Quality Assurance Executive/Officer.
ACCOUNTABILITY: Head Quality Assurance.
PROCEDURE:
Carry out line clearance at each stage of operation prior to start up of the activity as per SOP.
GRANULATION:
Check & ensure that machine equipment /Accessories bears the machine / bin/ container status label of current batch as mentioned in SOP.
Verify that all the entries are completed in Batch Manufacturing Record upto the previous stage of that activity.
Verify the Rh, temperature and pressure differential of granulation room, which should be within the specified limit and record the observation. For RH and temperature.
Check integrity of sieve visually used for sifting randomly in a shift.
Withdraw the intermediate sample after completion of blending following SOP of sampling procedure.
Submit the sample to Quality Control Lab for analysis accompanied by Test Request Form.
COMPRESSION:
Ensure that blend is analysed and released before start up of the compression and the ‘Approved’ label affixed on IPC.
Check that the bin to be used for compression bears the product status label and is fixed on the machine at gravity feed receptor in such a way that there is no spillage of powder.
Ensure that the status label is affixed on the machine /container/ bin.
Ensure that all parameters of compression are being checked at startup of compression and results are within specified limits.
COATING
Ensure that compressed tablets are analyzed and released before they are taken for coating.
Ensure that correct coating solution is being used for coating.
The weight of the tablet after coating shall be within specified limits.
INPROCESS CHECKS:
Check the Rh, temperature and pressure differential of the granulation, compression, coating, inspection and primary packing room and ensure that these are within specified limit. Record the observation.
FOR COMPRESSION:
Carry out following In process checks at a frequency specified in the Batch manufacturing Record..
- Gross weight of 20 tablets
- Disintegration Time
- Friability
- Individual weight variation of 20 tablets.
- Hardness
- Thickness
- Width
- Length
- Dispersibility (if applicable)
For checking Individual weight variation collect 20 compressed tablets from a continuous run through discharge chute from each side(For double rotary) and take the weights of individual tablets and record weights in Batch Manufacturing Record.
In case the weight of tablet is found upper/lower than the specified limit as per In process specifications, segregate the containers filled between previous and current check as per failure of side of machine. Randomly collect sample of 20 tablets from each container and take the weight of individual tablet.
Clear the container if sample passes the limit of weight variation. Recheck if any of container found having weight variation out of limit.
If the tablets from container in question fail second time, treat those tablets as ‘Recoverable’, which were compressed between the last check (By Production or IPQA whichever was latest) and present check.
Reset the machine and recollect the sample as stated above and check.
If all the 20 tablets are found within specified limit then allow for further compression.
Collect 06 tablets from continuous run from each side and perform Disintegration Test as per SOP.
If residue of the any tablet remains on the screen having palpably firm (i.e. hard mass), then stop the production and get the compression force of the machine adjusted.
Recheck for DT with another six tablets and if it passes then allow continuing the compression.
Treat those tablets as ‘Recoverable’, which were compressed between the last check (By Production or IPQA whichever was latest) and present check.
Perform Friability test as per SOP.
Ensure that all the parameters are being checked by production at a regular interval are within specified limits and the same has been recorded in BMR.
Collect the samples of compressed tablets after completion of the compression and submit it to Quality Control for analysis along with Test Request Form.
Check the results of analysis for compliance before clearance for packing/coating.
Verify that Yield reconciliation is being done and found correct at the end of each operation of blending & compression.
If any deviation is observed during in process checks, investigate the cause of deviation and ensure that deviation will not affect the quality of product. Get the approval of QA Manager for deviation. Mention the same in the Batch manufacturing Record.
FOR COATING:
Carry out following In process checks at a frequency specified in Batch Manufacturing Record.
- Appearance
- Gross wt of 20 tablets
Ensure that all the parameters are being checked by production/IPQA at regular interval are within specified limits and the same has been recorded in BMR.
Collect the samples after complete coating lot wise (If applicable) and check the appearance and gross weight. It should meet the specified parameters.
If it not conforming the limits then, ask to production for corrective action and make deviation if required.
Collect the samples of coated tablets after completion of the coating and submit it to Quality Control for analysis along with Test request form.
Verify that Yield reconciliation is being done and found correct at the end of each operation of granulation, compression, coating, inspection.
If any deviation is observed during in process checks, investigate the cause of deviation and ensure that deviation will not affect the quality of product. Get the approval of QA Manager for deviation.
