OBJECTIVE: To lay down the procedure for In process Control of Capsule Manufacturing.
SCOPE: This SOP covers the responsibility and procedure for In process control during capsule manufacturing.
RESPONSIBILITY: In process Quality Assurance Executive/Officer.
ACCOUNTABILITY: Quality Assurance Manager.
PROCEDURE: Carry out line clearance at each stage of operation prior to start up of the activity as per SOP.
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 BMR up to the previous stage of that activity.
Verify the RH, temperature and pressure differential of Blending room, which should be within specified limit and record the observation in Annexure II for RH and temperature.
Check the integrity of sieve visually used for sifting randomly in a shift.
Withdraw the intermediate samples after completion of blending following SOP of sampling procedure..
Submit the sample along with sample request to Quality Control for analysis.
Ensure that blend is analyzed and released before start up the filling.
Check that the bin to be used for filling 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 all the status labels are pasted on the machine/containers/bin.
Ensure that all parameters of capsule filling are being checked by production at start up of filling and the results of the same are recorded in BMR and the results are within specified limit.
IN PROCESS OBSERVATION:
Check the RH, temperature and pressure differential of the capsule filling room and ensure that these are within specified limit. Record the observation for RH and temperature.
Carry out following In process checks at regular interval of 02 hours.
- Individual Weight Variation
- Group Weight of 20 capsules
- Locking Length of 05 capsules
- Disintegration Time of 06 capsules
For checking Individual weight variation collect 20 filled capsules and take the weights of individual capsule.
In case the weight of capsule is found upper/lower than the specified limit as per In-process specifications, segregate the containers filled between previous and current check. Randomly collect sample of 20 capsules from each container and weigh.
Clear the container if sample passes the limit of weight variation. Recheck if any of the container found having weight variation of capsules out of limits.
If the capsule from container in question fails second time, treat those capsules of container as recoverable, which were filled 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 capsules are found within specified limit then allow for further filling.
Collect 06 capsules from continuous run and check Disintegration Time using Disc in all the cavities of the basket of DT machine. All the capsules shall disintegrate in the specified time.
If residue of the any capsule remains on the screen and it consist of a soft mass having no palpably firm or only fragments of shell (capsules) or if fragments of shell adhere to the lower surface of the disc, allow continuing the filling.
Write the disintegration time in BMR of capsules at which no residue of powder remain on the screen, but the fragments of shell may adhere to the lower of the disc.
If the residue of the any capsule remain on the screen and it consist hard mass having palpable firm, stop the production.
Get the necessary action done as reset the machine and recollect the capsules as stated above and again recheck the disintegration time. If it passes then allow the filling to continue.
Treat those capsules as ‘Recoverable’, which were filled between the last check (By Production or IPQA whichever was latest) and present check.
Collect 05 capsules from continuous run and check Locking length with the help of digital Vernier Calipers. The locking length of the capsules shall be within specified limits.
Ensure that all the parameters are being checked by production at a regular interval are found within specified limit and the same has been recorded in BMR.
Collect the samples of bulk capsules after completion of the filling and submit it to Quality Control for analysis.
Check the results of analysis before clearance for packing and after assurance affix approved label on the trolleys of the filled containers.
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. Also get the approval of QA for deviation.
SOP: Standard Operating Procedure
BPR: Batch Packing Record
QA: Quality Assurance
DISTRIBUTION LIST :
Quality Control Departments
HISTORY OF REVISION:
|Version Number||Effective Date
|Reason for Revision
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube