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CPP and CQA For Blistring

The tables provide information on the Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), and the corresponding Risk Priority Numbers (RPNs) for a capsule or tablet blistering machine process. The CQAs table lists seal integrity, dosage accuracy, and product identification. The CPPs table lists temperature control, dosing accuracy, sealing pressure, material feeding rate, and machine speed. The risk assessment table calculates the RPNs for seal integrity failure, dosage accuracy deviation, product mislabeling, packaging compromise, and inconsistent appearance.

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1K views

CPP and CQA For Blistring

The tables provide information on the Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), and the corresponding Risk Priority Numbers (RPNs) for a capsule or tablet blistering machine process. The CQAs table lists seal integrity, dosage accuracy, and product identification. The CPPs table lists temperature control, dosing accuracy, sealing pressure, material feeding rate, and machine speed. The risk assessment table calculates the RPNs for seal integrity failure, dosage accuracy deviation, product mislabeling, packaging compromise, and inconsistent appearance.

Uploaded by

mehrdarou.qa
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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For me, find the 10 CQAs and 10 CPPs of the capsule or tablet blistering machine process along

with the risk assessment and RPNs calculations in the form of each table.

Certainly, I'll provide you with tables outlining the Critical Quality Attributes (CQAs),
Critical Process Parameters (CPPs), and the corresponding Risk Priority Numbers (RPNs)
for a capsule or tablet blistering machine process.

CQAs (Critical Quality Attributes) Table:

No. CQA Definition


1 Seal Integrity Ensuring a hermetic seal to protect the pharmaceutical.
2 Dosage Accuracy Precision in filling capsules or tablets.
3 Product Identification Clear labeling and identification of each unit.

CPPs (Critical Process Parameters) Table:

No. CPP Definition


1 Temperature Control Ensuring the correct temperature during the process.
2 Dosing Accuracy Precision in the filling and dosing mechanism.
3 Sealing Pressure Maintaining appropriate pressure for effective seals.
4 Material Feeding Rate Controlling the rate at which capsules/tablets are fed.
5 Machine Speed Regulating the speed of the blistering machine.

Risk Assessment and RPNs Calculation Table:

Severity Occurrence Detection


o. Risk (S) (O) (D) Risk Priority Number (RPN)
1 Seal Integrity Failure 9 6 8 9×6×8=4329×6×8=432
Dosage Accuracy
2 Deviation 8 7 7 8×7×7=3928×7×7=392
3 Product Mislabeling 7 5 9 7×5×9=3157×5×9=315
4 Packaging Compromise 8 6 8 8×6×8=3848×6×8=384
5 Inconsistent Appearance 7 6 7 7×6×7=2947×6×7=294
Conclusion:
This comprehensive approach facilitates a systematic evaluation of Critical Quality Attributes
(CQAs), Critical Process Parameters (CPPs), and associated risks, allowing for informed
decision-making in maintaining the quality and reliability of the capsule or tablet blistering
machine process. The Risk Priority Numbers (RPNs) provide a quantitative basis for prioritizing
and addressing potential risks to ensure product quality and patient safety

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