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Assignment 7 - Nandini Sinhal

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26 views

Assignment 7 - Nandini Sinhal

Uploaded by

nandinisinhal01
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Assignment – 7

Nandini Sinhal

College of Science, Northeastern University

BIOT6290 : Foundations in Quality

Salli Cheever

NUID – 002290983

Module 7

October 20, 2024


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Let’s consider a change to the stopper rubber/elastomer material as outlined in Table A of the

FDA guidance document. Here’s a breakdown of the necessary steps to document, justify, de-

risk, validate, control, and implement this change, applying key principles like risk management,

Quality by Design (QbD), and cGMP:

1. Documentation Needs (Engineering Change Notice):

You would document the proposed changes using the Engineering Change Notice (ECN)

template you provided. This ECN would ensure all aspects of the change are considered and

captured. Specifically:

 ECN Type: New Component or Existing Component change

 Documents Affected: Material specifications, purchasing specifications, and

manufacturing/inspection specifications related to the stopper.

2. Risk Management (QbD & Risk Assessment):

 Conduct a risk assessment per ICH Q9 to identify and mitigate risks associated with the

new stopper material. This would involve evaluating the impact on product quality,

safety, and efficacy. Include considerations for extractables and leachables, container

closure integrity, and potential changes in interaction with the drug product (e.g.,

adsorption or contamination).

 Risk Mitigation Strategy: Outline specific strategies, like tighter control of material

supply, ensuring compatibility with sterilization methods, and additional quality control

tests.
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3. Validation:

 Conduct validation studies to ensure the new stopper material maintains sterility and

product integrity, including container closure integrity testing (CCIT), accelerated

stability and real-time stability data.

 Include batch testing data (release and stability) in both normal and extreme conditions to

confirm there is no adverse effect on the product.

 Validate that the new stopper material complies with USP <381> Elastomeric Closures

for Injections to ensure safety and performance.

4. Control & Compliance (cGMP):

 Ensure QA Approval is obtained for all new or modified documents, processes, and

materials.

 Change Control System: Track all document updates through a formalized change

control system. Any new stopper material will need to be evaluated for impacts on SOPs,

validation protocols, and batch records.

 Ensure Part 11 compliance for any electronic records involved in tracking these

changes.

5. Submission to the FDA:

 Based on the guidance, this change would likely require a Prior Approval Supplement

(PAS) submission to the FDA, as changes in stopper material are considered higher risk.

 You’ll need to include all the supporting data, risk assessments, and validation results in

your submission.

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