Qvents Template

Excipient Risk Assessment Ongoing Risk Review

 

 

Excipient Name

 

Material Code

 

Excipient Manufacturer

 

Assessment Document Number

 

Material Origin (Animal / Vegetable / Mineral / Synthesis /Others

 

Original Excipient Risk Assessment Document Reference

 

Review Period

 

Review Date

 

 

 

Element of GMP

Impact / Risk on drug product categorization

Level of Impact

Number of product defects connected to batches of excipient received;

Low: Nil to One, positive resolution of issue

Medium: > 1 but less than 1% of batches, positive resolution of the issue

High: >1%, resolution pending

 

Type / severity of product defects

Low: Not impacting CQAs

High: Impacting CQAs of drug product and / or BA / BE attributes of the product

 

Monitoring and trend analysis of excipient quality;

Low: Consistent quality, low variability on CQAs of excipient quality parameters

High: High variability on CQAs of excipient quality parameters

 

Loss of relevant quality system and/or GMP certification of excipient manufacturer;

Low: All systems and certificates maintained

High: Loss or suspension of GMP / Quality system certifications

 

Trends in drug product quality attributes connected to excipient used

Low: No emerging trends, drug product quality trend is consistent on parameters that can be impacted by excipient

High: Emerging trends, high variability on drug product quality / performance attributes that can be connected to excipients

 

Organizational, Procedural or Technical/ process changes at the excipient manufacturer;

Low: If no changes or changes are administrative

High: Management changes, Process changes, specification changes

 

 

 

Excipient Control Strategy

S.No

Strategy

Control strategy revision guide #

Control Strategies - Conclusion
  1.  

Acceptance based on COA and documentation support

·   Maintain status is impact on drug product defects, severity of defects are Low, quality trend of excipient is consistent, GMP certifications are maintained.

·   Move from strategy 1 to 2 or 3 if there are major process or technical changes

·   If Impact is Medium move to control strategy 2 or 3

 
  1.  

Acceptance testing – Every Lot

 

·   Maintain status If impact on CQAs, composition risk, variability risk, Manufacturer reliability risk is High,

·   If excipient impact on drug product CQAs, functional attributes, BA / BE risk, composition risk, daily intake risk, excipient variability risk, manufacturer reliability risk is High

·   Move from strategy 1 or 2 to 2 or 3 if there are major process or technical changes

·   Move from Control strategy 1 and 3 to 2 if impact on drug product defects, severity of defects are High, quality trend is highly inconsistent. GMP certification status is changed

 
  1.  

Acceptance testing – Periodic / Skip testing

·   Maintain status if impact on drug product defects, severity of defects are Low, quality trend of excipient is consistent, GMP certifications are maintained.

·   If Impact is Medium move to control strategy 2 or 3 from 1

·   Move from control strategy 1 or 2 to 2 or 3 if there are major process or technical changes

 
  1.  

Microbial testing

·   Maintain status If Viral safety risk, Microbial / Endotoxin contamination risk is High to Medium

·   Introduce if there are microbial testing failures of drug product connected to excipient.

 
  1.  

Prequalification audit

·   Not applicable

 
  1.  

Prequalification audit and routine audits.

·   Maintain periodic audits if sterility risk is High

·   Introduce periodic audits if there is loss or discontinuation of GMP certificate

 
  1.  

Unacceptable

Consider change to Unacceptable / Discontinuation of excipient if:

·   impact on drug product defects, severity of defects are High, quality trend of excipient is highly inconsistent, GMP certifications are lost due to malpractices, deviations.

 

# - The list is indicative