Requalification/Revalidation Activities - Dietary Supplement Manufacturing Equipment

O

Omar D

Hello,
I am currently working on requalification activities for manufacturing equipment. Our industry (Dietary supplements) is regulated by FDA CFR 21 part 111 and the need for validation is not required. However, due to product distribution in Australia, we are required to qualify/validate our manufacturing equipment/processes. During our last Audit, the Australian (TGA- Therapeutic Goods Administration) auditor recommended requalification(s) for previously qualified equipment. Our Validation Master Plan mentions that periodic assessments (based on a risk/impact assessment) will be conducted to ensure the equipment or processes are still in a state of control. However, the auditor requested objective evidence that the assessments or Re-qualifications are conducted. I developed and executed a few and short Re-qualification protocols for blending equipment. I know that a “documented assessment” can be sufficient evidence to justify the equipment/process is in a state of control. Most of our manufacturing equipment is well maintained and no adverse events have been reported in the past two years (most equipment were qualified in the last 2-3 years).
The question is, are there any guidelines, templates or suggestions you can share for documenting a “risk/impact assessment” in order to avoid generation of re-qualification protocols (given that all equipment is in a state of control)?
Any comments/suggestions will be greatly appreciated.
OD
 

Stijloor

Leader
Super Moderator
Re: Requalification/Revalidation Activities - Dietary Supplement Manufacturing Equipm

A Quick Bump!

Can someone help Omar?

Thank you very much!

Stijloor.
 
O

Omar D

Re: Requalification/Revalidation Activities - Dietary Supplement Manufacturing Equipm

Can someone help with the topic below?
Your suggestions will be greatly appreciated.

Hi, I am currently working on requalification activities for manufacturing equipment. Our industry (Dietary supplements) is regulated by FDA CFR 21 part 111 and the need for validation is not required. However, due to product distribution in Australia, we are required to qualify/validate our manufacturing equipment/processes. During our last Audit, the Australian (TGA- Therapeutic Goods Administration) auditor recommended requalification(s) for previously qualified equipment. Our Validation Master Plan mentions that periodic assessments (based on a risk/impact assessment) will be conducted to ensure the equipment or processes are still in a state of control. However, the auditor requested objective evidence that the assessments or Re-qualifications are conducted. I developed and executed a few and short Re-qualification protocols for blending equipment. I know that a “documented assessment” can be sufficient evidence to justify the equipment/process is in a state of control. Most of our manufacturing equipment is well maintained and no adverse events have been reported in the past two years (most equipment were qualified in the last 2-3 years).
The question is, are there any guidelines, templates or suggestions you can share for documenting a “risk/impact assessment” in order to avoid generation of re-qualification protocols (given that all equipment is in a state of control)?

Any comments/suggestions will be greatly appreciated.
OD
 
O

Omar D

Requalification/Revalidation Activities - Dietary Supplement Manufacturing Equipm

Can someone help with the topic below?
Your suggestions will be greatly appreciated.

Hi, I am currently working on requalification activities for manufacturing equipment. Our industry (Dietary supplements) is regulated by FDA CFR 21 part 111 and the need for validation is not required. However, due to product distribution in Australia, we are required to qualify/validate our manufacturing equipment/processes. During our last Audit, the Australian (TGA- Therapeutic Goods Administration) auditor recommended requalification(s) for previously qualified equipment. Our Validation Master Plan mentions that periodic assessments (based on a risk/impact assessment) will be conducted to ensure the equipment or processes are still in a state of control. However, the auditor requested objective evidence that the assessments or Re-qualifications are conducted. I developed and executed a few and short Re-qualification protocols for blending equipment. I know that a “documented assessment” can be sufficient evidence to justify the equipment/process is in a state of control. Most of our manufacturing equipment is well maintained and no adverse events have been reported in the past two years (most equipment were qualified in the last 2-3 years).
The question is, are there any guidelines, templates or suggestions you can share for documenting a “risk/impact assessment” in order to avoid generation of re-qualification protocols (given that all equipment is in a state of control)?

Any comments/suggestions will be greatly appreciated.
OD
 
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