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How to write a Validation Risk Management Plan for Equipment

E

eva_deng

#1
these equipments include HVAC, purified water, water for injection and manufacturing machine, packaging machine.

PS, do i also need to create a risk assessment for each equipment?

thanks in advance

eva
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
these equipments include HVAC, purified water, water for injection and manufacturing machine, packaging machine.

PS, do i also need to create a risk assessment for each equipment?

thanks in advance

eva
Hi Eva,

I can't provide too many answers, but I can point out some questions worth asking :)

The first one is what is your target market? If it's the USA, then the FDA has some guidance regarding implementation of process validations (look under the QSR manual). Otherwise, you may want to consult this resource:

http://www.ghtf.org/documents/sg3/sg3_fd_n99-10_edition2.pdf

Second question is what type(s) of product(s) are you making and what are the associated risks? In general, you should validate all processes where verification of the outcome (the output meets the specified requirements) by consequent testing / measurement / inspection is either impossible, impractical or undesired for whatever reason. I would guess that your HVAC systems, water treatment systems and sterile packaging processes would fall under this definition. The rest is too dependent on the product details and other specific circumstances.

Risk assessment can be a powerful tool in determining what to look at in the validation. Naturally you would want to focus on the higher risks.

Cheers,
Ronen.
 

somashekar

Staff member
Super Moderator
#3
these equipments include HVAC, purified water, water for injection and manufacturing machine, packaging machine.

PS, do i also need to create a risk assessment for each equipment?

thanks in advance

eva
I see two things here.
1. Validation of processes
2. Risk management of medical device.

I think you are referring to the validation of processes
Perhaps your pure water treatment process needs to be validated.

Please come back and tell us more details further.
 
E

eva_deng

#4
we are a contact lense and lense care product manufacturer.It is a high risk product and we want to meet U.S FDA requirements.All the consultants told us we should write a risk assessment to manage all the equipments validation. I just don't know how? I am new in validation aspect:eek:.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
we are a contact lense and lense care product manufacturer.It is a high risk product and we want to meet U.S FDA requirements.All the consultants told us we should write a risk assessment to manage all the equipments validation. I just don't know how? I am new in validation aspect:eek:.
Hi Eva,

With regards to process validations, go here:

http://www.fda.gov/MedicalDevices/D...dicalDeviceQualitySystemsManual/ucm122439.htm

and just follow step by step.

Please note that you also have to meet all and any special controls that your products are subject to, on top of the FDA general controls which apply to all devices. Do you have a list of applicable FDA product codes?

If you have any further questions, you can post them here or send me a private message.

Best of luck,
Ronen.
 

jkuil

Quite Involved in Discussions
#6
The assessment for the GxP Risk needs to address the following questions:
  • Does this system require validation?
  • How much validation is required for this system?
  • What aspects of the system or process are critical to product and patient safety?
You can replace system by change, because this risk assessment needs to performed for every change.

Good Engineering Practices introduced the site impact assessment by which the impact on product quality can be assessed. Systems are assessed as to their impact on product quality by answering the following questions:
Does the system come in contact with the product (including systems for air quality)?
  • Does the system provide an excipient or produce an ingredient or solvent?
  • Is the system used in cleaning or sterilizing?
  • Does the system preserve product status?
  • Does the system produce data evaluated to accept or reject product?
  • Does the system control or manipulate the process in such a way as to affect product quality without independent verification of the control system performance (PLCs, DCS, Loop Controllers)?
Systems are identified as “Direct”, “Indirect” or “No impact” systems. Only direct impact systems require validation. The systems mentioned in your question would classify as direct impact systems. These systems you break down in components and again identify which component has an impact on product. Only for the component which do have an inpact on product you perform an risk assessment. You can apply common risk assessment tools like FMEA, HAZOP, FTA to identify and quantify the risks.
 
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