Preparation for Product Validation Protocol

ctct61t · Aug 5, 2011

We are a research centre, and responsible for product development for a private company. Our design work has come to the stage of product validation phase. Neither our research centre nor the private company has GMP ISO 13485 certification.

We are engaing a GLP lab to do all validation tests for us. But we need to prepare validation protocol before the test. I'm not sure whether the validation protocol issue by our research center are validate to be used in either CE or FDA certification.

We are really worry about this, could any experts here can help me?

Thanks a lot... :frust:

Stijloor · Aug 8, 2011

ctct61t said:
We are a research centre, and responsible for product development for a private company. Our design work has come to the stage of product validation phase. Neither our research centre nor the private company has GMP ISO 13485 certification.

We are engaging a GLP lab to do all validation tests for us. But we need to prepare validation protocol before the test. I'm not sure whether the validation protocol issue by our research center are validate to be used in either CE or FDA certification.

We are really worry about this, could any experts here can help me?

Thanks a lot...

Can someone help with this?

Thank you!!

Stijloor.

Ronen E · Aug 8, 2011

ctct61t said:
We are a research centre, and responsible for product development for a private company. Our design work has come to the stage of product validation phase. Neither our research centre nor the private company has GMP ISO 13485 certification.

We are engaing a GLP lab to do all validation tests for us. But we need to prepare validation protocol before the test. I'm not sure whether the validation protocol issue by our research center are validate to be used in either CE or FDA certification.

We are really worry about this, could any experts here can help me?

Thanks a lot...

Hi there,

From neither a CE marking perspective nor a FDA one, it doesn't matter who prepares the validation protocol, as long as the protocol itself is adequate. Further, from the same perspective, the regulatory responsibility lies with the legal manufacturer (sounds like it's your client, the company you develop the device for), and although contractual obligations may render you legally responsible towards THEM (I can't say for sure because I didn't see the contract), you shouldn't be held regulatorily accountable because you don't place a device on the marketplace.

2 other concerns:

1. The entity placing the device on the market must have a compliant quality management system. For the FDA it must comply with the QSR (21 CFR part 820), and for the CE marking it would be highly recommended to comply with ISO 13485 (unless it's a class 1 device).

2. A typical robust validation would involve commercial production line units. If you're not sure about the protocol, and the testing is to be done by a 3rd (4th?) party lab, then where (and how) are the test units going to be made?

FYI, a good validation is typically a highly integrated and coordinated effort; it's not a very modular activity by nature. I think you're up for some trouble if you're going to break it up into pieces.

Cheers,
Ronen.

ctct61t · Aug 8, 2011

Ronen E said:
Hi there,

From neither a CE marking perspective nor a FDA one, it doesn't matter who prepares the validation protocol, as long as the protocol itself is adequate. Further, from the same perspective, the regulatory responsibility lies with the legal manufacturer (sounds like it's your client, the company you develop the device for), and although contractual obligations may render you legally responsible towards THEM (I can't say for sure because I didn't see the contract), you shouldn't be held regulatorily accountable because you don't place a device on the marketplace.

2 other concerns:

1. The entity placing the device on the market must have a compliant quality management system. For the FDA it must comply with the QSR (21 CFR part 820), and for the CE marking it would be highly recommended to comply with ISO 13485 (unless it's a class 1 device).

2. A typical robust validation would involve commercial production line units. If you're not sure about the protocol, and the testing is to be done by a 3rd (4th?) party lab, then where (and how) are the test units going to be made?

FYI, a good validation is typically a highly integrated and coordinated effort; it's not a very modular activity by nature. I think you're up for some trouble if you're going to break it up into pieces.

Cheers,
Ronen.

Hi Ronen,

Thank you very much for your valueble reply.

As a product development research center, we will prepare test protocol for product validation. I'm wondering without GMP system monitoring, how we make sure the protocols we prepared are adequate.

As per contract, our client the Device owner will take the responsibility for CE and FDA application. The product will be manufactured by a ISO13481 certificated contract manufacturer.

Hope to hear from experts again. Thanks...

Hi Stijloor, Thank you for your supporting.

Ronen E · Aug 8, 2011

ctct61t said:
Hi Ronen,

Thank you very much for your valueble reply.

As a product development research center, we will prepare test protocol for product validation. I'm wondering without GMP system monitoring, how we make sure the protocols we prepared are adequate.

As per contract, our client the Device owner will take the responsibility for CE and FDA application. The product will be manufactured by a ISO13481 certificated contract manufacturer.

Hope to hear from experts again. Thanks...

Hi Stijloor, Thank you for your supporting.

Hi,

The validation protocol will be adequate if it meets the applicable regulatory requirements (e.g. ISO 13485, 21 CFR part 820 etc.). You can make use of the many guidance documents available free online on process validation and validation in general. As a start, you could look in the FDA's and GHTF's websites. Also, you can scroll down (or use the search options) to find related threads, that may contain useful attachments, in the Elsmar Cove.

Re. ISO 13485 certified contract manufacturer (I assume it was a typo) - it doesn't relieve the device owner (your client) from the requirement to have their own compliant QMS, although its scope may be reduced. Further, I understand that this validation is going to involve at least 4 different entities (the device owner, the contract manufacturer, your company and the lab)... Hmmm... doesn't look too good... Though I'm not sure it's your company's concern. Definitely a concern for the device owner.

Have a lovely day,
Ronen.

ctct61t · Aug 10, 2011

Ronen, Thanks a lot...

We are preparing samples for animal trial and small population at this stage. We try to manufacture and test all samples under GMP or GLP environment. Hope all data are valid for FDA and CE registration.

Thanks ...

Ronen E · Aug 10, 2011

ctct61t said:
Ronen, Thanks a lot...

We are preparing samples for animal trial and small population at this stage. We try to manufacture and test all samples under GMP or GLP environment. Hope all data are valid for FDA and CE registration.

Thanks ...

OK, I thought you were working on process validation :bonk:

For pre-clinical and clinical trials compliance I strongly recommend you consult the abundant regulatory guidance concerning clinical trials, GCP etc. (as well as the regulation itself). Please also note that the requirements for FDA and the EC regulation are not identical.

Cheers,
Ronen.

Preparation for Product Validation Protocol

ctct61t

Stijloor

Ronen E

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ctct61t

Ronen E

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ctct61t

Ronen E

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