Poor control of testing chemicals ? which ISO 13485/9001 clause does it contravene?

N

nring

#1
Poor control of testing chemicals – which ISO 13485/9001 clause does it contravene?

I just started at a company that is ISO 13485/9001 certified but has only been so for 2 years. Some areas make medical devices, some do not and some work with both. We've had problems with departments conforming to the standards, especially the 9001. We have one area that performs chemical testing-I would say it's analogous to inspections testing-on both types of products. During an internal audit they were issued none conformances for the chemicals they use in testing the product not being marked with acceptance stickers, really have no specs, and are used at times when they are expired. Their argument is that because it's raw materials that are not used in production of the product then it doesn't apply. I've been asked to show where it states that in the standard. I've argued that it falls under 7.6 Control of Monitoring and Measuring Devices to no avail. Can I get some opinions on who is interpreting the standard correctly?

Thanks in advance! :frust:
 
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Scott Catron

True Artisan
Super Moderator
#2
Re: Poor control of testing chemicals – which ISO 13485/9001 clause does it contraven

(I moved this thread to the medical device forum.)

I'm not familiar with ISO 13485, but the FDA would take a dim view of this practice also:

21 CFR Sec. 820.80

(d) Final acceptance activities. Each
manufacturer shall establish and maintain
procedures for finished device acceptance
to ensure that each production
run, lot, or batch of finished devices
meets acceptance criteria.

If your reagents are past expiration or not even standardized, there's no way to ensure the production lot meets any criteria.
 
M

mlabardi

#3
Re: Poor control of testing chemicals – which ISO 13485/9001 clause does it contraven

I don't know if I can be of any help- but I will try.

Yes there should be "defined" procedures and specifications for raw materials used in testing that are not used in production. However, this can be a double edged sword (if you need a chemical to test a chemical). You don't want to play the chicken and the egg game.

In my experience I have always had specific procedures that defined the grades required, a procedure for obtaining, maintaining, and archival or all certificates of analysis received from the manufacturers. No physical/chemical testing was actually performed on stock raw materials used for testing. If an in-house solution was prepared for testing it would be standardized (for volumetric solutions) before it could be used- and they would have to periodically re-standardized. The length of time depended on the solution stability.

All testing raw materials should be labeled to indicate their status and prevent mixups. They were never labeled as "approved" or "accepted" since they had to be quickly distinguished from the manufacturing chemicals. They had a separate procedure for labeling.

The testing procedures described in detail exactly which reagent should be used for testing (including the grade).

They should be following expiration dates on the chemicals. Depending on the stability of the chemical a shorter expiration date (earlier than the manufacturer) may need to be assigned after opening the container. We had to periodically assign someone to go through all reagents once a month to make sure there were no expired reagents that could accidentally get used.:)
 
F

freelovefest

#4
Re: Poor control of testing chemicals – which ISO 13485/9001 clause does it contraven

I think there is no doubt these need to be controlled. If you would like a little more guidance or something to show to people you can look at ISO14969. The section after 7.6 details what the requirements might be. Below is a paraphrased excerpt

"The requirements of this subclause are also applied by the organization when demonstrating the conformity of product to the specified requirements. This can involve measurements subsequent to production and inspection of product (e.g. during handling, storage, packaging, preservation, delivery or servicing). Documented procedures should include details of equipment type, unique identification, location, frequency of checks, check method and acceptance criteria."

This tells what the intent of the requirements application is. This would certainly apply to chemicals used, even more so if they are being used to calibrate other equipment. Hope this helps out.
 
#5
Re: Poor control of testing chemicals – which ISO 13485/9001 clause does it contraven

The feedback provided is correct.

I love that they want to see the regulation that tells them they have to test components used for releasing the product. Is a few regulatory guideliens holding up moving forward this process or is this just a delay/blow-off tactic that worked for them with the previous QA person?

Because if it is the first, look at the big picture and point to the costs of selling bad product versus the cost of having assurance of what you are doing.

If it's the later - escalate it up to higher management - for they are the ones who has speak to the product's quality based on the release criteria in which you have incomplete raw material incoming and release specifications.

Sorry - I dont mean to add to the fire but if the only response you get is that there isnt any regulation that tells us we have to versus a logical justification is just people being lame in my opinion.
 
D

DsqrdDGD909

#6
Re: Poor control of testing chemicals – which ISO 13485/9001 clause does it contraven

FDA's reg.:
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.83]

[Page 315]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES

PART 58--GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES--Table of Contents

Subpart E--Testing Facilities Operation

Sec. 58.83 Reagents and solutions.

All reagents and solutions in the laboratory areas shall be labeled
to indicate identity, titer or concentration, storage requirements, and
expiration date. Deteriorated or outdated reagents and solutions shall
not be used.



This link may help:
http://www.contractpharma.com/articles/2007/05/quality-assurance-and-good-lab-practice

Excerpt:
Test and Control Articles (Items) Characterization, Handling and Mixtures – FDA = §58.105, 58.107, 58.113; OECD = §6.1, 6.2


One of the key and important differences is that FDA does not include a requirement for reference articles (i.e., analytical standards). OECD's definition of reference item can include both control items and reference items.
FDA states that a storage container shall be labeled with name, chemical abstract number or code number, batch number, expiration date, if any, and storage condition if appropriate. OECD does not require batch number.
For control article characterization, FDA states, "in those cases where marketed products are used as control articles, such products will be characterized by their labeling. OECD does not include this statement.
For stability of test and control articles, as such or in mixtures, FDA states that this can be determined before study initiation or concomitantly according to SOPs. OECD states only that stability of the test item in the vehicle should be determined.
FDA states that if more than one component of a mixture has an expiration date, the earliest date shall be shown on the container. OECD does not address this, but it would be the expectation.

As noted in item 1 above, the most significant difference is that FDA does not address reference standards, to which all characterization, stability, receipt, distribution and disposal requirements apply under the OECD GLP, not counting the requirements to their mixture with a carrier.
 
Last edited by a moderator:

harry

Super Moderator
#7
Re: Poor control of testing chemicals – which ISO 13485/9001 clause does it contraven

........ During an internal audit they were issued none conformances for the chemicals they use in testing the product not being marked with acceptance stickers, really have no specs, and are used at times when they are expired. Their argument is that because it's raw materials that are not used in production of the product then it doesn't apply. I've been asked to show where it states that in the standard. I've argued that it falls under 7.6 Control of Monitoring and Measuring Devices to no avail. Can I get some opinions on who is interpreting the standard correctly?

Thanks in advance! :frust:
We have to go back to the much debated old subject of Internal Audit and ask ourselves what is the purpose of an internal audit?

Is it just to ensure that we pass the third party audit or to discover weaknesses in our system and hopefully improved from there? For business reasons, the later should be the aim. Therefore, internal audits can point out any thing not working as common sense tell us that it should. In this case, common sense tells me that some good practices are not being observed and the best person to rectify it should be the relevant departmental head.
 
M

mlabardi

#8
Re: Poor control of testing chemicals – which ISO 13485/9001 clause does it contraven

We have to go back to the much debated old subject of Internal Audit and ask ourselves what is the purpose of an internal audit?
:agree1:
Internal audits help identify weakness in the systems not just the regs. I have alsways used internal audits as ways to identify improvement and maybe find noncompliance. It sounds like there is a department there that does not respect QA (I am sure that we have all come across those departments).;)
 
M

meimei

#9
Re: Poor control of testing chemicals ? which ISO 13485/9001 clause does it contraven

FDA's reg.:
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.83]

[Page 315]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES

PART 58--GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES--Table of Contents

Subpart E--Testing Facilities Operation

Sec. 58.83 Reagents and solutions.

All reagents and solutions in the laboratory areas shall be labeled
to indicate identity, titer or concentration, storage requirements, and
expiration date. Deteriorated or outdated reagents and solutions shall
not be used.



This link may help:
http://www.contractpharma.com/articles/2007/05/quality-assurance-and-good-lab-practice

Excerpt:
Test and Control Articles (Items) Characterization, Handling and Mixtures – FDA = ?58.105, 58.107, 58.113; OECD = ?6.1, 6.2


One of the key and important differences is that FDA does not include a requirement for reference articles (i.e., analytical standards). OECD's definition of reference item can include both control items and reference items.
FDA states that a storage container shall be labeled with name, chemical abstract number or code number, batch number, expiration date, if any, and storage condition if appropriate. OECD does not require batch number.
For control article characterization, FDA states, "in those cases where marketed products are used as control articles, such products will be characterized by their labeling. OECD does not include this statement.
For stability of test and control articles, as such or in mixtures, FDA states that this can be determined before study initiation or concomitantly according to SOPs. OECD states only that stability of the test item in the vehicle should be determined.
FDA states that if more than one component of a mixture has an expiration date, the earliest date shall be shown on the container. OECD does not address this, but it would be the expectation.

As noted in item 1 above, the most significant difference is that FDA does not address reference standards, to which all characterization, stability, receipt, distribution and disposal requirements apply under the OECD GLP, not counting the requirements to their mixture with a carrier.
Hi,

Need some help on this.

Our chemical supplier do not provide the expiry date but released date. The chemical is to be used for our R&D testing and manufacturing. Is there a must to be expiry date indicated or identified under ISO 13845 standard?

Thanks in advance
 
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