Sample Retention - Quantity, Retention Period, Storage

Ajit Basrur

Staff member
Admin
#1
Hi,

What is the general practise for "Retain Samples" with respect to quantity, retnetion period, storage practise etc ?

Thanks,
Qualityalways
 
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Ajit Basrur

Staff member
Admin
#3
Hi,

If there is no customer requirement, how much would be the retention period ? Is there any requirement like in Pharma, to keep for Expiry period + 2 years and so on ?

Thanks,
Qualityalways
 
D

Duke Okes

#4
Qualityalways said:
If there is no customer requirement, how much would be the retention period ? Is there any requirement like in Pharma, to keep for Expiry period + 2 years and so on ?
That depends on what industry you're in and who regulates that industry. If there are 'standard' requirements such as in Pharma, they would be specified in the standards (e.g., GMPs, ISO 13485, other regulatory documents). You might contact someone in the same industry you're in and inquire about record retention requirements. Perhaps search Elsmar or Google.
 

Al Rosen

Staff member
Super Moderator
#5
Since we're in the Medical Device Forum, I will take a big chance here and assume medical devices. I will also assume that retaining a sample is the same as retaining a record. The requirement for record retention is at least the lifetime of the medical device but not less than 2 years or as specified by regulatory requirements.
 
L

Linda W

#6
Al is correct...unless you sell to Europe as well as US. According to the Medical Device Directive Annex II 6.1, all quality records shall be kept minimum 5 years from the date when the last product was manufactured. According to CFR Part 820 all records apart from, management review, supplier audits/evaluations and internal audits shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.
 

Statistical Steven

Statistician
Staff member
Super Moderator
#7
Mr

Qualityalways said:
Hi,

What is the general practise for "Retain Samples" with respect to quantity, retnetion period, storage practise etc ?

Thanks,
Qualityalways
Sample retention is a little different than record retention. It is based on the expiry date of the product. The retention time cannot be less than your expiry date for the lot being retained. Usually you have a company policy that states how many lots per year will be retained. On the question of storage condition, the storage conditions are the same storage conditions required for the device (unless you are doing stability testing). The quantity is a risk based strategy, but usually you retain a sufficien quantity to retest per established QC methods. For example, if your QC method requires you do tensile strength on 10 units, then you would retain a quantity in multiples of 10.

Does that make sense?
 
G

Gilberto - 2009

#8
Depends your products manufacturing ...

Bulck Material have 3 according possible ...

and others Products (ex. Parts) according to application products...
 

Wes Bucey

Quite Involved in Discussions
#9
In my high tech contract machining business, I normally added a clause to each contract (since we were making custom products to a customer's design):
[we] will forward the exact First Article sample together with a list of the instruments used to measure each parameter together with the measurements so recorded so customer may independently check dimensions replicating the instrumentation used. [we] will send test samples of final inspection together with the inspection sheets listing the instruments and dimensions checked with the results for customer to confirm, hold, and maintain.

[we] will maintain test coupons of each lot of material together with physical and chemical properties analysis in a permanent file for any future reference which may be required.


We gave the product samples to the customer, since it was his design. We retained the material "coupons" [a six to ten inch bar of the material] together with a laboratory analysis of a similar coupon cut from the same bar from a specific lot of material because we often would use the same material for multiple customers since we specialized in making aerospace and medical device components from some "exotic" materials like titanium or specialty stainless steel alloys.

We were silent on "in-process" inspection because the dimensions and other characteristics during in-process were often merely internal to our Control Plan and had no relationship to final characteristics of finished product.
 
Last edited:
B

baynoli

#10
Hi,

Another follow-up question on the retention period. Most of my records are e-file
and this is contantly updated. What is my retention period for this type of records? Hope someone can advise. thanks.
 
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