Template for Vendor (Supplier) Qualification

C

chimie

#11
Re: Template for Vendor (Supplier) Qualification needed

Thank you but still looking for a simple procedure for the drug industry. Can I get away with a documentation audit and not have to visit the facility? Thanks!
 
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v9991

Trusted Information Resource
#12
Re: Template for Vendor (Supplier) Qualification needed

the minimum you could have is a documentation audit (self assessment questionnaire which outlines your interpretation of minimum GMP requirements...and once filled/completed, outlines the supplier's confirmation/commitment about fulfilling the pertinent requirements) this also helps you ensure that you verify/ensure certain standards are met...

this is then supplemented by technical/GMP agreement, which categorically signs-off the accountbilities of meeting respective activities...

above two procedural requirements, are supplemented/supported by the assessment of criticality of material to your product. (product/process assessment...)

here;s few quick references...
http :// apic. cefic. org/pub/guideline supplier qualification_dec09final .pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED

http :// www .tga.gov.au/pdf/manuf-twg-cm-supplier-qualification.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED

http://www.pharmtech.com/pharmtech/article/articleDetail.jsp?id=632990

http :// www .gmp-publishing.com/media/files/leseproben/Extract-18.H-Questionnaire-for-preparing-GMP-inspections.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED

http://www.who.int/3by5/en/who-edm-par-99-5.pdf

off late the VQ has been a key focus are in the regulatory audits...
 
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C

Chance

#13
Re: Template for Vendor (Supplier) Qualification needed

If the company fails to develop a supplier re-evaluation program then what is a true root cause that you can think of.
Perhaps you will dig deeper and find out why. We don't know what happened.
1. Is this requirement new to your orgnization? If yes, that is why there is no supplier qualificaiton, re-evaluation that exist. State that the organization is working on establishing it from now onwards.
2. If this is not a new requirement, we can't tell you why your organization failed to develop one. Perhaps, it was on the list but in the lower priority?
3. If this is not a new requirement, perhaps no one detected it before.
4. A weakness in the system but the organization is working on establishing it.:agree:
 
C

chimie

#14
Re: Template for Vendor (Supplier) Qualification needed

v991,
Could you please elaborate a little bit more on the last two requirements or if you have a sample, that would be great. Also, do suppliers that are ISO certified need to be qualified?
Thanks!
 

v9991

Trusted Information Resource
#15
Re: Template for Vendor (Supplier) Qualification needed

v991,
Could you please elaborate a little bit more on the last two requirements or if you have a sample, that would be great. Also, do suppliers that are ISO certified need to be qualified?
Thanks!
1) i guess you are asking about the product & process assessment...
*) (if required on multiple batches to show the consistency) assessment of an independent(inhouse qC) analysis and comparison of results against supplier provided COA
*) if material is critical, then usage of material in the product (a finished product ) and performance of the FP (both COA and if required stability)

2) sample template...can found online(even within elsmar) ...yet need to be customized to your specific defined procedure of your organization...

3) irrespective of accreditation or the even the regulatory audits, regulators expects you to operate within the purview of your own quality systems.... i.e., you must 'justify' the decision/procedure of not qualifying the suppliers with an accreditation. (or doing through alternative steps...viz., atleast postal audits, doing an assessment on complaints, regulatory observations etc)

hope that it helps...
 
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C

chimie

#16
Re: Template for Vendor (Supplier) Qualification needed

Thank you v9991. For a thorough documentation audit, I am requesting a survey to be filled out and the following items to be sent:
Certificate of ISO
QA manual
Industry references
Product samples with CofAs
What else am I missing for a thorough documentation audit? Thanks!


Also, in what instances would it be deemed necessary to do an on-site audit after completing a documentation audit?
 
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v9991

Trusted Information Resource
#17
Re: Template for Vendor (Supplier) Qualification needed

you can keep growing those general things..
apart from them, you questionnaire should actually allow user to confirm/commit the availability of suitable systems required to deliver a consistent product...(these can essentially evolve from your expectations of supplier's quality systems...)

just in case if you have not already seen these...
here's few quick references from net... http://www.gmpsop.com/forms/Form-385_Vendor_Audit_Questionnaire.pdf

http :// www. mageeplastics.com/airlines/pdf/QA-001%20Rev%20F%20Mail%20Audit.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED

http :// www .elbitsystems-us. com/sites/default/files/imported/corporate/suppliers/doc/CC-09-03%20Rev%20new%20-%20Supplier%20Quality%20System%20Audit%20Checklist%20_4_.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED

GMP Audit Checklist for GMP

also have a look at pg.1 of this very post....
hope this helps...
 
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C

chimie

#18
Re: Template for Vendor (Supplier) Qualification needed

v991,
Thank you. Would you happen to have the appendices that go along with this document? Thanks!
 
C

chimie

#19
Re: Template for Vendor (Supplier) Qualification needed

Found the appendices. For ongoing monitoring, if we plan to do a quarterly and an annual assessment where the annual includes a full assessment of supplier performance, what should be included in a quarterly assessment at the minimum? I am trying to distinguish between the two assessments and trying to make quarterly assessments as brief as possible. Thanks!
 
K

kgott

#20
Re: Template for Vendor (Supplier) Qualification needed

If I may, I would like to challenge your line of thought regarding the need for procedure(s). In accordance with ISO 13485:2003 clause 7.4.1 'the organization shall establish documented procedures to ensure that purchased product conforms to specified purchase requirements". Nowhere in the standard is there a requirement for a documented procedure for suppllier selection, so I am challenging the need for one within your organization.

The standard goes on to say "the organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be established." .
I agree and I will add that it does not need to be complicated either.

In a previous role the safety department would send out multiple pages of questionnaires to all suppliers on the basis that they were 'qualifying them.' I opposed it vigorously. I took the view that we fulfilled the requirements of 7.4.1 just by saying that suppliers were approved using any criteria management deemed suitable (including the requirements of 7.4.1) and that they remained approved until they were unapproved.

In other words, until management decided to discontinue using a particular supplier, all suppliers remained approved and could continue to supply the company.

While we maintained a list of suppliers and their contacts and the services they provided, it was for ease of reference only.
 
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