Purchasing Controls - Prerequisites for Batch Release or even before Purchase Order

[v9991]

following requirement translates to "evaluation of supplier" - specification - quality agreement - and 'type&controls"

my query is for following points.

a. how to interpret following .

...ensure that all purchased or otherwise received product and services conform to specified requirements...

option 1:- all the above mentioned relates are pre-requisites for purchase requisition.
option 2 :- all the above points to be in place before batch-initiation and batch-release.

Subpart E--Purchasing Controls
Sec. 820.50 Purchasing controls.

Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.
(a) Evaluation of suppliers, contractors, and consultants. Each manufacturer shall establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Each manufacturer shall:
(1) Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented.
(2) Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results.
(3) Establish and maintain records of acceptable suppliers, contractors, and consultants.
(b) Purchasing data. Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services. Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device. Purchasing data shall be approved in accordance with 820.40.

 

[QA-Man]

Re: Purchasing Controls - Prerequisites for Batch Release or even before Purchase Ord

I think it all means make sure what you received is what you wanted (more or less). It could be incoming inspection against documented specifications or it could be looking at a certificate of analysis.

I wouldn't focus on differentiating "purchased" or "otherwise received". I have seen raw materials and product received from another division within the same company that was treated like a purchase from an outside company.

 

[v9991]

Re: Purchasing Controls - Prerequisites for Batch Release or even before Purchase Ord

I think it all means make sure what you received is what you wanted (more or less). It could be incoming inspection against documented specifications or it could be looking at a certificate of analysis.

I wouldn't focus on differentiating "purchased" or "otherwise received". I have seen raw materials and product received from another division within the same company that was treated like a purchase from an outside company.

I agree.
However the question and options I tried to inquire is whether 'pre-requisites' of audit-Quality/Technical agreement etc to be established before validation batches; OR they have to be done before placing purchasing order.

 

[Sarah Stec]

Re: Purchasing Controls - Prerequisites for Batch Release or even before Purchase Ord

a. how to interpret following .

Personally, I interpret it to mean that regardless if you bought the item or it was given to you, you need to apply purchasing controls. In other words, the item should conform when you receive it, not afterwards.

IME, the quality/technical agreement usually comes before the purchasing order, not once the manufacturer has already received the product. I can imagine various situations in which the supplier wouldn't agree to guarantee a specific quality/technical specification for material the supplier no longer has.