Vendor certification

After successful vendor auditing, it can be determined whether purchased ingredients and materials can be accepted on the basis of suppliers certificates, with minimized inspections of incoming goods to a certain level. Vendor certification leads to reduction of costs and release times. 

The vendor certification procedure may include a list of selected vendors, historical review of test results of previous suppliers, and formal inspection on site and decision making. 

Quality Audit. Quality audit is only one aspect of the due diligence process overall quality is the primary qualifier. Suppliers must be able to deliver quality products. They can demonstrate quality through ISO certification, CGMP compliance, and FDA inspection history, as well as their commitment to quality systems and vendor certification processes. 

Valves not UV stamped, but which are identical with designs which have been previously certified and marked per ASME Code Section VIII, shall be considered acceptable without further qualifying tests. Vendors certification to this effect shall be furnished. 

The current GMP requirement that materials must be tested or examined for all specifications and released prior to use is in conflict with the philosophy of vendor certification, which is based on a consistent, reliable record of good quality. Only vendors with well-controlled processes and a good record of acceptable batches qualify for such a program. Thus, a material could be put into use based on the quality record of the supplier (vendor), even if testing is only for identification [211.84(d)].[ l... 

A raw material vendor certification program, if employed, is documented in a standard operating procedure. There are several acceptable approaches to vendor certification. Such a program may include, the following auditing criteria ... 

The vendor certification program includes a procedure outlining how failures and any subsequent re-qualification are to be addressed and an indication of the types of lots not subject to the reduced testing program (e.g., reprocessed lots.)... 

Where a vendor certification program is implemented for a raw material, complete confirmatory testing is conducted with an appropriate frequency, but is not less than one lot or batch per year. 

The wrong solvent is introduced into the system instead of Freon 1137 Contamination undesired reaction Equipment damage pr uct loss waste disposal issues production downtime Vendor Certificate of Acceptance sampling/testing before off-loading Develop verification procedures prior to acceptance of product None... 

A vendor certificate with certified population N and D values is available. 

Source the task of material acquisition, set within an overall sourcing system that includes activities such as vendor certification and vendor contracting. 

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