SOP For vendor qualification is described in this post which you can follow in the section of the Quality Assurance Department.

OBJECTIVE:

To lay down the procedure for the qualification of vendors for the Raw materials and Packaging materials.

SCOPE:  

This SOP shall be applicable for all the incoming Raw materials and Packaging materials used for Own & Contract manufacturing sites.

RESPONSIBILITY: 

QA Officer.

ACCOUNTABILITY:

Quality Assurance Manager

PROCEDURE

New vendors shall be qualified before regular supply of raw materials. 

Purchase department shall locate the new vendor and find out the details of products manufactured supplied by them. 

In case of existing materials, provide specification to the vendor. 

After the initial assessment Supplier evaluation form shall be filled by the supplier and if found suitable, purchase department shall ask for 3 batches of samples along with certificate of analysis of in-house for quality evaluation and subsequent stability studies. 

Purchase department shall arrange to send 3 batches of samples along with request for vendor sample analysis for quality evaluation and stability testing. 

Vendor Sample Evaluation Request Form: 

There are three reasons for vendor sample evaluation; 

New material from a new source. 

Existing material from a new source 

New material from an existing approved source. 

Approval of Vendor  

The facilities and operations of the supplier’s manufacturing site must be subjected to a quality audit before the materials are used. 

Audit shall be conducted by the respective Quality Operations Department. 

In case when the new material is from an already approved source, the approval may be recommended based on the pre-approval vendor evaluation form

If the supplier’s facilities and operations meet requirements as documented in the audit report, then the vendor shall be approved

After approval, Head QA, shall give clearance for procurement of procuring a limited quantity of material for use in 3 production batches and evaluate these three batches critically for quality. 

Purchase department shall find out the rates quoted by the vendor whether they are competitive with respect to other vendors without compromising the quality aspects.  

On ensuring compliance with specifications the vendor shall be included in approved vendor’s list. 

After vendor audit, a vendor audit report classifying the observations as critical, major and minor with recommended corrective and preventive actions (CAPA) shall be issued to the vendor within 20 days for audit. 

The Vendor shall reply to the audit report with the action plan on CAPA along with the expected date of completion of CAPA items. 

The quality function shall follow up the supplier on the implementation and compliance of the CAPA items suggested in the CAPA plan. 

Procedure for Exclusion of Vendor from Approved Vendor List 

The vendor shall be disqualified and removed from the approved vendor’s list for the following reasons:

If a lot does not comply to the specification with respect to critical tests, then the vendor shall be disqualified. 

The vendor shall be qualified again on further evaluation and investigation. 

If a lot does not comply to the specification with respect to minor tests, then the vendor shall be disqualified if it is observed for 3 consecutive lots. 

3 out of 10 lots fail to comply the specification in a specified period under review. 

The delivery schedule is not met for 40% supplies. 

The rates mentioned in Purchase Order, differs than the rates mentioned in delivery challan and invoice. 

The aspects like the capability of supplier to provide regulatory support, meet the official requirement shall be evaluated during supplier audit. 

The commitment to notify changes to company prior to implementation (change in manufacturing site and change in process) shall be taken. 

The commitment to investigate failure promptly in case of any failure reported shall be assured by the supplier

Corrective and Preventive Action (CAPA)

The disqualified vendor may be included only after effective implementation of CAPA. 

The vendor shall be made aware of the reasons for his exclusion and shall be asked for explanation. 

Head Purchase, Head QA&QC and GMP Cell shall conduct facility audit of the vendor in order to ensure that quality system exists in the organization. 

Carry out the discussion on other non-quality issues like delivery schedule and rate, etc. 

After satisfactory compliance of all above points and ensuring the completion of CAPA plan, the vendor shall be considered as approved vendor. 

The CAPA compliance of previous audit shall be verified in the subsequent audit. 

The CAPA verification documents, if any shall be kept along with the audit and compliance report.