SOP for Qualification of Vendors : Pharmaceutical Guidelines

SOP for Qualification of Vendors

Standard operating procedure to qualify the vendors for raw materials and packing materials.


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

2.0 SCOPE:

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


QA Officer / QA Executive


Head- QA & QC


5.1 Procedure for inclusion of vendor in approved vendor list (Raw materials)

5.1.1 New vendors shall be qualified and approved by QA department before regular supply of raw materials.
5.1.2 Purchase department shall locate the new vendor and find out the details of products manufactured supplied by them. In case of existing materials, Purchase department shall provide specification to the vendor.
5.1.3 In case of RM source, after the initial assessment, Purchase department shall arrange to get the Supplier Questionnaire filled by the supplier.
5.1.4 If the Questionnaire evaluation is found suitable, Purchase department after discussion with R&D and QA shall ask for 3 batches of samples along with certificate of analysis of in-house & Public Testing Laboratory for quality evaluation and subsequent stability studies.
5.1.5 Purchase department shall arrange to send 3 batches of samples along with New Source Request form to R&D for quality evaluation and stability testing.
5.1.6 R&D shall send the samples along with New Source Request Form to QA Head for evaluation

5.2 New Source Request Form

There are three types of new sources.
  • New material from a new source.
  • Existing material from a new source
  • New material from an existing approved source.

5.3 Evaluation of a New Source

5.3.1 QC shall analyse the samples sent by R&D as per approved specifications and testing procedures.
5.3.2 If the samples are found to be in compliance with the specifications, QA shall send the analytical report to R&D along with the New Source Request Form.
5.3.3 R&D, in consultation with QA shall decide the criticality and necessity of carrying out usage test and stability studies. The necessity of carrying out machine trials shall also be evaluated by R&D, in consultation with QA / Production.
5.3.4 R&D, shall carry out the usage test and machine trials, if required. R&D, will also recommend the need to do stability studies, if required, and communicate the same with other recommendations to Head QA.
5.3.5 Following the evaluation carried out depending on the criticality of the material, the Head QA shall recommend an audit of the Supplier’s premises.

5.4 Approval of New Source

5.4.1 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 function.
5.4.2 In case when the new material is from an already approved source, the approval may be recommended based on the pre-approval Questionnaire evaluation after completing New Source Request form.
5.4.3 If the supplier’s facilities and operations meet requirements as documented in the audit report then the respective Head QA shall approve the supplier.
5.4.4 The auditor must arrange to send the signed copy of audit report to the audited supplier.
5.4.5 After approval, Head QA, where the material is used, 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.
5.4.6 Purchase department shall carefully study the quality aspect and also the quantity and financial aspects of the vendor, they are as follows:
a) Capability of the vendor to supply the required material within the period.
b) Delivery schedule in order not to affect the production cycle.
5.4.7 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.
5.4.8 On ensuring compliance with specifications the vendor shall be included in approved vendor’s list.
5.4.9 All the suppliers of RM evaluated by R&D dept. On the basis of process / product development parameters shall be considered as temporary vendors and based on the commercial production supply, they shall be transferred to approve vendor list and shall be considered as approved vendors.
5.4.10 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.
5.4.11 The Vendor shall reply to the audit report with the action plan on CAPA along with the expected date of completion of CAPA items.
5.4.12 The quality function shall follow up for with the supplier on the implementation and compliance of the CAPA items suggested in the CAPA plan.

5.5 Procedure for Inclusion of Vendor in Approved Vendor List (Packaging Materials)

5.5.1 New vendors must be qualified and approved by QA department before regular supply of packaging materials.
5.5.2 Purchase department shall locate the new vendor and find out the details of products manufactured / supplied by them. In case of existing materials, Purchase department shall provide specification to the new vendor.
5.5.3 For printed and primary packaging materials, vendor audit is performed by representative of QA department and GMP Cell.
5.5.4 Samples of printed packaging materials if necessary shall be submitted to QA department.
5.5.5 Purchase department after studying the comments of QA department shall inform the supplier for the supply of the material.
5.5.6 Based on the product compliance and assessment, further procurement of packaging material should be continued. On ensuring compliance with specifications the vendor shall be included in Approved vendor’s list.

5.6 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 :
a) 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.
b) 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.
c) 3 out of 10 lots fail to comply the specification in a specified period under review.
d) The delivery schedule is not met for 40% supplies.
e) The rates mentioned in Purchase Order, differs than the rates mentioned in delivery challan and invoice.
5.6.1 The aspects like the capability of supplier to provide regulatory support, meet the official requirement shall be evaluated during supplier audit.
5.6.2 The commitment to notify changes to company prior to implementation e.g change in mfg site, change in process shall be taken.
5.6.3 The commitment to investigate failure promptly in case of any failure reported shall be assured by the supplier and the capability of supplier shall be evaluated on this front.

5.7 Corrective and Preventive Action

5.7.1 The vendor, who has been excluded from the approved vendor’s list as well as those which are disqualified and seek inclusion, may be included by only after CAPA verification of previous items on their satisfactory closure and effective implementation of CAPA.
5.7.2 The vendor shall be made aware of the reasons for his exclusion and shall be asked for explanation.
5.7.3 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.
5.7.4 Carry out the discussion on other non-quality issues like delivery schedule and rate, etc.
5.7.5 After satisfactory compliance of all above points and ensuring the completion of CAPA plan, the vendor shall be considered as approved vendor.
5.7.6 The CAPA compliance of previous audit shall be verified in the subsequent audit.
5.7.7 The CAPA verification documents, if any shall be kept along with the audit and compliance report.


List of approved vendors to be prepared once in a two years or as & when required.


6.1 SOP: Standard Operating Procedure
6.2 QA : Quality Assurance
6.3 QC : Quality Control
6.4 RM: Raw Material
6.5 R&D: Research and Development
6.6 CAPA: Corrective Action and Preventive Action
6.7 GMP: Good Manufacturing Practice
6.8 Mfg: Manufacturing

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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