SOP Number:QA-013

Title: Standard Operating Procedure for New Vendor Selection

1.Purpose
 To provide methods for determining, documenting and, when applicable, inspecting vendors for
compliance with our company policies and contract purchasing requirements.
 Selection of appropriate suppliers that have the capability and systems to supply products to satisfy our
requirements.
2.Scope
This procedure applies to all vendors of materials that directly affect the Quality of the company’s products and
services.

3.Validity
This SOP is valid up to the next revision date and only if it bears the control seal.

4.Responsibility
 Procurement & Supply Department is responsible for initial supplier identification and for collection of
business information related to the potential supplier
 Finance Department is responsible for evaluation of the potential supplier’s financial information
 Quality Assurance is responsible for evaluating the supplier’s or manufacturer’s Quality systems as
appropriate and for reporting supplier Quality performance on a continuous basis
 Purchase Committee proposal to make manufacturers or suppliers audit.
5.Materials and Equipment
Nil
6. Procedure
6.1 New and short listed vendors are to be evaluated using the following criteria
 Pricing: competitive pricing is one component of the evaluation and may be outweighed by
other factors. Pricing alone will not be a deciding factor unless all else is equal.
 Availability and shipping/delivery time frame.
 Performance capability( i.e., financial status, sufficient facilities )
 Internal Quality Assurance system: companies certified to GMP and ISO: 9001 are given
preference.
 Sample testing to check whether it fulfills EPHARM’s specification.
 New suppliers should be requested to provide information that might differentiate them from
other vendors/suppliers in market place.
 If the supplier is not manufacturing the items, they are obliged to disclose the manufacturer to
EPHARM ( its Quality system, site /address)
6.2 Ongoing evaluation of suppliers:

 On time Delivery ,100% on time expected ( 0 days early, 0 days late)

6.3 Qualified vendors will be maintained on approved supplier list for procurement.
6.4 Completing New Vendor Notification form for approval of all first time purchases from vendor.
6.5 Disqualification: suppliers not responsive to corrective action requests or unable to correct problems with
delivery or quality may be disqualified. Disqualification is generally a consensus decision between the Quality
Assurance Manager and Purchasing Committee.
6.6 Vendor Inspections
 For critical components or for inventory purchases that our Company desires to rely on the Quality
Assurance of the vendor to reduce receiving inspection or testing requirements, an on sight vendor
inspection must be performed and approved.
 The Quality Assurance Manager with consultation of Purchase Committee will co-ordinate, arrange
and designate staff for all vendor inspections.
6.7. New supplier shall submit COA of three test samples, stability data, method of analysis (if not compendial)
and material safety data sheet. Then up on evaluation of the test samples and documents, vendor file will be
prepared and maintained for all vendors and included in the Approved Vendor List.

7. Reporting
 New vendor notification form
 Vendor survey form
 Supplier selection criteria
8. Reference Documents: Nil