Vendor Qualification

1.0 OBJECTIVE

To lay down a procedure for identification, development and qualification of vendors for Raw and Packaging Materials.

2.0 SCOPE

This procedure is applicable to all the drug products manufactured at Indian XXX, Place

3.0 RESPONSIBILITY

3.1 Coordination: Head-Quality Assurance

3.2 Vendor Development: Purchase department

3.3 Analysis : Head- Quality Control

4.0 PROCEDURE

4.1 Identification of the good vendor is critical for the manufacturing process and its quality.

4.2 Vendor Qualifications shall be done as given below

4.2.1 FOR EXISTING VENDOR

4.2.1.1 Active, Raw materials and Packing materials are used for the Production of Tablets, Powders and Liquids are sourced from Unit-I.

4.2.2 FOR NEW VENDOR

4.2.2.1 VENDOR IDENTIFICATION

4.2.2.2 The requirement of new Raw & packing materials and their profiles shall be given by the Marketing department based on customer orders they receive, new product launch etc.

4.2.2.3Marketing department shall forward the requirement of raw and packing material details to Quality Assurance department to check the feasibility.

4.2.2.4 Head-Production shall review the details of the materials in co-ordination with Quality control, quality assurance and prepare a tentative/approved specifications based on the expertise and trials case by case.

4.2.2.5 Head – Purchase shall identify the vendors with the available information and specifications provided as above.

4.2.3 VENDOR DEVELOPMENT AND QUALIFICATION

4.2.3.1 The Vendor Questionnaire shall be sent to the identified suppliers along with the specifications of the material(s) as given in Annexure-1.

4.2.3.2 If the Questionnaire is found satisfactory, Head-Purchase shall request for pre purchase samples (three) along with Certificate of Analysis in case of raw materials, some sample packs in case of packing materials along with the primary packing material as applicable and same shall be forwarded to Head-QC/ Production for analysis and trials notifying through QA.

4.2.3.3 The Quality Control Department shall analyse samples as per the specifications and the Vendor Qualification Co-ordinator shall communicate the results with any other trials taken by the Production department to Head-Purchase and Formulation development department through QA.

4.2.3.4 Based on the initial assessment and results obtained from the samples the vendor shall be accepted or rejected.

4.2.3.5 Vendor Qualification co-ordinator shall draw an audit schedule for the accepted vendor(s).

4.3 In Charge Quality Assurance carry out an Audit. As per the Audit checklist (Annexure-2) to assess the Quality systems and the infrastructure of the vendor.

4.4 Based on the observations from the Audit checklist the vendor shall be approved or rejected. The Approved Vendors shall then be entered in the Approved vendor list (Annexure-).

4.5 If vendor audit is not performed, vendor survey is acceptable provided first three consecutive consignments for the commercial batches should be acceptable as per the specification. Then the vendor is said to be qualified including in the vendor list.

4.6 Vendor survey is based on the history of vendor like supply of material to various approved organizations, year of manufacturing, and approval from regulatory bodies like USDMF/EDMF etc.,

4.7 If any adverse observations are found during the period of stability studies Head-QC shall immediately bring the same to the notice of Head–Production and Head-Quality Assurance.

4.8 After investigation the reason for adverse result is found to be due to the material received from the approved vendor, and then the vendor shall be disqualified and deleted from the Approved vendors list.

4.9 Head-QA shall carry out the investigation as per the Failure Investigation SOP.

4.10 QA shall take the following actions. Explore the necessity of recalling the batches from the market in accordance with the “Product Recall” SOP and if found necessary, recall the batches.

4.11 The addition of new vendors shall follow the above procedure by the Head –Purchase.

4.12 The change in the Approved vendor shall follow the change control procedure.

4.13 Head-Purchase shall initiate the change control for the acceptance of the vendor in accordance with the SOP of change control.

4.14 The disqualification of the approved vendor shall also be based on the following, but not limited to;

4.14.1 Re audits of the vendors

4.14.2 Market complaints

4.14.3 Delivery schedule

4.14.4 Quality and Quantity of dispatch

4.14.5 Natural Disasters

4.15 Audit Frequency

4.15.1 Approved vendors shall be audited at least once in two years on a regular basis

4.15.2 In case if any Market complaints or changes in existing processes the vendor shall be re audited.