SOP for Vendor Management and Qualification

OBJECTIVE

To provide criteria in choosing suppliers for active materials and to ensure that starting materials are only purchased from approved suppliers. 

SCOPE

The guidelines refer to the process of approving suppliers of active raw materials for the production of products at PharmaInfo Limited.

RESPONSIBILITY

• The Supply Chain and Logistics department shall be responsible for sourcing of materials from suppliers and providing them with the correct specifications. 
• The Q.A. department shall provide the Supply Chain and Logistics department with specifications, sample and test the materials, and either approve or reject them based on the results found.

• The warehouse department shall be responsible for the receipt and proper storage of the materials. 
• The production department shall conduct trial batches and commercial batches. 

ALSO READ: Vendor Development in Pharmaceuticals

PROCEDURE

• Based on the need for a new supplier the Supply Chain and Logistics Manager shall identify potential suppliers with the following considerations.

1. Ability to supply quantity and quality as specified on the purchase order. 
2. Reputation and reliability of suppliers, based on previous dealings and referrals from contacts in the pharmaceutical industry. 
3. Cost of materials. 
4. Delivery period. 
   

• Suppliers should identify manufacturers that are approved by regulatory authorities in the country of origin and should provide a cGMP certificate.

• The supplier shall supply samples for analysis (enough for at least two pharmacopoeial analyses), a certificate of analysis, and a route of synthesis in DMF. The supplier should also indicate the type of packaging of the material at delivery of the consignment. 
• Q.A. has to carry out physical and chemical analyses of the samples and compare them with the currently approved manufacturer. 
• Once satisfied the Q.A Manager shall give a go-ahead to the Materials Manager. 
• Materials for at least one batch shall be ordered. 
• The first batch produced shall be manufactured using the validated process, all pharmacopeia tests were done where applicable single point comparative dissolution with material from an approved supplier. 
• Conduct accelerated and ongoing stability on the batch to ascertain its stability. 
• Number of Lots: 

1. At least three consecutive receipts of each material bearing different lot numbers should be used for the approval process. 
2. No changes should be made by the suppliers to the manufacturing method or synthesis of the raw material. Any changes shall be communicated.

• Acceptance Criteria: 

1. The raw material from each supplier should consistently meet the specifications. 
2. Documented evidence that all laboratory equipment and apparatus are calibrated as per schedule. 
3. Batches in which the materials are used should consistently meet specifications. A review of historical data may be necessary.

ABBREVIATIONS

QA – Quality Assurance 

DMF – Drug Master File 

ANNEXURE

Nil

REVISION HISTORY

Nil

ALSO READ: SOP for Vendor Qualification and Approval