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SOP for Vendor Qualification and Management

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 production of products at XYZ 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, 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. 
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PROCEDURE:
  • Based on the need for a new supplier the Supply Chain and Logistics Manager shall identify potential suppliers with the following considerations.
a) Ability to supply quantity and quality as specified on purchase order. 
b) Reputation and reliability of suppliers, based on previous dealings and referrals from contacts in the pharmaceutical industry. 
c) Cost of materials. 
d) Delivery period.  
  • Supplier should identify manufacturers that are approved with 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 analysis), certificate of analysis and route of synthesis in DMF. The supplier should also indicate type of packaging of the material at delivery of consignment. 
  • Q.A has to carry out physical and chemical analysis of the samples and comparing with current 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 pharmacopoeia tests done where applicable single point comparative dissolution with material from approved supplier. 
  • Conduct accelerated and on-going 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 

REVISION HISTORY:
Nil

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