Spplier Qualification is more than auditing. Supplier qualification can be seen as a risk assessment tool. It should provide an appropriate level of confidence that suppliers, vendors and contractors are able to supply consistent quality of materials, components and services in compliance with regulatory requirements.


An integrated supplier qualification process should also identify and mitigate the associated risks of materials, components and services. 


There are different directives and regulations for medicinal drug products. Certain requirements in different directives and the EU-GMP Guidelines define expectations. 


Here are some examples:

Article 8 of EU-Directive 2001/83/EC

"The application [of a marketing authorization] shall be accompanied […] by […] a written confirmation that the manufacturer of the medicinal product has verified compliance of the manufacturer of active substance with principles and guidelines of GMP by conducting audits."


Article 46b of EU-Directive 2001/83/EC

"Active substances shall only be imported if they have been manufactured in accordance with standards of good manufacturing practice at least equivalent to those laid down by the European Union". 


EU-GMP Guidelines Chapter 5 (Production):

5.27 "The selection, qualification, approval and maintenance of suppliers of starting materials, together with their purchase and acceptance, should be documented as part of the pharmaceutical quality system..."


5.29 "Audits should be carried out at the manufacturers and distributors of active substances to confirm that they comply with the relevant good manufacturing practice and good distribution practice requirements. (…) 


Chapter 7 of the EU-GMP Guidelines 

Outsourced Activities describes the responsibilities of the Contract Giver when it comes to contract manufacturing and testing. 


The qualified person of the marketing authorisation holder is responsible for certifying the drug product for the market place and is now being held accountable to ensure that all aspects of the supply chain have been made under the appropriate GMPs. 


So how to proceed? 

  • At the beginning of a supplier qualification process, the regulatory requirements regarding the type of material, component or service and the type of product  should be identified and specified. 
  • Audits, if required, should be planned and executed. 

But a successful audit is not the end of the qualification process. After finalising the contract, the compliance of the selected supplier(s) with the applicable requirements should be evaluated periodically. 


Changes at the supplier´s site  that pose a particular risk to the compliance with the requirements should be assessed. 


Brokers also need to be qualified. This should be done taking into account the provisions laid down in the Guidelines  on GDP of medicinal products for human use (2013/C 343/01), Chapter 10 - Specific Provisions for Brokers.


Vendor Approval Checklist

  • Vendor Information Form
  • Procesd Flow Diagram
  • TSE/BSE Declaration
  • Residual Solvents Declaration
  • Regulatory/ GMP certification
  • Stability Data/ Shelf Life/ Retest Period Decleration
  • Documented quality system/ standard

 

Vendor/ Supplier Qualification Process Flow

  • Initial Screening Process
  • Qualification Audit and Supplier Response
  • Management Evaluation
  • Formalized Approval Process
  • On-going Performance Monitoring/Oversight


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