Vendor approval is a routine activity in the pharmaceutical industry where a new vendor is added for a material with predefined specifications. The process involves a series of sequential activities, including material quality, feasibility, and regulatory assessment. The vendor approval activities mainly start from the supply chain department, which consults with the formulation development department for sample handover to develop a new source as well as an alternative source of material.
Vendor approval activities mainly start from the supply chain department. Where supply chain shall consult with the formulation development department for sample handover to develop a new source as well as an alternative source of a material. After receiving the sample formulation department personnel shall submit the sample to the analytical department for initial analysis of raw material.
After analysis of the material, a formulator shall execute a trial batch and initiate a stability study at accelerated conditions for 6M. If trial batch/stability study is not mandatory, then FD shall prepare a risk assessment/justification and communicate with the QA department to go ahead for the approval of the vendor based on the Analytical test report and Formulation trial report (as applicable) through the request form.
Then QA will coordinate with Supply Chain to collect the documents from the vendor as per the predefined checklist. After receiving all required documents QA will approve the vendor in the system.
Document/Information required from the R&D department as a part of new Vendor approval activities are mentioned below:
- Sample submission: After receiving the sample, the formulation department personnel shall submit the sample to the analytical department for initial analysis of raw material.
- Trial batch execution: After analysis of the material, a formulator shall execute a trial batch and initiate a stability study at accelerated conditions for 6 months.
- Risk assessment: If a trial batch/stability study is not mandatory, then the formulation development department shall prepare a risk assessment/justification and communicate with the QA department to go ahead with the approval of the vendor based on the analytical test report and formulation trial report (as applicable) through the request form.
- Document collection: QA will coordinate with the supply chain to collect the documents from the vendor as per the predefined checklist.
- Approval: After receiving all required documents, QA will approve the vendor in the system.
The following documents/information are required from the R&D department as a part of new vendor approval activities:
- Lab trial report
- Analytical report
- Microbial report (if required)
- Stability data
- Comparative study of materials (for an alternate source of API/two or more vendors)
- Vendor assessment report
The following documents/information are required from a supplier as a part of new vendor approval activities:
- cGMP Certificate
- BSE/TSE Certification
- Residual Solvent statement
- Melamine-free Certifications statement
- Iron content declaration
- Risk assessment and control strategy/Statement for elemental impurity
- Risk assessment and control strategy/Statement for Nitrosamine impurity
- Food grade certificate for packaging materials
Based on the above assessment and documents of a material, the QA or vendor approval department will decide whether to approve a vendor or not.
In conclusion, the vendor approval process in the pharmaceutical industry is a crucial step to ensure the quality and safety of the materials used in the production of drugs. The process involves a series of sequential activities, including material quality, feasibility, and regulatory assessment, and requires the collection of various documents and information from both the R&D department and the supplier. The process ensures that the vendor meets the predefined specifications and is approved by the QA or vendor approval department before being added as a new vendor.
ALSO READ: SOP for Vendor Qualification and Approval
Tags
Quality Assurance
