Standard Operating Procedure for Supplier Qualification for Raw Materials in Creams Production
1) Purpose
The purpose of this SOP is to establish guidelines and procedures for the qualification of suppliers providing raw materials for creams production to ensure the quality, safety, and compliance of the materials used in the manufacturing process.
2) Scope
This SOP applies to all suppliers of raw materials used in the production of creams at the manufacturing facility.
3) Responsibilities
The Procurement department is responsible for the initial selection and assessment of suppliers. The Quality Assurance (QA) department is responsible for the evaluation, approval, and ongoing monitoring of qualified suppliers.
4) Procedure
4.1 Supplier Selection
4.1.1 Identify potential suppliers based on their ability to meet the quality, regulatory, and business requirements for raw materials.
4.1.2 Obtain preliminary information from potential suppliers, including certifications, quality control processes, and references.
4.1.3 Perform an initial risk assessment of the supplier based on the criticality of the raw material and the supplier’s history.
4.2 Supplier Evaluation
4.2.1 Conduct an on-site audit of the supplier’s facilities to evaluate their manufacturing practices, quality control systems, and compliance with regulatory requirements.
4.2.2 Review the supplier’s quality documentation, including Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and
4.2.3 Assess the supplier’s capacity to provide consistent quality and supply of raw materials.
4.2.4 Document the findings of the supplier audit and evaluation in a supplier evaluation report.
4.3 Supplier Approval
4.3.1 Based on the evaluation, determine if the supplier meets the necessary requirements for approval.
4.3.2 Approve the supplier by adding them to the approved supplier list (ASL) and notify the supplier of their approval status.
4.3.3 Develop a supplier quality agreement outlining the responsibilities, quality expectations, and compliance requirements.
4.4 Ongoing Supplier Monitoring
4.4.1 Conduct periodic re-evaluations of approved suppliers, including on-site audits and performance reviews.
4.4.2 Monitor the quality of raw materials received from suppliers through incoming inspections and testing.
4.4.3 Track supplier performance, including delivery times, quality issues, and responsiveness to corrective actions.
4.4.4 Maintain records of supplier performance and take corrective actions for any deviations or issues identified.
4.5 Supplier Disqualification
4.5.1 If a supplier fails to meet the quality or regulatory requirements consistently, initiate a review process to determine the need for disqualification.
4.5.2 Notify the supplier of the disqualification and remove them from the approved supplier list (ASL).
4.5.3 Identify and qualify alternative suppliers as necessary to ensure a continuous supply of quality raw materials.
5) Abbreviations, if any
QA: Quality Assurance
CoA: Certificate of Analysis
MSDS: Material Safety Data Sheet
ASL: Approved Supplier List
6) Documents, if any
Supplier Evaluation Reports
Supplier Quality Agreements
Supplier Performance Records
Audit Reports
7) Reference, if any
US FDA CFR (Code of Federal Regulations) Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
ICH Q10: Pharmaceutical Quality System
ISO 9001: Quality Management Systems
8) SOP Version
Version 1.0