1. Purpose:
The purpose of this standard operating procedure (SOP) is to ensure that all raw material suppliers are qualified, evaluated and approved prior to their use in our company’s products.
2. Scope:
This SOP applies to all raw materials used in our company’s products, including but not limited to active pharmaceutical ingredients (API), excipients, packaging materials, and any other raw materials that may impact product quality.
3. Responsibility:
The Quality Assurance (QA) department is responsible for ensuring compliance with this SOP and tracking the qualification of raw material suppliers.
4. Raw Material Supplier Qualification Procedure:
4.1 Raw Material Supplier Identification:
The purchasing department is responsible for identifying all raw material suppliers through various sources like databases, registers, supplier directories, referrals, existing supplier’s recommendation, etc.
4.2 Initial Supplier Approval:
The QA department is responsible for evaluating each supplier’s suitability and capability to supply raw materials that meet our company’s requirements.
• A potential supplier questionnaire is developed to gather all the necessary information from potential suppliers.
• Audit reports, certification, and any other relevant documentation shall be obtained from the supplier for review.
• The production department and regulatory affairs team shall be consulted for product-specific regulatory or safety requirements.
• A technical evaluation of the supplier’s manufacturing process, quality control, and quality assurance systems shall be carried out to verify that they are capable of supplying materials that meet our specifications.
• Suppliers who meet all the criteria shall be approved as qualified suppliers and documentation shall be maintained for each approved supplier.
4.3 Purchasing and Receiving:
• Purchasing must order raw materials from suppliers approved as per 4.2.
• Purchasing must verify that the raw material is received from an approved supplier.
• Unless it is a previously qualified, approved, and validated raw material, it should be subjected to testing as described in the respective test procedure.
4.4 Supplier Performance Monitoring:
The performance of each qualified supplier shall be monitored on an ongoing basis.
• The QA department shall maintain a supplier performance monitoring program and records for various quality metrics.
• Supplier corrective action requests (SCARs) shall be initiated if the supplier fails to meet the quality requirements as described in the purchase order or agreed upon specifications.
• The SCAR and its closure shall be documented and shared with purchasing for its information or follow-up discussion, as needed.
• Supplier performance shall be reviewed regularly with a view to continuous improvement.
5. Records:
All relevant records shall be maintained in a secure and systematic manner.
6. Distribution:
This SOP and its related attachments shall be distributed to those personnel who require access to it for the performance of their tasks.
7. Training Requirement:
This SOP shall be included in the new employee orientation program, and refresher training shall be given at least once every 3 years to employees involved in purchasing or QA functions.
8. Review and Revision:
This SOP will be reviewed annually or when required and updated as per the documented change control procedure.
9. Abbreviations and Definitions:
API: Active Pharmaceutical Ingredients
QA: Quality Assurance
SCAR: Supplier Corrective Action Request
SOP: Standard Operating Procedure
