To comply with the requirements of GMP, manufacturers must ensure that any material or service providers that they use are able to meet strict quality standards. This is due to the potential impact of materials or services on the quality of a final therapeutic product.
Achieving this standard requires that a number of procedures are included in your quality management documentation to ensure that suppliers for your GMP products are properly assessed and continuously monitored.
Supplier Qualification & Management
Supplier qualification is the process by which external suppliers are assessed to ensure the supply of products or services to sufficient quality. This process may also be known as vendor management.
The qualification process requires that all suppliers of GMP materials or services are:
|1. Assessed||When a new vendor is identified, its ability to meet GMP requirements should be formally assessed|
|2. Risk managed||Evaluation of the vendor’s response must determine their risk classification based on the maturity and compliance of their quality management system and the potential level of impact of the product or service being provided|
|3. Approved||Those suppliers that meet the required quality standard should be formally approved and added to an Approved Supplier List.|
|4. Monitored||Those vendors who are approved for use must be continuously monitored through ongoing audits and assessment of supply history|
Supplier Qualification and the Quality Management System
The process for supplier qualification should be documented in an approved procedure.
For more on Supplier Qualification requirements in GMP environments, complete the Supplier Qualification Certificate GMP Training Course.
This procedure may also involve other quality management processes, for example:
- The qualification of a new supplier or changes to an existing supplier should be documented in a change control
- The purchase order process should require personnel to check the approval status of a vendor before ordering
- Documented risk assessments should be performed to determine which suppliers have a direct, indirect or no impact to product quality
- Supplier questionnaire forms may be created and used to assess a supplier’s capability and determine if an on-site or remote audit is required prior to approval
- Once approved, a written GMP agreement should be signed by both parties outlining the technical arrangements related to the material or service being provided
|Examples of Direct Impact Suppliers:||Examples of Indirect Impact Suppliers:||Examples of Minimal or No Impact Suppliers:|
You should maintain a Supplier File for each supplier, regardless of their approval status (approved, conditionally approved, not approved) which might include:
- Supply agreements for business responsibilities
- Copies of insurance documents
- Financial reviews
- Manufacturing/ supply chain flowchart
- Site Master File
- A copy of the supplier’s GMP licence or certificate
- Examples of Certificates of Analysis and product specifications
- Completed qualification questionnaire and supporting documentation
Reducing the risk to patients and the business
Assessing your vendors prior to engaging them reduces the risk of negative impact from materials or services being supplied to a lesser standard than what is required. This is essential for maintaining product quality and patient safety, and also reduces business risk.
Some useful regulatory guidelines include:
- PIC/S Guide to GMP – Part I: Chapter 5 – Production (Starting materials and packaging materials), Chapter 7 – Outsourced Activities
- PICS/ Guide to GMP – Part II: Chapter 7 – Materials Management
- ISO 13485 – Clause 7.4.1 Purchasing process, 7.4.2 Purchasing information, 7.4.3 Verification of purchased products
- FDA Quality System Regulation 21 CFR Part 820.50 – Purchasing controls
To get started on your supplier assurance journey, why not sign up for one of PharmOut’s e-learning modules?
Additionally, PharmOut regularly conduct on-site and remote supplier audits on behalf of our clients. Our auditors have experience in PIC/S GMP requirements, ISO 13485, ISO 22442, EU Medical Device Regulation (EU MDR) and Medical Device Single Audit Program (MDSAP).