Each organisation is responsible for ensuring their vendors provide consistent quality of services and materials which are fit for purpose throughout the product lifecycle from production development right through to commercial distribution. Vendor management is the process of working with vendors, controlling costs and increasing value whilst ensuring quality and managing mitigating risks.
The EU-GMP guideline, Chapter 7 “Outsourced Activities” states that the holder of the Manufacturing Authorization (MA) is responsible for vendor qualification. Similarly, section 1.5.4 of Annex 16 “Certification by a Qualified Person and Batch Release”, of the EU-GMP Guidelines states that the Qualified Person (QP) of the Marketing Authorization Holder (MAH) who is responsible for certifying the drug product for the market is accountable for ensuring all ‘the entire supply chain of the active substance and medicinal product up to the stage of certification is documented and available for the QP’. This document can be viewed at the following link:
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/v4_an16_201510_en.pdf
According to chapter 2 “Personnel” of the EU-GMP Guidelines, the head of Quality Control, Production and Quality Assurance share responsibility for approving and monitoring of vendors as per the following link:
https://ec.europa.ue/health/sites/health/files/files/eudralex/vol-4/2014-03-chapter-2.pdf
Selecting the right vendor and periodic evaluation of the vendor is therefore a critical stage in the product lifecycle to ensure consumer demands for high quality products are met while also meeting high regulatory standards. Industry expectations and regulatory agencies are focusing on a risk-based approach and open communication between both parties in the vendor selection process to help identify gaps and the competency of the vendor.
Vendor management is best defined through a Vendor Management Program and PharmaLex works with Organisations to build a value-added Vendor Management Programme. Some key elements required to support a vendor management programme include:
- Categorisation of vendors according to their level of risk or importance on the quality, efficacy and safety of the final product. High risk vendors should have a more stringent vendor criteria and qualification than that of low risk, non-critical vendors. PharmaLex can support organisations by identifying the priority level of vendors through identifying the vendor regulatory requirements, the vendors associated risk levels on the final product and qualification process best suited for the vendors.
- Vendor selection starts with a definition of the user requirements for the material(s) against which the vendors are assessed. For critical vendors, the vendor selection criteria will be more onerous than for non-critical vendors. A value-added vendor management program should also consider items such as capacity, contingency planning and vendor capability. All information obtained from critical vendors should be assessed by a multidisciplinary team to result in a shortlist of potential vendors.
- A formal assessment of the vendor quality system is required once the short-list of vendors is determined, to establish if the vendor has sufficient evidence of control over their processes. An assessment issued to the vendor helps to identify performance gaps and competency of the vendor. The level of assessment should be commensurate to the risk level of the vendor and PharmaLex can work with organisation to develop appropriate vendor assessments tailored to the vendor risk level. This assessment should be initiated as early as possible in the vendor election process and this point should be factored into the risk assessment for the final product. For non-critical vendors, the quality assessment may be limited to a specific section of the vendor questionnaire and /or the provision of an ISO 9001 or equivalent certificate whereas for vendors which are higher risk and provide critical materials/services, an onsite audit should be performed.
- Audits should be tailored to the vendor service and the vendor quality management system in place, for example GMP, GCP or GDP. The audit on a finished product for example must be performed taking into consideration the potential sales region of the finished product and future potential sales markets. PharmaLex have highly experienced and trained professional auditors who can perform audits to the required standards and provide a customized audit report detailing all the information as required by an organisation, to facilitate a Declaration of GMP Compliance for API vendors.
- Developing contractual Quality and Technical Agreements with vendors where the responsibilities, expectations and processes relative to quality tasks must be outlined to assure the supply of products/service are consistently fit for purpose. PharmaLex can work with vendors to develop the Agreements in accordance with the requirements of section7.14 of the EU-GMP guideline , Chapter 7 “Outsourced Activities”. This specifically states that a contract ‘should be drawn up between the Contract Giver and the Contract Acceptor which specifies their respective responsibilities and communication processes relating to the outsourced activities’. To ensure the vendor understands the organisations expectations, the Agreement must detail all requirements (i.e. KPI’s) to ensure the performance meets expectations thereby ensuring consistent quality product or service is supplied.
- Ongoing monitoring and control of the vendor must be performed after the Agreement has been signed by measuring and monitoring the vendor performance. PharmaLex can establish value added processes for the management and evaluation of vendor performance and work with the organisation to establish corrective actions and vendor process improvements.
- Project managing changes through the impact assessment process to determine if the change poses a compliance risk. PharmaLex can manage these changes by evaluating the changes for impact on GMP and compliance and performing post change evaluation of the change.
Whether you are seeking support with the development of a vendor management process or are seeking to outsource the vendor management oversight element(s) of your organisation our experienced experts are here for you. PharmaLex have built up a wealth of expertise over the years and have a proven record of the ability to deliver in line with their company tagline “Confidence beyond Compliance”. Why not get in touch to find out more on the range of services that we offer by connecting with us on +353 1 846 4742 or email us at contactirl@pharmalex.com.
