Supplier Qualification in Pharma: The 4-Step Process Explained

Regulatory bodies of major markets including EMA, US FDA, Health Canada, Brazil’s ANVISA, India’s CDSCO and Mexico’s COFEPRIS all require an appropriate and robust Pharmaceutical Quality System (PQS) for the manufacture of medicinal products to ensure product safety and quality. Manufacturers should ensure that proper arrangements are in place for the manufacture, supply and use of the correct starting and packaging materials. This includes the selection and monitoring of suppliers for materials and services, and verifying that each delivery is from the approved supply chain.

To achieve this, pharma manufacturers should have a robust supplier qualification policy. In this article, the four steps of supplier qualification in the pharmaceutical industry will be explained.

H2: Four steps of supplier qualification

To maintain a high level of integrity of supply chains, the quality requirements established by the pharma manufacturer for the starting materials should be discussed and agreed upon with the suppliers. Appropriate aspects of the production, testing and control, including handling, labelling, packaging and distribution requirements, complaints, recalls and rejection procedures should be documented in a formal quality agreement and specifications.

Based on the requirements described in the standards, supplier qualification shall consist of the following four steps:

Step 1: Supplier Selection
Step 2: Supplier Qualification
Step 3: Supplier Monitoring
Step 4: Re-qualification

H2: Step 1: Supplier selection based on risk assessment

Supplier selection is the process of evaluating and approving the right suppliers to provide specific materials or services to the pharma manufacturers while meeting all regulatory compliance requirements. This has to be carried out according to the level of risks associated with the products or services to be purchased. For example, if the product is an active pharmaceutical ingredient (API), the criticality for the final product is much higher than that of an excipient, and for this reason, the criteria used to select the suppliers will be different.

During the selection process, it is important to consider several factors that might impact on the supply chain, which mostly include:

What is the risk level of the materials/ product/ service to the finished product’s quality, efficiency and safety?
Can the supplier meet the required specifications?
What certifications does the supplier possess?
Is the supplier exclusive to the material supplied?
Where is the supplier located? What will the supply chain be like?
What is the price?

H2: Step 2: Supplier qualification

After determining the criteria for supplier selection, manufacturers will need to assess the criticality of suppliers and implement corresponding qualification processes. Before the qualification is completed, purchase of materials cannot begin.

The higher the criticality of the suppliers, the more stringent the qualification control should be in place. In the example mentioned before, in the case of API, qualification is commonly carried out through on-site audits, but for an excipient, paper-based questionnaire might be sufficient.

The two most common types of qualification processes are audits and documentation review.

H3: Audits in pharma supplier qualification

Audits can be carried out on site or remotely by internal auditors of the pharm manufacturer or third-party companies that provide independent auditing services. During the audit, it is essential to evaluate the supplier’s GxP system according to the specifications, and identify quality evidence for all processes associated with the product manufacturing or service provision. It is mandatory to have a rationale that describes when on-site and remote audits are applicable.

Audits have to be carried out by qualified auditors who are experienced professionals well-trained in the standards and processes being audited, and who possess solid experience in conducting audits.

Planning of the audits is crucial to ensure that the scheduled duration allows the full evaluation of the audit scope, providing a full and clear assessment of GxP compliance. For starting materials, particular focus should be given to potential cross-contamination from other materials/products/processes on-site. The report should fully reflect what is reviewed and seen during the audit, with any deficiencies clearly identified. Any required corrective and preventive actions should be implemented by the suppliers within the agreed timeframe.

H3: Documentation review in pharma supplier qualification

Documentation review can be carried out when the material, service or process supplied is not considered critical to the final product being manufactured. The evaluation typically consists of a review of GxP documents, such as quality questionnaires, certificates, critical standard operational procedures (SOP) and other related documentation.

Similarly, the documentation review has to be performed by a qualified professional who is familiar with the applicable standards and documentation related to the product, process or service supplied.

After completing the qualification step, suppliers enter the approval process which determines their qualification status based on the established requirements, namely:

Approved: meaning that the supplier meets the standards and fulfils the customer’s requirements.
Partially Approved: meaning that some processes need to be improved, whether due to customer requests or/and non-conformity with the standard.
Not Approved: meaning that the supplier does not meet the standards or/and the customer’s requirements.

Once qualification is carried out and the supplier is approved or partially approved, first orders of materials can be provided to the supplier. If the supplier is not approved, pharma manufacturers will need to source a new supplier and conduct the qualification process again.

H2: Step 3: Supplier monitoring

Monitoring refers to the periodic evaluation of the supplier in order to assure that the services, products or processes offered still meet the customer’s requests and the specification. In this stage, it is equally important to have a risk-based rationale that defines the frequency and criteria for how this monitoring process can be applied to different suppliers, while maintaining operational efficiency and supply chain integrity.

Pharma manufacturers usually take quality and supply parameters such as those listed below into consideration when establishing the risk matrix:

The quality of the deliveries
The on-time delivery rate
Whether the quantities requested were properly fulfilled
Number of non-conformities in previous qualification process
Where non-conformities were identified, how effectively and quick they were closed
Whether the certifications of the company have been maintained
The price level
And lastly, the overall relationship with the supplier

H2: Step 4: Re-qualification

Periodic re-qualification of a supplier should be performed based on results of risk assessment, the type of supplier and supplier materials or service provided.

Re-qualification essentially means re-running the entire qualification process for the same supplier against the latest standards and requirements. It is fundamental to verify suppliers’ compliance with the company’s requirements on an ongoing basis. How frequently the re-qualification should be performed is again determined by the risk level of the suppliers and supplied products/services. It can be on-site re-audit of a supplier or documentation review.

The selection, qualification, approval, and maintenance of suppliers of starting materials or services, together with their purchase and acceptance, should be documented as part of the pharmaceutical quality system. The level of supervision should be proportionate to the risks posed by the individual materials, taking into account of their source, manufacturing process, supply chain complexity and the final use to which the material is put in the medicinal product. The supporting evidence for each supplier and material approval should be maintained. Staff involved in these activities should have a current knowledge of the suppliers, the supply chain and the associated risks.

From a single GMP audit to the development of a full supplier qualification programme, we support the pharmaceutical industry’s quality assurance commitment at each critical point. Check out our GxP Library if you are looking for an audit, or contact us if you need a customised solution.

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