Risk communication
After the supplier risks have been identified, reduced to acceptable levels, and communicated, it is important to establish
a formal agreement to ensure that the supplier maintains a state of control and the manufacturer is an active participant
in the supplier's quality- and risk-management programs. An effective way to establish this relationship is through a quality
agreement. The quality agreement is a contract between the pharmaceutical manufacturer and its supplier of critical components
or materials used during the development and manufacturing processes. The purpose of a quality agreement is to clearly define
supplier qualification requirements, product and process specifications, regulatory-compliance requirements, management responsibility,
a risk-management plan and a comprehensive communication plan.
The quality agreement should also specify the manufacturer's expectations for processing changes that the supplier considers.
The supplier should inform the pharmaceutical manufacturer of proposed changes to their manufacturing process in a "Notification
of Change." The pharmaceutical manufacturer can thus evaluate the impact of the change on its final product. The manufacturer's
previously identified management team should approve the change before the supplier implements it. Even the smallest change
to a supplier's process can have an immense effect on a manufacturer's product or process. Establishing and maintaining a
quality agreement is essential to controlling this potential risk.
Once established, the quality agreement should be periodically reviewed and monitored for effectiveness. Predetermined quality
criteria such as the number of products out of specification, CAPA, and the number of product complaints should be measured,
and trends should be investigated. The quality agreement must be evaluated regularly to ensure that required updates are implemented
and communicated to each party in a timely manner.
Risk review
In addition to monitoring quality criteria, it is recommended that the manufacturer conduct periodic supplier audits to ensure
and verify that the supplier is maintaining a state of control, meeting the pharmaceutical manufacturer's requirements, and
employing a quality-management review system. The manufacturer should evaluate its suppliers according to defined criteria
and procedures. Results should be documented. Each supplier that a manufacturer selects should have a demonstrated capability
of providing products or services that meet the established requirements specified in the quality agreement. Once a supplier
is selected, its performance must be monitored periodically. The frequency of monitoring should be commensurate with the significance
of the product or service the supplier provides. The complexity of the service and its potential effect on the finished product's
performance also should be considered.
Planning for a supplier audit is critical. Supplier audits should be scheduled according to the product and process risk assessments.
The interval between audits should be established according to the significance of the material for final-product performance
and the supplier's demonstrated ability to manufacture to the specified requirements consistently. An evaluation of the supplier's
past history in providing similar products or services should be included in the assessment when possible. Written mail surveys
or questionnaires frequently are used to assess the supplier's quality plan, test and inspection procedures, validation history
and references, and the results of previous regulatory inspections or registration audits. Often, one set of questions will
not fit all suppliers. Also, the focus of supplier audits can evolve as the relationship between the manufacturer and supplier
matures. Though previous relationships with a supplier and registration to a specific industry standard such as ISO 9001 are
important to manufacturers, they should not rely solely on previous audits and certifications as evidence that a supplier
can provide acceptable products. Instead, manufacturers should conduct on-site supplier audits to assess supplier risk and
establish conformance.
The supplier audit helps identify nonconformances that occur in many processes throughout the product life cycle—from the
design process to the manufacturing process to the distribution process. Supplier audits can build both parties' confidence
and provide a system for high-quality technology transfer.
In addition, an audit helps the supplier understand the pharmaceutical manufacturer's expectations. Supplier audits generally
provide objective analyses of the vendors and can be fact gathering tools to ensure that the supplier meets the manufacturer's
expectations, thus enabling control over the quality of the product.
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