Contract Manufacturer and Supplier Management

Having been involved in selection, qualification and monitoring of suppliers for many years, this topic holds very few secrets for us. In addition, we followed professional training on the topic, that covered Integrated and Efficient Supplier Qualification, and which included a specific look at India and China. We provide support on all aspects of the supplier quality management, outsourcing and will map complex supply chains.

Audits

We can execute qualification, requalification and monitoring audits and will deliver comprehensive reports with sufficient level of detail and where any deficiencies are properly identified. If required, follow up can be supported to ensure deficiencies are addressed on time so that the external party will not become a GMP risk once production starts.

Selection and qualification

During the selection process we can join technical visits to understand whether the CMO or supplier can meet your requirements. During this phase attention will also be given to the supply chain to your site(s) to ensure compliance with the Good Distribution Practice requirements.

Monitoring

Knowing the intricacies of supplier risk management, we can implement a system that will categorize suppliers and external manufacturers based on risk ensuring that the appropriate level of attention is given and resources can be adequately assigned.

Tech Transfer

We partner with the applicable internal organisations (for example Quality Control, Development) as well as the external organisation to ensure technology transfer protocols and reports are compliant, and aligned with requirements.

Relationship management

Critical suppliers require special attention. If your organisation requires support in this area we can provide that. We will partner with the external party to ensure processes run smoothly, complaints are handled timely, and issues are resolved adequately. If needed we hold periodic (weekly/ montly) meetings, these are typically teleconferences, but on-site can also be supported.

Quality Agreements

Quality Agreements are the backbone of any GMP collaboration and receive increased attention from regulatory agencies such as the US FDA. Having negotiated many quality agreements, we can lead negotiations, provide templates and work out the details together with the external party so that a robust document can be agreed upon.