- What: Merck KGaA takes a comprehensive approach to building manufacturing capacity, including processes for identifying skills gaps and providing targeted training, and extra support for third-party manufacturing plant managers.
- Objective: It is designed to ensure that all its manufacturers (in-house and contracted third-parties) meet the same quality standard.
- Scope: The approach is global and is not limited to a specific type of product or manufacturing process.
- Details: The same quality system has been implemented in all six in-house manufacturing sites and 53 third-party contract manufacturing organisations in scope of the Access to Medicine Index 2016.
Merck KGaA applies a single quality standard to all its manufacturers (in-house and contracted third-parties) through its “ONE quality system.” The system includes comprehensive processes for auditing, training (which is tailored for each site, to address the gaps and needs identified through audits), quality control monitoring, and technology transfers, and is facilitated by an extensive global information-sharing system. For example, when a health authority inspects one of Merck KGaA’s sites, the findings of that inspection are immediately shared across all other sites worldwide. Each site then assesses if it needs to implement similar changes, without the need for an individual inspection. This process also allows best practices to be shared across sites.
In addition, the company’s Virtual Plant Team (also recognised as best practice in the Access to Medicine Index 2014) provides an additional layer of support, expertise and regular training to third-party plant managers.
In countries in scope of the Index, the ONE quality system has been implemented in all six in-house manufacturing sites (in Brazil, China, India, Mexico and Pakistan) and 53 third-party contract manufacturing organisations (in Brazil, China, Colombia, Egypt, India, Iran, Mexico, Morocco, Pakistan, Peru, Philippines and Thailand). The Virtual Plant Team is in operation in a subset of these third-party manufacturers.
Merck KGaA’s commitment to and process for building capacity of both in-house and third-party manufacturers in countries in scope of the Index is significantly stronger than peers: it is notable for its focus on understanding and responding to local manufacturers’ needs, global communication channels, and specific expertise provided to third-party manufacturers.