Of all the subsystems of a Pharmaceutical Quality System, the Materials Management subsystem may require the most cross-functional collaboration and teamwork. For example, the Materials Management subsystem does not simply apply to warehouse personnel. This subsystem includes the warehouse personnel who receive, store and handle components and raw materials and distribute final products, but it also includes the purchasers who buy components from qualified vendors, the manufacturing workers who request and receive components and transfer final products to the warehouse, the quality assurance specialists responsible for component and lot release, and the quality control employees who sample and test components and products. As you can imagine, it takes a lot of different people working together to properly manage materials.
How well do you manage your materials? In our experience, we’ve found that pharmaceutical manufacturers often stumble in a few key areas of materials management. Kymanox can help you avoid surprisingly common pitfalls for pharmaceutical manufacturers navigating the new, global supply chain.
There are compelling business, quality, and regulatory reasons for appropriately managing your materials and components. Besides the cost considerations and damage to a company’s reputation that can result from poor quality, drug manufacturers are responsible for assuring their product, materials and components meet their established specifications and that they have been produced in a Quality System environment that will not have a deleterious effect on the safety or efficacy of the finished product. Utilizing a risk-based approach and following current best practices to manage supplier quality can help you assure efficient and effective management of contract operations, suppliers, vendors, and services.
Kymanox’s broad expertise in implementing efficient, effective, and sustainable policies, processes and procedures will ensure your Materials Management program includes all of the necessary compliance elements to meet the satisfaction of the internal and external customers it supports and serves, along with meeting the compliance requirements for today’s regulatory environment.