Quality

While all Apotex employees have a role in product quality, the Quality group has some specific duties in this area.

Specifically, Quality is responsible for:

• Ensuring that Apotex products are produced in accordance with government marketing approvals and meet their specification requirements.
• Ensuring that all facilities producing Apotex products, and production operations, comply with pharmaceutical good manufacturing practice (GMP) regulations.
• Approving all decisions which could effect the safety, efficacy or quality of Apotex products.

These primary functions of the group reflect the legal requirements for the sale of pharmaceuticals and support Apotex’s mission of producing high quality products.

The Quality Division is divided into three main functional areas. These operate to support either solid dose or liquid dose production and packaging or both depending on the specific activity. The main areas are: Quality Assurance, QA Supply Chain and QA Validation.

Quality Assurance
Staff in the Quality Assurance group own and/or support a variety of GMP processes including conducting supplier and internal audits, hosting audits of Apotex by regulatory bodies and customers, approval of changes to products and procedures, investigating and responding to customer complaints, product review, product recall and management of the commercial product stability program.

Supply Chain
Personal in the QA Supply Chain group work with production, packaging and distribution staff to build quality into every Apotex product from the receipt of raw materials through packaging and shipment of product to the customer. Specific personal in the Product Release department are responsible for the release of all materials used in the manufacture of Apotex product and the release of finished product to the market. This group also owns the deviations process and works with all parts of the business in this area to ensure that issues are investigated and addressed.

Validation
Employees in Validation provide documented evidence that our manufacturing processes, facility systems, equipment, cleaning processes and computer systems continuously produce the desired results. In addition to being a GMP requirement validation studies enhance understanding and support continuing improvement initiatives.