Quality Assurance Department
The Quality Assurance Department is mission control for all quality aspects at Ensign. The Q.A department’s six member team approach each new challenge as one, drawing on more than 80 years of combined experience. Customers and Ensign employees can efficiently access any Test Method, Specification, Policy, Form, GMP Contract with absolute confidence that the information is current and accurate. The Q.A team establishes a unique quality plan for each product to ensure it is manufactured as per agreed specifications first time and every time!

Quality Control Chemistry Laboratory
Ensign’s Quality Control Laboratory is armed with both trained analytical chemists and the latest analytical technology. With uniquely skilled chemists and leading analysts, this laboratory continually provides valid results from validated methods. The Q.C Laboratory provides confidence in our manufacturing system and establishes historical trends to be reviewed and facilitate quality product and services. The Q.C Lab is responsible for performing analytical testing on every raw material that is used by Ensign manufacturing, and all intermediary and finished product. Ensign supports this Laboratory with the latest in analytical equipment, which include:

• HPLC - Four latest Waters sytems with Empower software.
• GLC
• NIR
• FTIR
• UV/VIS
• Polarimeter

Microbiology Laboratory
Ensign’s professional team of Microbiologists and Laboratory Technicians diligently monitor our diverse range of products, services and equipment. Responsible for testing every Therapeutic raw material, finished product, in process DI & RO water, environmental air, tank and equipment rinse waters, swabs, contact plates and more.
Further to the day to day testing, the Micro team has been responsible for managing the Ensign Microbiological Task Force. The Task Force focuses on identifying, investigating and preventing potential “risk” areas that could lead to microbiological failures. The Task Force is reflective of Ensign’s commitment to our Quality Assurance Continuous Improvement Policy.

Specifications Department
Ensign’s Specification Department is employed to ensure all manufacturing specifications and associated documents are prepared, maintained and amended using a validated system. This allows for only correct information to appear on Ensign Official Documentation and prevents production of products to undesired specifications.