Manufacturing Services

Support Services

Quality is the foundation upon which DRAXIS Pharma has built its reputation.  Today, we meet or exceed current Good Manufacturing Practices (cGMP) and continue to invest in our people, processes and equipment to ensure that we remain an industry leader.

Quality Control performs product and material testing, environmental monitoring, analytical method validation and a full range of stability programs. This group is supported by in-house chemistry and microbiology analytical laboratories.

Quality Assurance / Quality System is responsible for batch document reviews, standard operating procedures, material and product specifications and releases, audit management, training and change control administration.

Validation ensures that equipment qualification (IQ/OQ/PQ), computerized systems validation (including Part 11 compliance), cleaning and process validation standards are applied and maintained.

Regulatory Affairs supports our clients in the preparation and submission of regulatory filings and maintains internal regulatory requirements.