Pharmaceutical

Quality Assurance Capabilities

General

• design systems to ensure quality output at all stages of processing
• maintain product master files and oversee change control system
• perform full documentation review prior to lot release
• oversee SOP program
• oversee the vendor qualification program
• perform in-house GMP training
• conduct regular self-inspections
• provide feedback to manufacturing on continuous improvement program
• conduct annual product reviews for OTC and prescription drugs sold in Canada and U.S.
• provide design of experiments and statistical analysis support to process optimization initiatives
• responsible for reviewing and approving all validations, either process, analytical method or cleaning 

Quality Control Capabilities

General

• laboratory work undertaken to cGMP requirements
• qualified and well-trained staff committed to customer service
• participation in analytical validation and transfer exercises
• specification of review against current USP and EP compendial requirements
  

Analytical

• HPLC analysis by reversed phase and normal phase techniques
• GC analysis using headspace and conventional techniques
• dissolution testing of finished products including profiling
• disintegration of finished products
• uniformity of dosage units
• refractive index, optical rotation IR and UV spectroscopy
• moisture determinations by KFT and gravimetry
• volumetric and gravimetric analysis
  

Microbiology

• raw material and finished product compendial compliance testing
• environmental monitoring
• micro prep testing development and validation
  

Stability

• design, testing and documentation of stability programs to supports shelf life claims
• storage conditions include room temperature at 25°C and 60% relative humidity, and accelerated studies at 40°C and 75% relative humidity
• statistical evaluation of data
• extrapolation of accelerated data to determine provisional shelf life