Quality and Assurance

The pharmaceutical quality control laboratory serves
one of the most important functions in pharmaceutical
production and control. A significant portion of the
CGMP regulations pertain to the quality control laboratory
and product testing. Similar concepts apply to bulk drugs.

An effective pharmaceutical quality system should help ensure
compliance with cGMPs by focusing on:

  • Quality management
  • Quality assurance
  • Evaluation analysis and quality risk management tools
  • Preventive action
  • Risk management
  • Continuous improvement
A modern pharmaceutical quality system looks like a hub and spokes of a wheel. The quality system itself is at the center (the hub), but it is connected to five other manufacturing systems (the spokes). When you include the quality system as a subsystem at the center of it all, the six subsystems of a modern pharmaceutical quality system are the:
  • Quality System
  • Production System
  • Facilities and Equipment System
  • Laboratory Controls System
  • Materials System
  • Packaging and Labeling System
The quality subsystem at the center provides the foundation for the five manufacturing subsystems and helps them achieve compliance. Each subsystem has an impact on the others and they all have to work together to consistently produce a quality product.

In the end, firms with strong quality systems will be more likely to meet and exceed C-GMPs while also enjoying many other advantages, including improved product and process understanding for better decision making; continuous improvement; the ability to manage change to prevent unintended consequences; minimized product variability; enhanced test method accuracy; reduced costs due to fewer investigations, deviations and rejections; minimized product loss and costs associated with scrap, disposal, rework and recalls; reduced downtime with more reliable equipment and fewer repair interruptions; and decreased labor costs associated with automation of manufacturing processes.

Our Canadian ,American and international manufacturers combine decades of pharmaceutical formulation development expertise with leading-edge technologies to provide the best solutions to our customer needs .Our network of expertise in the pharmaceutical manufacturing field allows our customers to focus on the business end of their operation, knowing that their world class trusted product is being produced by the highest quality manufacturers .Our CDMOS are highly respected C-GMP complaint companies, licensed and inspected by regulatory authorities such as Health Canada Therapeutic Directorate, US FDA, EMA....etc

What We Do

Quality and Assurance

Lepharm Advantage