GMP Compliance overview

With processes developed over 25+ years, Q&C can tailor our services to deliver the most efficient and cost-effective approach to your project. Up to 70% of our business is repeat, because we deliver results. From large, multi-faceted quality initiatives to the most specialized tasks, we bring deep expertise, complimentary skill sets, and built in back-up to every assignment.


Health Canada Remediation

If you have lost your licence or risk losing it, our knowledgeable guidance, strong reputation, and GMP regulatory compliance expertise can help you stay in business. 

As an example, a major drug manufacturer was issued a non-compliant rating by Health Canada. They needed to address their issues quickly to keep production running, so they engaged Q&C to take control of Quality functions, assume various Quality roles, and plead their case with Health Canada. We helped save the client from closure, continue to meet their supply demands and receive a compliant rating in under 12 months—a rating they’ve received every year since.

Is your licence in jeopardy?


Phased GMP for Drug Development

From R&D to Commercialization –
Q&C Services can help

Regulators like Health Canada and the FDA expect drug developers to progressively apply Good Manufacturing Practice (GMP) quality systems to drugs as they advance through different development stages.

With 30 years of GMP consulting experience encompassing all aspects of GMP, Q&C services can help you implement the GMPs that are appropriate and expected at each phase - from early development up to and including commercialization.

We’re experts in the phase-appropriate implementation of GMPs.
See how we can help!

STANDARDS WE WORK WITH:

Health Canada’s GUI-0036-Annex 13

Good Laboratory Practices

Good Clinical Practices

Requirements we help with include:

  • GMPs & GLPs

Fractional VP/Interim services

Quality system setup including:

  • Good documentation practices

  • Analytical method validation

  • Equipment qualification

  • Labelling controls

  • Traceability

  • Specifications

  • Documentation of manufacturing processes

  • Raw material control

  • Vendor qualification

  • Facility qualification

  • Cleaning/sanitization programs

  • Process validation

  • Importing

Clinical trial materials

APIs

  • Regulatory

Pharmacovigilance

Clinical Trial Applications

See how Q&C services can help you start and stay compliant.

Call us today.


Backlogs

Q&C recognizes that keeping up with day-to-day production and distribution activities can be time-consuming and, unfortunately, can result in backlogs. That’s why we have dedicated resources to clean up your backlogs, including:

  • Complaints and adverse events

  • APQRs (Annual Product Quality Reviews)

  • CAPAs (Corrective and preventive actions)

  • Change controls

  • Deviations

  • Batch record reviews

  • Product release

  • Stability

  • Environmental monitoring

  • Vendor qualification programs

Let us clean up your backlogs


Fractional VP of Quality/Interim Services

Let Q&C Services provide the expertise you need, when you need it. 

Fractional VP/Head of Quality

Hiring a full-time VP/Head of Quality can be expensive. Q&C Services’ fractional VP/Head of Quality Services offer an efficient and cost-effective way to access specialized expertise, scale operations, and overcome various challenges while contributing to your organization’s growth and success. 

Q&C Services can fill fractional VP/Head of Quality and other GMP roles, offering benefits such as:

  • Cost savings: Access high-level expertise and experience at a fraction of the cost

  • Flexibility: Engage professionals for specific projects, busy periods, or on a part-time basis without the long-term commitment of a permanent hire

  • Specialized expertise: Save time and resources while getting the specialized skill set you need, when you need it

  • Instant availability: Avoid the lengthy hiring process and get specialists working on projects immediately

  • Scalability: Get help scaling your business without having to onboard new employees

  • Knowledge transfer: Fractional professionals’ knowledge is transferred within the organization and includes best practices, industry insights, contacts, and perspectives that can help train internal resources and help access new opportunities even after their engagement ends

  • Industry networks: Extensive networks and contacts within respective industries can help companies looking to expand their reach and access new opportunities

  • Objectivity: Fractional professionals offer an unbiased perspective and fresh insights that can help identify and address issues that may have been overlooked

See how a Fractional VP/Head of Quality can help support your business.

Interim Services

Our senior consultants and leadership are seasoned industry and quality leaders.

They can step in to address your current needs and reduce compliance risks by identifying and fixing issues before they become large and expensive to reverse.

Our experts can:

  • Set up your Quality Control Department

  • Assist existing Quality Personnel with backlogs and audits

  • Serve as your Interim QCO during times of transition

  • Offer skills in Quality Assurance and Laboratory Management

What’s the difference between Fractional VP and Interim Services?

While both services provide support for your teams, they differ in terms of the roles they support. Fractional VP of Quality provides executive-level, strategic support, while interim/backfill services can be more focused on a specific skill set such as laboratory management.

While interim resources provide essential immediate support during medical leaves or talent searches, Fractional VP services extend beyond short-term requirements, ensuring operational continuity and elevating day-to-day operations through strategic partnership.

A Fractional VP brings a profound impact with long-term industry insights, strategic guidance, and knowledge transfer, making them an indispensable asset for sustained growth and excellence.

See how our experienced team can help


Quality System Restructuring

Q&C believes that having industry-leading Quality doesn’t necessarily have to mean higher costs. Our specialists can help you improve the overall effectiveness of your Quality System while prioritizing your investments, so that what you spend on quality is highly effective at every stage.

See how we can improve your Quality System


Data Integrity & Software Validation

Regulators expect all activities and data that support GMP decisions to be electronically recorded and that all data generated, manipulated, stored, and retrieved to be demonstrated as authentic. Careful management and understanding of your electronic systems is a requirement. This applies to anyone who conducts GMP activities using electronic systems (and/or decides which systems are to be used and controlled, such as IT Professionals or QA/QC)—including Pharmaceutical Fabricators, Packagers, Labellers, Test Laboratories, Importers, Distributors, and Wholesalers. 

Q&C can establish controls to prevent and detect falsification of data, and to validate your electronic systems for the intended purpose, including:

  • Analytical and production equipment

  • Warehouse management systems (WMS)

  • Enterprise Resource Planning (ERP) software (e.g. SAP)

  • Temperature monitoring systems

  • Building systems (e.g., HVAC, pressure, humidity)

  • Labelling and packaging systems

  • GMP process management systems

  • Cloud-based systems for data storage and e-signature

Validate your data and software


Electronic Systems Management

Along with validating your electronic system for its intended use, Q&C can help you understand the system, GMP usage and risks to patient and product. With our knowledge and expertise, we can help you purchase appropriately, control the content within the system, and verify that the system is being used appropriately throughout the system and product life cycle.

Make sure your GVP systems measure up


Quality Agreements

We write and negotiate Quality Agreements meeting Health Canada expectations/requirements to define the roles and responsibilities of a drug company and its contracted facilities. These Quality Agreements help ensure every party engaged in the manufacturing of a drug product is responsible for its compliance for the activities it performs.

Let’s create your Quality Agreements


Validation

A vital element of quality assurance, GMP validation ensures that your products and processes are absolutely fit for intended use. We can help you verify that your facilities, procedures, processes and activities perform as intended and document that the processes, methods, tests, activities and equipment they deploy are capable of repeatedly producing the desired result.

Learn more about our validation services