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Quality Assurance

A critical element for success

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At Primera, quality is every employee’s responsibility. We consider Quality one of the most critical factors in ensuring our clients’ success for regulatory submissions and patient safety.

  • Comprehensive Quality System to ensure full compliance with ICH and FDA regulations and industry guidelines.
  • We maintain an ongoing assessment of quality through the use of internal audit programs:

    • Weekly Audits – Focus on compliant labeling for reagents/solutions and general laboratory practices.
    • Monthly Audits – In addition to tasks performed in the weekly audits, Primera will review logbooks, a random data package, safety checks, calibrations stickers and service provider lists as part of the monthly audits.
    • Semi-Annual Audits – A more in-depth review takes place over multiple days that include tasks performed in the weekly and monthly audits, plus review of training records, maintenance and calibration records, sample receipt documentation, document control, SOPs, and quality assurance operations.
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Guidances

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  • FDA/EMA GMP & GLP
  • ICH Guidelines
  • FDA 21 CFR Part 11, 58, 320,  210, 211, 820, etc.
  • FDA Guidelines to Industry for Bioanalytical Method Validation (2018)
  • EMA Guidelines on Validation of Bioanalytical Methods
  • Data Integrity – ALCOA+

Regulatory History

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  • FDA registered and inspected cGMP and GLP Contract Laboratory
  • DEA Registered for Controlled Substances Schedule I-V
  • Health Canada Inspected
  • Frequent In person and virtual audits by global and domestic brand, innovator and generic companies.
  • We are in good standing with the FDA for both general audits and PAIs:

FDA Inspections

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Training

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Training is a critical aspect of Primera’s onboarding process. Prior to conducting any lab work, all newly hired employees must complete their SOP curriculum and their technical and safety training. Method specific training is rigorous and consists of four phases (Reading and understanding the method, observing the trainer perform the method, side-by-side performance with the trainer, and independent performance by the trainee).  We strictly adhere to these practices to ensure regulatory compliance and a high level of data quality and integrity.

In addition to new employee training, Primera annually utilizes regulatory consultants to conduct refresher training for our employees on current cGMP and GLP practices. This ensures that Primera remains current on any changes that have been implemented in the regulations and guidances.

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