Consider Outsourcing Your Quality Unit for Peace of Mind
Outsourcing Quality Unit Roles
While it’s true that staffing in-house quality staff can be more efficient but, the results are not always expected. However, it can lead to surprising expenses, which you only discover when it’s too late when you try to fix it by replacing your quality unit staff. Outsourcing to RAQA for quality functions, on the other hand, can provide a more predictable cost structure, enhanced quality responsibilities, minimise non-conformance deviations, and potentially save you money in the long run.
Designated Quality Unit
You can designate the responsibilities and authorities of quality to RAQA. As such, we will manage and run all your quality assurance and control, minimising the hassle of dealing with potential drama after catastrophic events.
By outsourcing the quality unit to us, we can do the following for your manufacturing operations:
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- We handle all quality control, including approving and rejecting activities, in-process testing, and final product testing.
- Finished product testing and release activities, such as approving or rejecting all procedures or specifications impacting the drug product’s identity, strength, quality, and purity.
- Our team conducts regular audits to proactively identify and correct non-conformances, preventing them from escalating into corrective actions.
- Perform periodic vendor and supplier audits and are responsible for approving or rejecting drug products manufactured, processed, packed, or held by another company.
- Coordinate FDA inspections or ISO audits.
- Review, investigate, and recommend actionable corrective actions for consumer complaints.
- Review, investigate, and report CDRH MDR and CDER Field Alert Reports (for NDAs and ANDAs), Biological Product Deviation Reports (for BLAs), ADR, EudraVigilance, and other adverse event requirements.
- Review, investigate, and assist with recalls and field corrections.
Above mentioned duties are some of the examples of what we can do for you. Again, we can perform all your essential quality functions without bias, influence, intimidation, or coercion from upper management. Outsourcing your quality unit functions can also help you build a strong rapport with regulators and certifying organisations, earning their respect and trust. Moreover, you can alleviate the stress on your in-house quality staff, who are already burdened with demanding roles.
Outsourcing The Quality Functions
Quality Unit by Former FDA Agents
Full-Time Contractor Quality Specialist
Although we are contractors, our experience and ability to handle daily and routine quality duties are exceptional. You can designate RAQA quality specialists with the responsibility and authority to approve or reject. Also, our quality specialists are just as committed and dedicated as your employees. They will report to our managers, and in turn, our manager will report to your executive chain of command. It aligns with the provisions of ISO 13854, 21 CFR 820, and 21 CFR 211, as well as the other CGMP organisations and personnel.
Grey Areas in Quality
When it comes to quality control, the circumstances are not always black and white. There are many grey areas, overlapping or even redundancy. Our quality specialists have encountered diverse situations and are experienced in handling them without rendering deficiencies or non-conformance events. Also, our quality specialists are trained to be transparent and efficiently communicate with your management, indistinguishable from in-house quality staff. After all, we work for you!
Outsource Your Quality Roles to RAQA Today!
Contact us today to discuss how our quality specialists can overcome your compliance and quality issues. There is no better time to partner with us for regulatory or quality.