Skip to content

Our mission is to enable healthcare companies to operate more effectively through international professional outsourced solutions. We empower healthcare companies to operate more effectively and successfully by providing professional, international outsourced services they can trust.

Our clients put their reputations in our hands and that is a responsibility we take incredibly seriously. We make quality our highest priority. As industry leaders, it is built into everything we do, for every client, and every member of our team is committed to delivering impeccable standards and results.

We guarantee quality by:

  • Complying with or exceeding all regulatory requirements
  • Implementing and supporting quality systems which meet or exceed our clients’ needs
  • Providing ongoing quality training for our professional associates
  • Continuously improving our operational processes and performance

Supply Chain and Sourcing

Sharp has a strong program for Supply Chain Management starting with the evaluation of each supplier prior to engagement.  We have established several reliable sources of packaging suppliers, and most have been in our supply chain for 5 years or longer.  A Certified Supplier program was initiated in 2019 to recognize those suppliers who continue to provide Sharp with excellent products for use in our operations. Each supplier is required to meet specific criteria established by Sharp to achieve this status.  This process including on-site audit with acceptable results, review of manufacturing and batch record process review with no significant issue, no quality issue identified upon Sharp site inspection for a minimum number of batches.

Starting materials are checked by trained quality control personnel at incoming against specifications to ensure the quality of the starting materials and any deficient lots are quarantined.

Product Testing

Products packaged by Sharp are subject to in-process and release testing, using the test methods and acceptance criteria are agreed with the client. Testing on packaged products is performed by trained personnel and the results are documented in the batch record and are reviewed by the quality department prior to release.

Our quality credentials

  • Current Good Manufacturing Practice (CGMP) facilities
  • US Food and Drug Administration (FDA) registered and inspected
  • US Drug Enforcement Agency (DEA) registered and inspected
  • European Medicines Agency (EMA) approved
  • Brazilian National Health Surveillance Agency (ANVISA) approved
  • UK Medicines and Healthcare Products Regulatory Agency (MHRA) approved

Related Resources

1

Quality

Partnership

Ingenuity

Expertise

Energy

It’s not just what we do, it’s the way that we do it.

Sharp has partnered with @BerkshireSM to provide clients with a seamless, end-to-end #pharmaceutical manufacturing, packaging & distribution solution.

Learn more about how our combined expertise can benefit your project: https://lnkd.in/eW4QmJm

Are you registered for tomorrow's webinar?

Don’t miss your opportunity to hear from our experts as they discuss both the internal & external forces impacting the scaling of #clinical & #commercial drugs and how to avoid these pitfalls.

Register here: https://lnkd.in/eHFmUh8

Sharp has appointed Ria Rhemrev-Boom as its new lead EU Qualified Person (QP) for market release services.

https://www.sharpservices.com/resources/news/sharp-appoints-eu-qualified-person/

#QualifiedPerson #MarketRelease #QualityManagement