Good Manufacturing Practice is an integral part of your quality system. It creates the standards for your production process in everything from documentation to distribution. A concrete set of GMP procedures gives you a clear and complete blueprint of your commitment to quality for regulators and investors alike. From creation to contingency plans, every aspect of your manufacturing process will be ready for implementation with the highest standard.


Performing self-inspections is critical to ensuring that quality systems remain effective and operating in a state of compliance. Objective self-inspections are key to providing senior management and the Board of public companies assurance that compliance issues, concerns, or gaps are pro-actively identified in a timely manner and then corrected or mitigated to reduce compliance risks during actual regulatory inspections. Third party consulting firms such as JYA provide the "objectivity" that is needed to properly ensure that the benefit of having "outside eyes" evaluate existing quality systems is realized on a routine basis particularly when it comes to auditing Quality Assurance and/or Regulatory Compliance Departments.

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A well-documented and thorough GMP training program is a basic expectation of FDA inspectors of any company involved in the manufacture of therapeutic products and medical devices. Manufacturing organizations are expected to have standard operating procedures (SOPs) defining these programs. Current Good Manufacturing Practices require that training be an ongoing process.

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