FDA Compliance - Techlink

FDA GMP Quality System Implementation Consulting

GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. This includes requirements related to the methods used during production and the facilities and controls used in Medical Devices.

Although there are a number of them, all guidelines follow a few basic principles.

  • Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
  • Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
  • Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)
  • Operators are trained to carry out and document procedures.
  • Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the medical devices was as expected. Deviations are investigated and documented.
  • Controls of methods used for designing, purchasing, manufacturing, packaging, labeling and servicing medical devices.

TechLink International is an experienced FDA GMP consulting firm that has implemented several GMP and ISO quality systems for Medical Devices and IVD manufactures are trusted experts, including renowned former regulators who know how to institute proactive compliance, and have a strong track record of helping companies get out of regulatory crisis. If you already have ISO 13485:2003 certification, we can assist you in integrating FDA GMP into your existing QMS.

Your Trusted Source For Compliance.