Medical Device Manufacturing Process Validation

The guideline on "General Principals of Process Validation" was issued in May 1987, and since then, medical device companies have struggled with the principals of process validation. Successfully validating a process may reduce the dependence upon intensive in process and finished product testing. Due to the complexity of today's medical products, routine end product testing alone is often not sufficient to assure product quality for several reasons. Some end product tests have limited sensitivity. In some cases, destructive testing is required to show that the manufacturing process is adequate. In certain situations end product testing does not reveal variations that may occur in the product, which may impact safety and effectiveness.

21 Code of Federal Regulations (CFR) Part 820.75 states that:

• Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented.
  • Each manufacturer shall ensure that validated processes are performed by qualified individual(s).
  • For validated processes, the monitoring and control methods and data, the date performed, and, where appropriate, the individual(s) performing the process or the major equipment used shall be documented.
• Each manufacturer shall establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met.
• When changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate. These activities shall be documented.

Validation Services Provided:

•   Medical Device Manufacturing Process Validation

•   Drug Manufacturing (Oral/liquid dosage) Process Validation

•   Test Method Validation

•   Cleaning Validation

•   Supplier Quality Validation

•   Electrical System Validation

•   Utilities/HVAC Validation

•   Computer System Validation (CSV)

•   CAPA Owners/ Investigators

•   Quality Assurance

•   Thermal Validation

•   Packaging Validation

•   Passivation process Validation

•   Sterilization process Validation