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Medical Device Process Validation - Overview: Part 1

What is Medical Device Process Validation?

This is a frequently encountered question in the medical device industry and one that I hope to provide a brief overview of.

The post has been split it into two Parts. In Part 1, we will:

  • Provide some definitions

  • Distinguish between verification and process validation

  • Cover Installation Qualification (IQ)

  • Briefly mention process characterization (which is so important it will get its own separate post later)

  • Begin our discussion of Operational Qualification (OQ)


The US FDA, in Title 21, U.S. Code of Federal Regulations (CFR) – Part 820, defines medical device process validation as:

Sec. 820.3(z)(1) Process Validation: establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

To establish means to define, document (in writing) and implement [Sec. 820.3(k)].

“If you didn’t document it, you didn’t do it!”

– Industry adage

Difference Between Verification and Validation: When to Validate the Process

Paragraph 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…”

Validation is required for processes that can’t be fully verified or where full verification is destructive, e.g.:

  • Sterilization

  • Packaging sealing

  • Cleaning, Etc.

Other processes may be fully verified or validated.

Basic Steps:

Installation Qualification (IQ)

Installation qualification (IQ): establishing by objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the manufacturer’s approved specification and that the recommendations of the supplier of the equipment are suitably considered*.

* Global Harmonization Task Force, Quality Management Systems – Process Validation Guidance (2004).

Contents of the IQ protocol may include:

  • Equipment Identification

  • Utility verification

  • Vendor documents

  • Calibration / Maintenance

  • Consumables / Spare parts

  • Safety features / alarms

  • Functional verification

  • Equipment parameters, Etc.

Process Characterization

Such an essential part of pre-OQ/PQ activities the plan is to devote another post to it.

Operational qualification (OQ)

Operational qualification (OQ): establishing by objective evidence process control limits and action levels which result in product that meets all predetermined requirements*.

* Global Harmonization Task Force, Quality Management Systems – Process Validation Guidance (2004).

Most processes have parameters that can be adjusted to compensate for variation encountered during manufacturing. Also, most processes will manufacture a product family with more than one part number (e.g. different sizes, dimensions, colors, etc.)

In the OQ, these process parameters and part numbers are challenged to make sure they will result in products meeting all requirements.

More in the next post...




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