How do I validate a product

BlogQM Systems & ISO 13485Process Validation: Definition & Example ~ What you should definitely pay attention to

Process validation: definition & example ~ What you should definitely pay attention to

Under Process validation one understands the proof that a process fulfills the requirements for its process results.

Learn when you have to validate which processes (in the software context) and how you can easily do it. Also find out what process validation has to do with PQ, IQ and OQ.

Process validation: what exactly is it?

a) Definition of the term "validation"

ISO 9000: 2015 defines validation as follows:

"Confirmation by providing objective evidence that the requirements for a specific intended use or application have been met."

The standard notes that the objective evidence required for validation is the result of a test or some other form of determination such as alternative calculations.

b) Definition of the term "process"

When defining the term process, ISO 13485 again falls back on ISO 9000: 2015. This understands by a process:

"A set of related or mutually influencing activities that uses input to achieve an intended result."

Examples of processes are

  • Development process
  • Sterilization process
  • Production process
  • Hiring process
  • Sales process

For the rest, we should also state that processes not only have inputs ("inputs") and outputs ("results"), but also require resources such as people and machines (including software / IT).

c) process validation

If you put both definitions together, the result is that one Process validation Confirmation through the provision of objective evidence that a process delivers the intended process results.

For example, in a development process, one would ensure that the development result meets the requirements (“design input”). A sterilization process would ensure that the items to be sterilized are really sterile.

The FDA defines the term directly:


"Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications."

Practical tips for validating processes

a) Only validate relevant parameters

Products usually have several properties that manufacturers must ensure. The decision as to whether a validation is necessary does not have to be made for each product / process, but for each property (parameter). A very simplified example:

A syringe must be sterile and of a certain length. You can easily verify the "Length" parameter. So you wouldn't have to validate the process to make sure it produces syringes of the correct length - unless you don't want to do the 100% correct length check.

On the other hand, you cannot guarantee the “sterility” parameter with a “final test” because that would be a destructive test. A process validation is necessary here.

b) validate verification process?

If you are performing a 100% automated length check, this automated check is also a process or process step that you have to validate. If this process or process step contains software or computer systems, you must validate them. A describes how you can proceed Article on Computer System Validation CSV.

c) Verify instead of validating

In some cases, a final test is impossible, but a test of the product parameter is already an intermediate step. For example, if you can verify the correct assembly of a component, which is not possible in the final product, the process would not necessarily need to be validated to determine whether the component assembly is correct.

Product parametersProcess step 1Process step 2End testValidation necessary?
Parameter 1No test necessaryNo test necessarytest completedNo
Parameter 2No test necessarytest completedNo test possibleNo
Parameter 3No test possibleNo test possibleNo test possibleNo test possibleYes

d) Process validation and PQ, IQ and OQ

Companies (especially in the pharmaceutical sector) often differentiate between the following phases of process validation:

  • IQ: This first test at the customer's during installation is intended to ensure that the device was delivered, set up and installed in accordance with the specification, that it meets the requirements of the user and that the documentation is available. The basics for calibration, maintenance and cleaning are set here. You should have a look at the instructions :-).
  • OQ: The most extensive test should check whether the device is working according to the specification, especially at the specification limits, in order to know what is the worst case scenario.
  • PQ is then only the proof that the process also runs under normal conditions. The aim of this test is, among other things, the measurement accuracy (including calibration and adjustment). It's also about long-term stability. In the pharmaceutical world, you try at least 3 batches. A P diagram shows what influencing factors are such as environmental conditions, work steps, process parameters, material properties. This is where sampling plans come in.

Regulatory requirements for process validation

a) Requirements of ISO 13485

Like ISO 13485: 2010, ISO 13485: 2016 requires process validation under the following circumstances:

  1. The process is a production or service process
  2. The results of this process may or may not be verified, e.g. through a measurement.
  3. The deficits in these process results would only become apparent when the product is used or after the service has been used.

If these conditions are met, process validation is mandatory. To do this, the company must establish procedures including

  • Criteria for evaluating the process
  • Qualification of the staff
  • Use of methods and procedures
  • Documentation / records
  • Re-validation
  • Approval of changes to processes.

If software is used as part of these processes, this software must be validated.

b) Further national and international relevant regulations

The now defunct Global Harmonization Task Force GHTF has published a document GHTF SG 3 NB 99: 10: 2004 on process validation, which is meanwhile "administered" by the IMDRF.

The central office of the federal states ZLG has also published a document with the number ZLG 3.9 B 18 and the title "Validation of processes in production and service provision (including software)".

You should also keep an eye on Good Manufacturing Practices and the GAMP5 Guide.

c) FDA requirements

In the Quality System Regulations, specifically in 21 CFR 820.75, the FDA describes the requirements for process validation:

It also only requires this if the process results cannot be verified. These validation activities must include:

  • The activities carried out must be documented with the date and signature.
  • Procedures must be established to monitor the process parameters.
  • Only qualified persons are allowed to validate the processes.
  • The methods and data for the control and monitoring of the processes, the date of implementation and the persons performing it, as well as the relevant equipment must be documented.
  • In the event of changes, the manufacturer must assess whether a re-validation is necessary and then carry this out if necessary.

The FDA states the requirements for the validation of software in the "Guidance Document Software Validation".

Categories: QM systems & ISO 13485

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