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cGMP – Design and Development Master Validation Plan (10)

July 15th, 2019 Posted by Requirements Management Tool, Test Management, Validation and Verification 0 thoughts on “cGMP – Design and Development Master Validation Plan (10)”

People in the medical device industry are often wary of the term validation even though they shouldn’t. Validation is using objective evidence and experiment to ensure that a set of requirements are met when testing for product or service usage. Furthermore, as it pertains to device validation. The objective is to match the specifications with user needs and application. Therefore, validation is proof that using a specific process to manufacture a device will meet both device requirement and user demands.

Validation is the building block for verifying the quality of a product. As a result, the product that is tested during validation must represent the final product. According to ISO 13485, companies must keep a record of the product they use during validation.

Validation MVP

In the same way that the design control process starts with a plan, validation must take the same approach.  The plan is often extensive, covering several areas earning the name Validation Master Plan (VMP) or Master Validation Plan (MVP). It is best to always start the validation plan early in the design process. The plan should be able to pinpoint what will help satisfy the criteria like;

  • Methodologies
  • Performance properties
  • Validation activities

Likewise, there should be a review of the validation plan to avoid risk and deficiencies.

“The First Article”

The first article is the common name given to the first set of products. They are either serialized batch or initial batch (Validation batch). In some cases, validation reports help to document the properties of the first articles. Also, there could be a separate first article report. Forgetting to include labeling and packaging as part of the validation process is a common oversight.

It is crucial that companies include packing in their validation plan. Its effect of product performance is enormous and difficult to measure.  Some packaging can give off electrostatic charge or cause the material to leach into a sterile product. Therefore, testing the packaging can help prevent such occurrences. Similarly, the validation plan should include labels. Environmental conditions can cause labels to fail, leaving the product bare and unbranded.

Inclusion of clinal trials in the product validation is optional and depends on the type of product. Nevertheless, there should be some form of clinal evaluation just in case. Also, validation should account for the worst possible scenarios using simulations that mimic the conditions that the product will face. Some possible simulations can test for the following;

  • Vibration and shock
  • Temperature
  • Humidity
  • Other tests will account for either transportation or storage of the product.

Finally, validation should take into account the following customers/users;

  • Operators
  • Patients
  • Caregivers (nurses/doctors)
  • Other relevant parties

MVP and VMP

Orcanos Master Validation Plan

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