Validations

Validations

 

Validations and Qualifications

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Validation is required for new products, processes, or equipment. Existing processes or equipment with significant changes require a re-validation.

Change Control procedures control and assess process changes to ensure all qualifications, validations, and updates to procedures occur as appropriate.

Validation Master Plan (VMP)

The validation master plan (VMP) outlines the validation process for projects or departments. This plan may included the validation methodology, types of qualifications, what is to be included in each validation or qualification, who is responsible for the processes, what SOPs are used, and the schedule or timeline for validations. This master plan outlines the approval and authorization process of validation protocols in addition to tracking the validations and their stage of progress.

 

Validations

Prospective Validation

Concurrent Validation

Retrospective Validation

Revalidation

 

Types of Validation (Validation Processes)

    • Facilities

 

    • Utilities

Water Systems Validation

 

    • Product

 

    • Process Validation

Process Validation protocols outline the construction of validation protocols such as process performance qualifications (PPQ)

 

      • Process Design/Technology Transfer

Critical to Quality Attribute (CQA) and Critical Process Parameters (CPPs)

 

      • Process Performance Qualification (PPQ)

 

      • Continued Process Verification

 

    • Equipment Validation

Prior to equipment purchase, information should be compiled regarding the requirements and variables involved with the process or equipment. With large or customized equipment, clients may request initial qualification from the equipment manufacturer. This initial, offsite qualification should not be used in lieu of on site qualification.

General:

What are the boundaries of the equipment or system the equipment is placed in? (what processes or equipment feed into or out of it?)

Location:

Where will the equipment be placed?
How much room is available?
What are the environmental requirements? (Temp, air changes/ventilation, humidity)
What utilities are needed? (Water, pressurized air, electricity)

Documentation

What certifications, manuals, drawings, or figures are provided with the equipment or are needed for installation?
(This may include electrical diagrams, location maps, design documentation, spare parts lists, user manuals, calibration certificates, etc.)

 

 

Sterility

Cleaning Validation (compounding/manufacturing)

Solution Uniformity

Cleaning Validation (Cleaning instructions/Sterility)

Analytical Method Validation

Computer System Validation