FDA, in its guidance, Process Validation: General Principles and Practices, officially defines the PQ certification stage into two elements:

Facility design and qualification of equipment and services

Device performance qualification during the production process PPQ (Process Performance Qualification)

In the second step, the FDA states in its guidance that CGMP-compliant procedures must be followed and that completing step 2 is necessary before commercial distribution.

FDA guidance recommends including the following elements as part of PQ and PPQ protocols:

1. Production conditions such as equipment limitations, performance parameters, and input of parts
2. A complete list of data to be recorded or analyzed during testing, calibration, and validation
3. Tests to ensure consistent quality during production
4. A sampling plan that details the sampling methods used during and between batches of production
5. Analysis method to make data, scientific and risk-based decisions based on statistical data
6. Definitions for diversity limits and possible plans to address non-compliance
7. Approval of the PPQ protocol by the relevant departments – i.e., Quality Control Unit.

• Instead of filling a traditional full-time role, many life sciences organizations partner with sourcing firms that can recruit and deploy qualified professionals through a flexible staffing or staff augmentation model.

This type of classification has many advantages for quality departments and hiring managers, such as:

1. 1. Providing access to qualified personnel in an increasingly competitive workplace
   2. Freeing up time and attention in internal teams
   3. Reducing the costs of hiring, screening, and attendance of employees

• Unlike traditional full-time hires, a flexible staffing model with a large, global staff of qualified personnel allows you to adapt to cyclical or project-based demands and build new skills and experiences into the team.

Examples of performance qualifications

• For example, a performance qualification may indicate the following:

1. 1. That a system can handle multiple users without much system latency
   2. When the system contains large amounts of data, searches are returned in a certain (short) time interval.
   3. That independent workflows do not affect each other at the same time.
   4. That a laboratory test correctly identifies a known substance
   5. That a process is completed within the required system scope

• Each qualification stage should include instruction, expected, and actual results. Any discrepancy between the expected and actual results should be tracked as a deviation. Deviations must be resolved before validation can be completed.
• In short, performance qualification is the last and longest stage in the entire qualification process. PQ certification is documented evidence provided in the qualification that a system works reliably and consistently and is produced within specified parameters. It also talks about ‘performance competence’, which is divided into the following stages:
• Completion of OQ
• Create a PQ plan
• Approval of the PQ plan
• Check the calibration certificates.
• Do the PQ
• Create a PQ report
• Approval of PQ report
• Process validation.