How to write a Performance Qualification in 1 day.

What is a Performance Qualification

 

WHAT IS A PERFORMANCE QUALIFICATION PQ?

The Performance Qualifications is a collection of test cases used to verify that a system behaves as expected under simulated or real-world conditions demonstrating that the process or equipment is consistent over time with the user’s requirements and functional requirement specifications.

Establishing confidence through appropriate testing that the finished product or process produced by a specified process meets all release requirements for functionality and safety and that procedures are effective and reproducible.

The performance qualification testing must aim to challenge and fulfill the pre-established User Requirements Specification (or Functional Requirements Specification).

The PQ is the final step of qualifying a system, equipment, or process to establish scientific evidence that the process is reproducible and will reliably deliver quality products.  A manufacturer must successfully complete PQ before commencing the commercial distribution of the drug product.

The term “qualification” refers to activities undertaken to demonstrate that utilities and equipment are suitable for their intended use and perform properly.

During the (PQ), the process design is evaluated to determine if it is capable of a reliable and controlled commercial manufacture within specifications.

In this phase, the PQ aims to verify and document that the equipment is working with reproducible results within a specific production working range.

Instead of testing components and instruments one-by-one, PQ tests them all as a whole and overall process.

Depending on the size and complexity of the system, Performance Qualification PQ-E and PPQ can be combined in the same protocol document(s) with Installation Qualification or Operational Qualification.  But, the testing must be performed and executed in established chronological order: IQ first, OQ second, and PQ third.

3 Tips to prepare a Performance Qualification protocol:

1. Protocol Preparation and approval.

2. Protocol Execution and review.

3. Final Report Preparation and approval.

The PQ protocol must be prepared as per the FDA guideline “Process Validation: General Principles and Practices,” which officially defines the PROCESS VALIDATION into three (3) stage elements: httpss://www.fda.gov/media/71021/download

PERFORMANCE QUALIFICATION PROTOCOL PREPARATION

The PQ protocol may include, but, is not limited to the following sections, (as applicable)

  • Purpose
  • Scope
  • Background
  • Hardware Description
  • Infrastructure Identification
  • Associated Documents
  • Definitions and Acronyms

Process, Equipment Description, and Product Verification Instructions -Test Steps, as applicable.

  1. the studies or tests to use,
  2. the criteria appropriate to assess outcomes,
  3. the timing of qualification activities,
  4. the responsibilities of relevant departments and the quality unit, and
  5. the procedures for documenting and approving the qualification.

In addition, it includes the definition of performance qualification criteria and test procedures.

Selection of critical parameters, with predefined specifications.

Determination of the test intervals, e.g.,

(a) – Everyday.

(b) – Every time the system is used.

(c) – Before, between, and after a series of runs.

Define corrective actions on what to do if the system does not meet the established criteria.

That a system can handle multiple users without significant system lag

That when the system contains large quantities of data, queries are returned in a certain (short) period of time

That concurrent independent work-flows do not affect each other

That a laboratory test correctly identifies a known material

That a process was completed within defined system requirements

Manufacturing conditions such as equipment limits, operating parameters, and component inputs

A thorough list of the data that should be recorded or analyzed during tests, calibration, and validation

Tests to ensure consistent quality throughout the production

A sampling plan detailing the sampling methods used during and in between production batches

Analysis methodology for making data, scientific and risk-oriented decisions based on statistical data

Definitions for variability limits and contingency plans for handling non-conformance

  • Analysis of Test Results
  • Acceptance Criteria
  • Incident Reports Summary
  • Conclusions and Recommendations
  • Final Resolution and Release
  • Associated Reference Documents
  • Appendices
  • History of Change
  • Document Approval

What makes PQ successful?

Successful PQ must demonstrate that the process and equipment do as established in the Design Qualification documents, (URS and FRS) online under normal manufacturing operations.

Performance qualification (PQ) execution can be initiated after completed the execution and approval of the Installation Qualification and Operational Qualification activities.

The performance qualification must be executed by experienced and trained power users as the system is being tested and released.

Performance Qualification protocol(s) should be approved before protocol execution to comply with the prospective validation approach.

A copy of the unexecuted protocol should be kept in the validation package.

The unexecuted protocol should be approved at least by the protocol author, system owner, and quality assurance representative.

The final report of the executed protocol should be signed at least by the tester and reviewed by the system owner and quality assurance representative.

A Performance Qualification (PQ) is NOT a Process Validation (PV).

Some people confuse performance qualification with process validation.  For more information about process validation, click here.

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More details on specific FDA expectations for PQ can be found in the guidance document below. httpss://www.fda.gov/media/71021/download

Three (3) options to create a Performance Qualification Protocol

Option 1. You can create a great protocol, using a template.

You can download a free sample of a validation template in .pdf format. 

To see the complete list of the most popular validation templates, click here.

In addition, you can request a quotation to buy online a full validation template document in MS Word format that is completely editable, ready to fill, and adapt to your needs.

Option 2. We can bring you a formal training on how to create your own validation protocols using our template(s).

This option is recommended if you want to learn more about how to build a robust validation protocol. One of our expert(s) will provide online step-by-step training to your team (unlimited assistance) on how to build a reliable validation protocol using a template. You can improve your corporate validation procedures and policies incorporating our template sections.  It includes the template, an exam, and a training certificate for each assistant.  Request a quote now.

Option 3. We can create a customized performance qualification.

One of our expert(s) will create and prepare for you a customized validation protocol with the inputs and specific information of your company. It may include, online support in document creation, execution, or final reporting, Request a quote online.

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STATUTORY AND REGULATORY REQUIREMENTS

FOR PERFORMANCE QUALIFICATION

Validation for drugs (finished pharmaceuticals and components) is a legally enforceable requirement under section 501(a)(2)(B) of the Act (21 U.S.C. 351(a)(2)(B)), which states the following:

“… a drug (including a drug contained in a medicated feed) shall be deemed to be adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of the act as to the safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess.”

Process validation for drugs (finished pharmaceuticals and components) is a legally enforceable requirement under section 501(a)(2)(B) of the Act (21 U.S.C. 351(a)(2)(B)), which states the following:

FDA regulations describing current good manufacturing practice (CGMP) for finished pharmaceuticals are provided in 21 CFR parts 210 and 211.

The CGMP regulations require that manufacturing processes be designed and controlled to assure that in-process material and the finished product meet predetermined quality requirements and do so consistently and reliably.

Process validation is required, in both general and specific terms, by the CGMP regulations in parts 210 and 211. The foundation for process validation is provided in § 211.100(a), which states that “[t]here shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess…” (emphasis added). This regulation requires manufacturers to design a process, including operations and controls, which results in a product meeting these attributes.

Other CGMP regulations define the various aspects of validation. For example, § 211.110(a), Sampling and testing of in-process materials and drug products, requires that control procedures “. . . be established to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product” (emphasis added).

Under this regulation, even well-designed processes must include in-process control procedures to assure final product quality. In addition, the CGMP regulations regarding sampling set forth a number of requirements for validation:

Samples must represent the batch under analysis (§ 211.160(b)(3)); the sampling plan must result in statistical confidence (§ 211.165(c) and (d)); and the batch must meet its predetermined specifications (§ 211.165(a)).

In addition to sampling requirements, the CGMP regulations also provide norms for establishing in-process specifications as an aspect of process validation. Section 211.110(b) establishes two principles to follow when establishing in-process specifications. The first principle is that

“. . . in-process specifications for such characteristics [of in-process material and the drug product] shall be consistent with drug product final specifications . . . .”

Accordingly, in-process material should be controlled to assure that the final drug product will meet its quality requirements. The second principle in this regulation further requires that in-process specifications “. . . shall be derived from previous acceptable process average and process variability estimates where possible and determined by the application of suitable statistical procedures where appropriate.”

This requirement, in part, establishes the need for manufacturers to analyze process performance and control batch-to-batch variability.

The CGMP regulations also describe and define activities connected with process design, development, and maintenance. Section 211.180(e) requires that information and data about product quality and manufacturing experience be periodically reviewed to determine whether any changes to the established process are warranted. Ongoing feedback about product quality and process performance is an essential feature of process maintenance.

In addition, the CGMP regulations require that facilities in which drugs are manufactured be of suitable size, construction, and location to facilitate proper operations (§ 211.42). Equipment must be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use (§ 211.63). Automated, mechanical, and electronic equipment must be calibrated, inspected, or checked according to a written program designed to assure proper performance (§ 211.68).

References

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=225.1

https://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

httpss://www.fda.gov/media/94074/download

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=225.1

httpss://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

httpss://ispe.org/publications/guidance-documents/gamp-5

https://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

httpss://www.fda.gov/media/94074/download

https://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

httpss://www.fda.gov/media/94074/download

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=225.1

httpss://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

httpss://ispe.org/publications/guidance-documents/gamp-5

Related topics and resources:

Validation Plan, Installation Qualification, Operational Qualification, Performance Qualifications, Component Qualification, Traceability Matrix, Ppk, Control Charts, Cpk, User Requirements, Functional Requirement Specifications, GAMP5, risk assessment

Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!