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Performance Qualification - (PQ)

What is a Performance Qualification Protocol?

A Performance Qualification (PQ) is a testing protocol which provides documented evidence that the equipment's production runs at the predefined acceptable range of KPIV variables produces products which meet prefined acceptable specifications. The PQ qualification should be written in accordance with the Validation Plan.

A production run should typically run a minimum quantity and a minimum duration of time. Typically a shift of production. This could be an 8 hour shift or 12 hour shift. PQ production runs of each product configuration should typically be ran a minimum of 3 times. A production run should be run on all different shift of production.

The URS should be the basis for all validations for equipment, processes, and computer systems.

What is typically included in a Performance Qualification Protocol?

"Cover Page" - This page typically includes the Equipment Name, Specification Number, Company Name, Location, and Page Number and Number of Pages in the Document. The use of headers and footers in the document greatly help in this respect.

"Reviewers and Approvals" - A list or table should be provided to identify the associates who will author, review, and approve this document. It should include the name of the associate, their role / title, a place for a signature, and the date of approval.

"Table of Contents (TOC)" - The Table of Contents provides the reader a quick method for locating various sections within the document. When making changes to a document by adding / removing headers, the TOC can be updated by right clicking on the TOC and select update.

"Objective" - This section should describe the objective of the Performance Qualification.

"Scope" - This section should describe the scope for this Performance Qualification. The scope should typically identify the all the Equipment and Products involved in this qualification.

"Products" - This section should identify / list the Products to be manufactured on the equipment. It should include a Product Description and Finished Goods Number.

"Equipment List" - This section should identify / list the Equipment involved in this qualification. It should include a Equipment Name and Description, Equipment ID, Equipment Software, and Department.

"Responsibilities" - This section should describe the responsibilities of each of the associates function.

"Reference Documentation" - This section should identify all applicable reference documentation which was used to help develop the Performance Qualification. It should include Product Drawings, Component Drawings, Product Functional Requirements, Test Forms, Inspection Forms, Work Instructions, etc.

"General Qualification Strategy and Acceptance Criteria" - This section should describe the General PQ strategy and Acceptance Criteria of this equipment. This should include the equipment, materials, disposition of the product, any data analysis, and reports required.

"Deviation Handling" - This section should describe the deviation handling when performing the PQ qualification.

"PQ Validation Strategy and Acceptance Criteria" - This section should follow the PQ Validation Strategy as defined in the Validation Plan. This section should include PQ Runs Rational, Product Configurations, Number of Runs, Minimum Run Quantity, Minimum Run Duration, and Acceptance Criteria.

"Performance Qualification Activities" - This section should describe the PQ activities for this PQ qualification. This should include the Prerequisite Steps, Training, PQ Activities Defined, and PQ Runs to be executed.

"Revision History" - This section should identify all revisions to this qualification.

"Appendices" - This section should identify the appendices of this document. It should include a Training Form, Calibration Documentation, Production Runs Product Configurations, and Production Runs Results.

How does our Service help generate the Performance Qualification protocol?

Our service can automatically fill out most of the sections in your PQ. The requirements files (Excel) contain the tag replacement information for all documents. Below are the sections our service automatically fills in the PQ qualification.

"Project Name" - Our service will automatically fill in the Project Name in the PQ qualification where a tag {{ProjName}} is found.

"Equipment Name" - Our service will automatically fill in the Equipment Name in the PQ qualification where a tag {{EquipName}} is found.

"Specification Numbers" - Our service will automatically fill in the specification numbers in the PQ qualification where a tag {{PQ_Spec}} is found.

"Reviewers and Approvers" - Our service will automatically fill in the Reviewers and Approvers table with the Role, Name, and Title of the associates.

Performance Qualification Approvers

"Scope" - Our service will automatically fill in the Scope in the PQ qualification where a tag {{@ScopeXml}} is found.

"Products" - Our service will automatically fill in the Products table with the Product Description and Finished Goods Number.

Performance Qualification Products

"Equipment List" - Our service will automatically fill in the Equipment table with the Equipment Name and Description, Equipment ID, Equipment Software, Equipment Department.

Performance Qualification Equipment Info

"Reference Documents" - Our service will automatically fill in the Reference Documents table with the Document Number, Revision, and Document Title.

Performance Qualification Documentation