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Equipment Qualification Guidelines

Equipment qualification involves validating equipment used in pharmaceutical manufacturing through a series of qualification phases to ensure the equipment functions properly and produces products meeting specifications. The validation process begins with creating a user requirements specification document detailing the equipment's intended use and functions. This document forms the basis for design qualification, installation qualification, operational qualification, and performance qualification phases which work to establish the equipment is built, installed, and operates as intended to consistently manufacture quality products.

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993 views3 pages

Equipment Qualification Guidelines

Equipment qualification involves validating equipment used in pharmaceutical manufacturing through a series of qualification phases to ensure the equipment functions properly and produces products meeting specifications. The validation process begins with creating a user requirements specification document detailing the equipment's intended use and functions. This document forms the basis for design qualification, installation qualification, operational qualification, and performance qualification phases which work to establish the equipment is built, installed, and operates as intended to consistently manufacture quality products.

Uploaded by

RainMan75
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
  • Introduction to Equipment Qualification: Provides an overview of validation in the context of equipment qualification, including aspects such as design qualification and performance qualification.

Equipment Qualification

Contents

 Validation

 User Requirement Specification. (URS)

 Phase of validation

 Design qualification (DQ)

 Installation Qualification (IQ)

 Operation Qualification (OQ)

 Performance Qualification (PQ)

 Maintenance Qualification (MQ)

 Component Qualification (CQ)

o Instrument Re-Qualification

What is Validation
According to the Food and Drug Administration (FDA), the goal of validation is to:
“Establish documented evidence which provides a high degree of assurance that a
specific process will consistently produce a product meeting its predetermined
specifications and quality attributes.”
 It is a requirement for Good Manufacturing Practices and other regulatory
requirements.

What does this mean?


A quantitative approach is needed to prove the quality, functionality, and
performance of a pharmaceutical/biotechnological manufacturing process.

 This approach will be applied to individual pieces of equipment as well as the


manufacturing process as a whole.

 Guidelines for validation are set by the FDA, but the specifications of validation
are determined by the pharmaceutical/biotech company.

User Requirements Specification (URS):


User Requirements Specification (URS), is the most critical of documents and yet, the
most often bungled. Whether the system is purely mechanical, or a mix of electro-
mechanical, or solely a software program, the successful compilation and execution of
the Installation Qualification (IQ) (for installation), Operational Qualification (OQ) (for
functionality), and the Performance / Product Qualification (PQ) (for operability), is
dependent on a User Requirements Specification (URS) containing clear, concise and
testable requirements.

Once the end user requirements specification is documented, agreed and approved they
form the basic URS Level-1 document.
The engineers (or vendor) can then commence the preliminary design to establish exactly
what functions are required for each of
the items specified in the user requirements specification, the end user has listed. Once
this functionality is documented and
approved it forms URS Level-2 document. This is the final level of the URS unless
software is used.
If software is to be used, the URS Level-2 document, is passed to the code writers. As the
code is written, lines, or groups of lines,
of code must be attributed to the individual functions that necessitate their presence. The
completion of this task results in
the completion of the URS Level-3 document

Developing the URS to this level is unique in most industries, but is, standard practice in
strictly regulated industries, as it is a
major building block in the creation of quality software. The URS Level-3 document,
contains all the traceability which is deemed
mandatory for software assessed to be critical to product quality, in the pharmaceutical
regulated industries.
The URS can contain a large number of requirements and should therefore be structured
in a way that will permit easy access to information.
The requirement specification must be formally reviewed and approved by the
pharmaceutical manufacturer.
The following guidelines should be followed during the production of the URS :
1. Each requirement statement to be uniquely referenced, and no longer than 250
words.

2. Requirement statements should not be duplicated or contradicted.

3. The URS should express requirements and not design solutions.

4. Each requirement should be testable.

5. The URS must be understood by both user and supplier, ambiguity and jargon
should be avoided.

6. The use of diagrams is often useful.

7. The scope for readers to make assumptions or misinterpret

8. Should be minimized.

9. Wherever possible, the URS should distinguish between mandatory/regulatory


requirements and desirable features.

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