Commissioning and Qualification – An Overview Schedule a

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Brad Henry

Vice President, Indiana Division

BACK Director - Brad has over 20 years
of experience managing and
executing CQV projects for the
pharmaceutical and medical device
Commissioning and Qualification – An Overview Categories
industries. He has extensive
Buildings and equipment used in the manufacture, processing, packaging, holding or storage of drug BLOG experience in dry products,
product are subject to the regulations set forth by the FDA in 21 CFR Part 211. These regulations BUILDING COMMISSIONING parenteral, facilities and utilities,
are considered the minimum current good manufacturing practices (cGMPs), for the manufacture of CAV
and in-vitro diagnostics.
human and animal drug products. Commissioning and qualification of these buildings and CONSULTING SCHEDULE WITH BRAD HENRY
equipment is essential for ensuring compliance to these regulations and confirming that the drugs
CQV
manufactured within them are fit for their intended use.
CSA
As described by USFDA (2011, p. 10): During the process qualification (PQ) stage of process CSV
validation, the process design is evaluated to determine if it is capable of reproducible commercial MEDICAL DEVICE
manufacture. This stage has two elements: (1) design of the facility and qualification of the
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equipment and utilities and (2) process performance qualification (PPQ).
SMOKE STUDY
To meet the goals identified by USFDA above, there are a number of accepted methods and/or TEMPERATURE MAPPING
practices that can be used. This includes consensus guides such as ASTM E2500-13, Standard UNCATEGORIZED John Underwood
Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical
manufacturing systems and Equipment, industry guidance such as ISPE’s Baseline Guide Volume 5: Keep in touch. Sign up to be informed of the latest
Vice President, Michigan Division
Commissioning & Qualification, among others. Some companies have merged elements of multiple Director - With over 20 years of
new resources from Performance Validation.
approaches into a unique company solution. Provided the solution meets the requirements of the industry experience, John has been
First Name * fortunate enough to experience all
cGMPs any solution should be deemed adequate. The graphic below provides one possible solution
to meet the intent of the 2011 process validation guidance. levels at PV and has provided
services to the pharmaceutical and
Planning medical device manufacturing
Last Name * industries. He has extensive
Prior to starting commissioning activities, a plan should be developed. Depending on the organization
experience in dry products,
the plan may be referred to as a Commissioning Plan, Commissioning and Qualification Master Plan
parenteral, facilities and utilities,
(CQMP), or Validation Master Plan (VMP). The plan should define and provide an overview of the
API, and computer systems.
system, facilities, and equipment to be commissioned and/or qualified. The plan should include the
Email *
scope and strategy of activities, an overview of deliverables to be completed, and the roles and SCHEDULE WITH JOHN
responsibilities of the persons involved. Planning is addressed in ISPE Baseline Guide Volume 5: UNDERWOOD
Commissioning & Qualification, FDA Guidance for Industry: Process Validation – General Principles
and Practices, and ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical
Select which resources you would like to be
Ingredients.
notified about.
Quality Risk Management Blog
Case Studies
Quality risk management tools are utilized as a means to determine which aspects of the process will
have the largest effect on product quality (USFDA, 2011). Tools such as impact assessments are Technical Discussions
conducted on systems to evaluate their impact on product quality and to determine which system
components are to be deemed critical (International Society of Pharmaceutical Engineering [ISPE},
2007). Other risk management tools help to identify the critical quality parameters such as Fishbone SUBMIT
diagrams, Failure Mode Effects Analysis (FMEA), and Design of Experiments (DoE) (International
Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for
Human Use [ICH], 2005, 2009). Utilizing quality risk management tools may also help narrow the
scope of qualification to what’s most important, e.g. Critical Quality Attributes (CQAs) and Critical
Process Parameters CPPs thus reducing cost (ASTM International, 2013; International Conference
on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use
[ICH], 2009).

Commissioning

Commissioning is a systematic approach to the start-up and turnover of facilities, systems, and
equipment to end-users and ensuring that user requirements and design specifications are met
(International Society of Pharmaceutical Engineering [ISPE}, 2007). Activities within this phase may
include design reviews, factory acceptance testing, installation verification, and functional testing.
Summary reports are generated at the conclusion of commissioning activities and include an
overview of the results and any deviations encountered during testing. Commissioning, if well
documented, may be leveraged to reduce or eliminate qualification testing.

Qualification

As defined in the FDA Process Validation Guidance, qualification refers to the activities undertaken
to demonstrate that utilities and equipment are suitable for their intended use and perform properly.
As discussed previously there are multiple approaches that demonstrate suitability for intended use.

Under an ISPE Baseline Guide 5 approach, systems and equipment determined to have a
direct impact on product quality are typically qualified using Installation and Operational
Qualifications. While systems with an indirect impact on product quality may only be
commissioned.
Under an ASTM E2500 approach, testing typically considered as part of IQ/OQ is referred to
as verification. ASTM E2500 emphasizes utilizing a science-and-risk-based approach in order
to focus the verification activities on critical aspects of the system.

Commissioning activities, if performed to cGMP standards may be leveraged during the Qualification
phase as they verified the system is suitable for its intended use and demonstrated proper
functionality.

Acceptance

Multi-functional teams, which should include the Quality Unit for Direct Impact/Quality Critical
systems, provide final approval of qualification or testing documentation and deem the system or
equipment fit for its intended use. At this stage, a declarative statement is made on the disposition of
the system or equipment and the release for operational use. Summary reports are generated at the
conclusion of qualification and include an overview of the results and any deviations encountered
during testing.

Systems that have a direct impact to product quality are accepted by the organizations quality
unit among other SMEs (International Society of Pharmaceutical Engineering [ISPE}, 2007).
Systems with critical aspects are accepted by the organizations quality unit among other SMEs
(ASTM International, 2013)

Process Performance Qualification

As described in (USFDA, 2011, p. 11): Process Performance Qualification (PPQ) combines the
actual facility, utilities, equipment (each now qualified), and the trained personnel with the
commercial manufacturing process, control procedures, and components to produce commercial
batches A successful PPQ will confirm the process design and demonstrate that the commercial
manufacturing process performs as expected . PPQ is documented through an approved testing
protocol that specifies the manufacturing conditions, controls, testing, and expected outcomes .

The PPQ lots should be manufactured under normal conditions by the personnel routinely expected
to perform each step of each unit operation in the process. Normal operating conditions should
include the utility systems (e.g., air handling and water purification), material, personnel,
environment, and manufacturing procedures. PPQ must be successfully completed before product
can be distributed commercially (USFDA, 2011, p. 13). During PPQ, process data is collected and
evaluated to ensure the manufacturing process performs as expected.

On completion of testing, a summary report is created that includes analysis of data collected, a
discussion of any manufacturing nonconformance, description of corrective actions, any changes to
existing procedures and controls, and a conclusion stating whether or not the process meets
established acceptance criteria.

Acceptance of this report by a multi-functional team including Engineering, Area Manager, Quality
Assurance, and Quality Control releases lots for distribution, provides approval of the process, and
deems the process ready for Stage 3 – Continued Process Verification. Under stage 3, the
organization is responsible to establish one or more systems that will monitor the manufacturing
process to detect unplanned departures from the process. As defined by USFDA (2011, p. 14):

An ongoing program to collect and analyze product and process data that relate to product quality
must be established (§ 211.180(e)). The data collected should include relevant process trends and
quality of incoming materials or components, in-process material, and finished products. The data
should be statistically trended and reviewed by trained personnel. The information collected should
verify that the quality attributes are being appropriately controlled throughout the process.

About Performance Validation

Performance Validation has assisted large and small pharmaceutical manufactures in providing turn-
key or staff augmentation support for commissioning, qualification, and validation projects. We have
successfully worked with companies that have implemented an ISPE Baseline Guide methodology,
an ASTM E2500 methodology, and various combinations to achieve a compliant solution. For
services offered please see the Commissioning & Qualification page of our website. For
information on projects that we have successfully completed please see the Projects
Summaries page of our website. Our goal is to provide our customers with peace of mind
concerning their commissioning, qualification, and validation projects.

Please use our contact us page if you have a question on Commissioning, Qualification, and
Validation or would like further information on Performance Validation’s capabilities.

References:

ASTM International. (2013). E2500-13: Standard guide for specification, design, and verification of
pharmaceutical and biopharmaceutical manufacturing systems and equipment. West
Conshohocken, PA: ASTM International.

International Conference on Harmonization of Technical Requirements for Registration of

Pharmaceuticals for Human Use [ICH]. (2005). Quality risk management. Retrieved
from https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf

International Conference on Harmonization of Technical Requirements for Registration of

Pharmaceuticals for Human Use [ICH]. (2009). Pharmaceutial development. Retrieved
from https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf

International Society of Pharmaceutical Engineering [ISPE}. (2007). Baseline guide: Volume 5

commissioning and qualification (Vol. 5). Tampa, FL: ISPE.

USFDA. (2011). Guidance for Industry. Process Validation: General Principles and Practices.
Rockville, MD, USA: Government Printing Office.

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