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HOW TO DEVELOP AND DOCUMENT A CONTAMINATION

CONTROL STRATEGY

 (https://www.golighthouse.com/en/blog/risk-golighthouse.com/en/blog/industry-1-pharma-4/)

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 Table of Contents

1. GMP Annex 1 And Your CCS

2. Developing Your CCS

2.1. Define

2.2. Position
2.3. Establish

2.4. What Should You Include In Your CCS?

3. Documenting Your CCS

4. Are You Staying Up To Date?

Your Contamination Control Strategy (CCS) is the foundation of your cleanroom. This is where
you plan how to avoid contamination, what to do in the event there is a breach, and prove that
you have done your homework.
For too many years, a CCS has been an afterthought. The cleanroom was developed, protocols
put in place, and segmentation decided on before the CCS was haphazardly put together
based on these separate establishments. Now, though, regulatory authorities are putting an
emphasis on CCS – and, more importantly, developing your cleanroom around the CCS instead
of the other way around.

GMP Annex 1 And Your CCS

For example, the European Union (EU) Good Manufacturing Practice (GMP) for Medicinal
Products for Human and Veterinary Use – Annex 1, commonly referred to as GMP Annex 1
(https://www.golighthouse.com/en/blog/gmp-annex-1-2022-update-breakdown-part-1-629/),
published an update in 2022 that shows the shifting emphasis to incorporating CCS into the
design and function of your cleanroom.

While Annex 1 is technically only guidelines for pharmaceutical organizations, the standards are
applicable to most all cleanrooms and are worth familiarizing yourself with. Its infrastructural
approach to Quality Risk Management (QRM) through a detailed and extensive Contamination
Control Strategy (CCS) highlights the importance of documentation and personnel knowledge.
While it focuses on getting humans out of the cleanroom wherever possible and automation to
avoid contamination, it still emphasizes a reliance on and documentation of their knowledge
and reasoning behind their choices, as well as more training and more detailed gowning
procedures.

Developing Your CCS

Ideally, your CCS would be created or revised when you are making major adjustments to your
cleanroom, or developing a new one. This would allow for the ultimate integration of the CCS
into the development and infrastructure of the cleanroom. If you are part of the population who
only has until August 2023 to come into compliance with the GMP Annex 1 update, this might
be a season of transition. For many, though, this is not a feasible reality and you will not be
massively changing your cleanroom and, instead, building a CCS around an existing cleanroom
and set of protocols.

According to Siegfried Schmitt (https://www.biopharminternational.com/view/creating-a-

contamination-control-strategy), vice president, Technical at Parexel, when developing your CCS
you should take 3 steps: define, position, and establish.

Define
You can start your CCS by defining its scope. This scope should include sterile products and/or
any products or ingredients that require bioburden control. You should also identify potential
contaminants that would affect efficacy, sterility, and quality, and, in compliance with GMP
Annex 1, their potential source.

This is the definition of what the CCS will aim to achieve: controlling specific contamination.

Position

Next, you will want to position the CCS relative to your process and facility design. According to
Schmitt, “The CCS will be related to the site master file and the site’s pharmaceutical quality
system (PQS), as well as the life cycles for the products manufactured on site.”

Establish

Finally, you’ll want to establish your CCS’s structure. Normally, you will have a Site Master CCS
which covers the whole facility, along with a number of more specific CCS documents
addressing area and product specific needs.

What Should You Include In Your CCS?

When you’re developing the details of your CCS, you will need to include anything related to
contamination. This includes:

Airflow strategy.
Filtration strategy.
HVAC, heating, and ventilation systems.
Gowning protocols.
Housekeeping.
Material storage.
Personnel flow.
Material flow.
Facility design.
Equipment design.
Process decision.
Process controls.
Preventative maintenance.
Utilities.
Cleaning and disinfection.
Outsourced activities.
Essentially, anywhere that contamination can get in and affect the product, you need to create a
plan for managing it. GMP Annex 1 dictates that process, equipment, and product knowledge
should play a heavy role in developing the CCS.

Beyond the technical control measures that impact process, product, and risks, you should also
include organization and control measures based on quality risk management. For example,
there should be protocols and plans in place in the event of contamination, including your
response, mitigation, and corrective measures.

Documenting Your CCS

You will want to keep written documentation of your CCS, as well as proof of compliance. This is
easier to do with more modern equipment that helps you track information in accordance with
regulatory requirements. Even with the equipment, you will want to ensure you follow data
integrity standards (https://www.golighthouse.com/en/blog/data-integrity-in-your-
contamination-control-strategy/), like ALCOA+.

ALCOA+ is the FDA’s definition of data integrity. It stands for:

Attributable: The person who recorded the data should be clear, including a signature and
date.
Legible: Data should be easily and clearly understood, including an explanation for any
symbols used.
Contemporaneous: Data should be recorded immediately.
Original: Only original or a certified copy of the data should be included.
Accurate: Data should accurately reflect the situation or observation.
Complete: Records should include everything, such as testing and re-testing.
Consistent: Data generation should be consistent and time stamps should be sequential.
Enduring: Data should only be recorded using invalidated electronic systems (or, if
unavailable, controlled worksheet in laboratory notebooks).
Available: Record of the data should be readily available for review and audits for the
lifetime of the record.
Are You Staying Up To Date?
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