Decontamination _ Decommissioning .pptx-

4
Hazard product
need an
dedicated area
Slide 4 of 29
Unused hazard
dedicated area
(Needed this area)
Hazard area
shared in facility
Unused hazard
dedicated area
(unneeded this
area)
Critical and major
change in a
hazard used area
Cleaning validation
& risk assessment
for campaign
Cleaning validation
& risk assessment
for decontamination
without demolition
Change control ,
Cleaning validation
& risk assessment
for decontamination
Cleaning validation ,
risk assessment &
closure plan for
decontamination
Cleaning validation
& risk assessment
for decontamination
with demolition
No available
dedicated area
and There is
a market need
Burden on the
business & There is
another marketing
opportunities
Regulatory &
external audit
requirement
Source of
contamination
Business
continuity need &
Regulatory
requirement

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1 – Background
Decontamination & Decommissioning are a general term used to describe the process of removing
pharmaceutical facility from active status.
There are many factors to consider in this process including documentation required, process
management, Environment, Health, and Safety (EHS) requirements, compliance, financial,
operational, and maintenance requirements and supporting contracts, as well as interfaces with
other facilities and site utilities.
2 – Overview
The closedown of a pharmaceutical facility needs to be managed to ensure business continuity and
GxP compliance up to, during, and post closure. This should be managed in a planned, controlled
and cost-effective way that ensures a consistent supply of product for patients and a positive future
for employees.
It is recommended that a decommissioning project plan is created at an early stage with all
stakeholders.

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3 – Scope
This session is intended to provide information on industry good practices to be used for the
decontamination , decommissioning and disposal of pharmaceutical assets ranging from a single
item of equipment to an entire facility.
4 – Benefit
This session provides benefits including:
• Incorporation of a risk-based approach
• Consideration of both regulatory and business needs
• Definition of a structured process
• Provision of examples and templates
It is recommended that a decommissioning project plan is created at an early stage with all
stakeholders.

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5 – Purpose and Objectives
This session is intended as a “one-stop-shop” for basic information required for the
decontamination & decommissioning of equipment and facilities. It is the intent of this Guide
session is to highlight methods and systems that would satisfy the requirements of
Regulatory Authorities based on practices that have been developed in Egypt.
6 – Documentation
The checklists supplied with cleaning validation & risk assessment study provide a list of items to
consider when planning decontaminating & decommissioning activities. It is recognized that (SOPs),
as well as local regulations, may vary by site.
The process to define the decontamination & decommissioning activities should be based on risk.
This is defined by the risk assessment study which are key to the process of this guidance. All of the
items, systems, and processes to be decontaminated & decommissioned should be assessed and
categorized as either Good Engineering Practice(GEP) or Good “x” Practice (GxP). Several activities
may be common to both GEP and GxP.
The Project Manager, EHS representative, or Engineer should apply professional judgment and
knowledge to the planning of decommissioning activities.

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1 – Key Concepts
The term GxP is used within this session to show that all areas of Good
Practice, required by the relevant pharmaceutical regulations, need to be
considered.
Concepts and Responsibilities
2 – Responsibilities
Head of Quality Assurance (QA)
Head of Engineering
Area Manager
System Owner
3 – Tests
It is the responsibility of the QC person executing the test to ensure that the
decontamination activities are performed as stated in the protocol/cleaning
validation and are correctly documented and reported.

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1 – Background
The decontamination and/or decommissioning of a pharmaceutical facility is
rigorous and typically involves some level of regulatory agency review,
regulatory inspection/survey, and permit or license closure or transfer.
Regulatory Requirements
2 – Pharmaceutical Regulatory Authorities
The regulatory requirements for cleaning validation and risk assessment for
decontamination are usually less clear than decommissioning & demolition
operations; however, the same basic rules apply.
Routine activities require regular checks, periodic reviews, and revalidation
activities to document that the status passed at start-up is maintained
throughout the operational life cycle of a system. When a system is retire or
decommissioned, these checks should be performed again to verify that the
appropriate state has been maintained at the end of the operational life of the
system.

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3 – Other Regulatory Authorities
Several state environmental agencies require a final environmental closure
assessment. Hazardous and non-hazardous waste generation may require final
disposal with appropriate documentation (manifests) that provide a complete
tracking from the transporter to the disposal site. Controlled substances will
also require similar tracking with documentation for appropriate destruction
of the materials.
Regulatory Requirements
4 – Regulatory Approvals
Regulatory agencies and bodies responsible for facility permits and licenses
regulating hazardous, biological and controlled substances in pharmaceutical
facilities will vary from region to region.

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ure Planning
Planning for the closure of a manufacturing facility should be comprehensive and will
involve a broad range of activities supported by multiple business and technical disciplines.
Closure of existing manufacturing facilities and removal of production assets from
operational use follow a life cycle process. The life cycle starts with defining and approving
the business case for closure and concludes with attaining the desired future state.
A Closure Plan should be developed and should provide sufficient detail to allow the
implementation, management, and completion of the closure process; the plan may begin
as a strategy document used to obtain agreement between all parties of the concepts. The
following topics should be included and developed in the Closure Plan:
• Strategy development • Business case summary
• Scope • Business impact
• Requirements • Activities
• Deliverables • Transformation steps

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mmon Practices for GEP and GxP
1 – Health and Safety
1–1 Health and Safety Plan (HASP)
Safety Plans
• Chemical Hygiene Plan
• Emergency Response Plan
• Exposure Control Plan
• Spill Prevention
• Control and Countermeasure Plan
• Waste Guide
Recommendations
of HASP
• Site hazard assessments
• Personnel protective equipment
• Decontamination procedures
• Site controls
• Site communications
• Emergency Contingency Plan

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mmon Practices for GEP and GxP
1–2 Training
Personnel should be trained on the requirements of the Decontaminating & Decommissioning
HASP prior to and during (as necessary) decontamination/decommissioning activities.
1–3 Working Planning and Exposure Control
Where feasible, exposure control during cleaning and decontamination activities
should be accomplished through engineering, PPE, and procedural controls.
Engineering Controls Personal Protective Equipment Procedural Controls
AHU
Hot Zone
Decontamination
Zone
Risk Assessment
PEE
SOP
Solvent containers
storage
Site inspections air pressurizations
PPE listed
No lone working
Solvent dispensing

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Decontamination & Decommissioning Process

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Decontamination Process

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Decontamination Process Decontamination phases

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d Engineering Practice GEP Decommissioning Dossier

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Asset Disposal Process Flow

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Decommissioning/Asset Disposal

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Phase I
Phase II
Phase III
Phase IV
Initial assessment
Historical review Initial decommissioning
assessment report
Future use
Sampling and analysis Decommissioning/remediation
/demolition plan
Remediation Final status survey Demolition
Final status report

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Decontamination
Remediation is the process of decontaminating a space which includes actual
decontamination and analysis to confirm that the decontamination has met
the predefined limits.
Decontamination is a process of removing contaminants, usually hazardous
substances, to an acceptable level.
Mitigation is the process of providing controls to reduce a risk.
Remediation, decontamination, and mitigation should be performed when:
• There will be demolition or repurposing of an area or facility
• Waste generation/disposal occurs
• Assessment results indicate they are necessary

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Decontamination
Common Contaminants Requiring Remediation
Risk Assessment
Risk assessment should be performed throughout the project. It should
involve potential hazard identification ranging from a historical analysis to
current use and to performing a facility design review.
Implementing Remediation and Mitigation Process
Review of the results can help the development of the decontamination
strategy, e.g., if significant contamination is found inside ductwork, the
method used for dismantling and removal will require definition in the plan;
otherwise decontamination may be required before removal.

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Decontamination
Remediation Plan
6- Initiate remediation plan
7- Demolition as needed
8- Waste generation/disposal
9- Sampling analysis/observation
5- Establish communications process for remediation work
4- Review and approve plans
3- Consider possibility of finding something unforeseen
2- Coordinate with design/construction
1- Develop remediation plans
10- Review
11- Acceptance

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Decontamination
Verification of Decontamination and
Remediation
The four major elements of
decommissioning verification are:
1. Verification of decontamination
2. Verification of sampling and analysis
3. Verification of compliance to original
scope
4. Verification of compliance to relevant
standards
Required Documentation
The decontamination and/or remediation
report may be subject to regulatory
approval and should consist of:
1. A decontamination and/or remediation
plan
2. A site decontamination and/or
remediation report
3. A statement of “acceptable level of risk”
for re-occupancy or demolition

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Demolition
If the decision is made to demolition a facility, a number of steps should be taken to
safeguard the personnel working at the site and the surrounding community. These
preparatory operations involve the overall planning of the demolition job, including the
methods to be used to bring the structure down, the equipment necessary to do the
job, and the measures to be taken to perform the work safely. Planning for a demolition
job is as important as actually doing the work; therefore, all planning work should be
performed by a competent person experienced in all phases of the demolition work to
be performed.
Sample Decommissioning Documents
Police and Fire Contact
Medical Services and First Aid
Demolition Plan
Utility Location
Engineering Survey

• What might go wrong or
has gone wrong?
• What is likelihood or
probability?
• What are the
consequences (severity)?
• What is the level of risk?
Any mitigating factors?
Risk Review
Risk
Communication
Risk Assessment
Risk Evaluation
unacceptable
Risk Control
Risk Analysis
Risk Reduction
Risk Identification
Review Events
Risk Acceptance
Initiate
Quality Risk Management Process
Output / Result of the
Quality Risk Management Process
Risk
Manage
m
ent
tools
Slide 26 of 29

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Amendment List
1
PURPOSE
2
SCOPE & HISTORY
3
RESPONSIBILITIES
4
DEFINITION OF AREA TO BE DECONTAMINATED
5
Decontamination phases
6
PRE-DECONTAMINATION PROCEDURE
7
Phase 1: Decontamination for non-contact utilities:
8
Phase 2 AHU & Duct decontamination
9
DECONTAMINATION METHOD FOR LAB & PRODUCTION FACILITIES: (Phase 3 & Phase 4)
10
CLEANING PROCEDURES
Cleaning Procedure C-1: Pressure Wash
11
Cleaning Procedure C-2: Low-Pressure and/or Manual Wash
12
DECONTAMINATION PROCEDURE
Process oversight
13
Decontamination Procedure
14
GOWNING AND ACCESS PROCEDURE
15
Verification of successful Decontamination overview
Sampling Strategy
16
Swabbing Technique
17
E)Required Recorded
18
N)LOGBOOK PROCEDURE
19
COMPLIANCE REPORT
B-LACTAM DECONTAMINATIONOF FACILITIES
ATTACHMENT 1
20
COMPLIANCE REPORT
CEPHALOSPORIN DECONTAMINATION OF EQUIPMENT
ATTACHMENT 2
21
ATTACHMENT 3-A: CLEANING/DECONTAMINATION PERSONNEL TRAINING SIGN-OFF SHEET
22
ATTACHMENT 3-B: 1% Sodium Hypochlorite DECONTAMINATION Solution Preparation Data Sheet
23
ATTACHMENT 4: MSDS Sheets for Cleaning and Decontamination Solutions
24
Personal flow lay-out
25
Machine flow exit lay-out
26

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- Decommissioning of Pharmaceutical Equipment and Facilities (ISPE)
- Risk-Based Manufacture of Pharmaceutical Products (ISPE)
- Commissioning and Qualification (ISPE)
- Heating, Ventilation, and Air Conditioning (HVAC) (ISPE)
- WHO good manufacturing practices for pharmaceutical products containing hazardous substances
Annex 3 TRS-957
- WHO guidelines on quality risk management Annex 2
- Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination
(FDA)
- WHO GMP for Biological Products
- WHO Guidelines for Safe Disposal of Unwanted Pharmaceuticals in and after Emergencies
- CFR21
- QUALITY RISK MANAGEMENT ICH Q9
- Case study: :"10 Decontamination Practices and Principles." National Research Council.
2005. Reopening Public Facilities after a Biological Attack: A Decision Making Framework.
Washington, DC: The National Academies
- Case study: An Approach for Decontamination of b -Lactam Antibiotic Residues or
Contaminants in the Pharmaceutical Manufacturing Environment (Chem. Pharm. Bull. 54(9))
- Case study: Handling of Highly Potent Pharmaceutical Compounds (Chimica Oggi - Chemistry
Today - vol. 32(3) May/June 2014)
- Case study: Decontamination of a Biologics Production Facility

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