Cynthia Green, RAC

Your Company’s Name Effective Date:

Standard Operating Procedure

Document Number: Title: Page:

Environmental Controls 1 of 5

1. PURPOSE
1.1 To provide guidance concerning environmental controls at the company.
1.2 To define the elements of an Environmental Control Program (ECP) and the areas that
are governed under the program.

2. SCOPE
2.1 This document applies to all company personnel involved in the ECP.

3. RESPONSIBILITY
3.1 It is the responsibility of the Program Manager to coordinate the environmental control
activities of the departments and team members.

4. REFERENCES AND APPLICABLE DOCUMENTS

4.1 21 CFR 820.70(c)
4.2 ISO 9000:2000, ISO 13485:1996, EN 46001:1996
4.3 Document No. xxxx, “Corrective Action and Preventative Action (CAPA)”
4.4 Document No. xxxx, “Management Responsibility”

5. DOCUMENTATION REQUIREMENTS
5.1 None

6. DEFINITIONS
6.1 Action Level: A level that, when exceeded, indicates a process has drifted from its normal
operating range. A response to such an excursion should involve a documented investi-
gation and corrective action.
6.2 Alert Level: A level that, when exceeded, indicates a process may have drifted from its
normal operating condition. Alert levels constitute a warning, but do not necessarily war-
rant corrective action.
6.3 Cleaning: Chemical or physical means used to remove soil and/or microorganisms from
surfaces.
6.4 Continuous monitoring: A process of data collection where conditions are monitored con-
tinuously. In most United States applications, this definition implies, “during production.”
For ISO applications, this means twenty-four hours per day, seven days a week.
6.5 Controlled Area: Area where unsterilized product, in-process material, and containers/clo-
sures are manufactured or prepared. Different types and levels of controlled areas exist,
and, depending on their function, different class designations and resulting conditions are
maintained.
6.6 Corrective Action: Actions to be performed that are in SOPs, and are initiated when cer-
tain conditions are exceeded.
6.7 Critical Area: Area where sterilized products or containers/closures are exposed to the
environment.
6.8 Dynamic Monitoring: Monitoring of an environment during normal operations, e.g., equip-
ment operating, personnel present, and the process or simulated process is ongoing. Per
EU and ISO documents, this is synonymous with an operational condition.

C o n d u c t i n g Au d i t s, G A P A s s e s s m e n t s, & C o r r e c t i ve A c t i o n s 79
Cynthia Green, RAC

Your Company’s Name Effective Date:

Standard Operating Procedure

Document Number: Title: Page:

Environmental Controls 2 of 5

6.9 Environmental Control Parameters: Conditions and corresponding measurements as as-

sociated with facilities and equipment utilized in the manufacturing process that may im-
pact the identity, strength, quality, or purity of a product. Among such parameters are air-
flow rates and patterns, pressure differentials, materials, personnel flow, temperature, rel-
ative humidity, as well as non-viable and viable particulates.
6.10 Non-Viables: A term used in reference to particulates, that are not capable of living, grow-
ing, or developing and functioning successfully; unable to divide.
6.11 Preventive Action: Action taken to eliminate a potential nonconformance, defect, or other
undesirable situation in order to prevent occurrence.
6.12 Risk Analysis: A determination made to assess the hazards and consequences associ-
ated with an occurrence.
6.13 Viable: Capable of living.

7. GENERAL INFORMATION
7.1 Environmental conditions reasonably expected to have an adverse effect on the quality of
a product or process must be controlled. The establishment of an ECP within the com-
pany is a means of ensuring a balanced environment, as well as compliance to specified
requirements for product safety, performance, and reliability.
7.2 The purpose of the ECP is to define, establish, implement, and maintain a level of envi-
ronmental control that is consistent with the requirements identified. The ECP is more
than just environmental monitoring. Environmental monitoring is only one tool that is
used to measure the success of the program.

8. PROCEDURE
8.1 General Approach for Establishing an ECP
8.1.1 Define the project’s scope
8.1.2 Obtain Executive Management approval to fund and support the project.
8.1.3 Assign responsibilities.
8.1.4 Perform a risk assessment to identify the primary level of concern.
8.1.5 Evaluate the identified risks for potential impact (product, personnel, regulatory, etc.).
8.1.6 Prepare a list of action items with target dates for completion.
8.1.7 Assign responsible individuals.
8.1.8 Prepare a work plan for each area. Capture team member responsibilities, resource
requirements, regulatory risks, technical risks, and assignments.
8.1.9 Once actions have been completed, verify completion.
8.1.10 Monitor to ensure that corrective actions have been effective.
8.1.11 Perform both random and scheduled audits to document adherence to the estab-
lished plan and compliance to applicable regulations.
8.1.12 Provide feedback from the audit to the CAPA program as described in monitoring pro-
cedures. (Refer to Document No. xxxx).
8.2 Overview of Elements of the ECP
8.2.1 Facilities design and operation
8.2.1.1 Assign the responsibility for environmental control in the facility area to the Facili-
ties Manager.

80 I n s t i t u t e o f Va l i d a t i o n Te c h n o l o g y
 Cynthia Green, RAC

Your Company’s Name Effective Date:

Standard Operating Procedure

Document Number: Title: Page:

Environmental Controls 3 of 5

8.2.1.2 Include the administration of the assignments as set forth by the Program Manager
to ensure that the facility operates, and is maintained in a manner that will mini-
mize the potential risk of product contamination originating from the materials of
construction, and the Heating, Ventilation, and Air Conditioning (HVAC) system.
8.2.1.3 Evaluate and document:
8.2.1.3.1 The current status of the general condition of the facility, including general
appearance, state of repair, adjacent grounds
8.2.1.3.2 The HVAC system, including zone mapping and separation of activities,
and current operating condition
8.2.1.3.3 SOPs that are relevant to establishing and maintaining environmental con-
trols. These procedures include:
(List the SOPs here for mechanical rounds, HVAC system operation and
maintenance, pest control, building maintenance and repair, maintenance of
lighting, and similar documents)
8.2.1.3.4 Items identified as needing improvement
8.2.1.3.5 New procedures required to support the ECP in the facilities area
8.2.2 Utilities
8.2.2.1 Assign the responsibility for utilities to the Facilities Manager.
8.2.2.2 Include the administration of the assignments set forth by the Program Man-
ager to ensure that the utilities used in the production facility operate consis-
tently in a manner that will minimize potential risk of product contamination.
8.2.2.3 Evaluate and document:
8.2.2.3.1 The current status of the utility systems, including state of repair and main-
tenance of the water, compressed air, vacuum, and nitrogen systems
8.2.2.3.2 SOPs that are relevant to establishing and maintaining environmental con-
trols. These procedures include:
(List the SOPs here, such as water system operation and maintenance, and
similar ones for the other utilities.)
8.2.2.3.3 Items identified as needing improvement
8.2.2.3.4 New procedures required to support the ECP in the utilities area
8.2.3 Manufacturing Processes
8.2.3.1 Assign the responsibility for manufacturing processes to the Production Man-
ager.
8.2.3.2 Include the administration of the assignments set forth by the Program Man-
ager to ensure that the manufacturing processes are performed consistently in
a manner that will minimize potential risk of product contamination.
8.2.3.3 Evaluate and document:
8.2.3.3.1 Production processes with respect to potential environmental exposure
and risk of contamination
8.2.3.3.2 SOPs that are relevant to establishing and maintaining environmental con-
trols. These procedures include:
(List the SOPs here, such as filtering, handling of solutions, dispensing, bulk-
ing, or compounding, etc.)
8.2.3.3.3 Items identified as needing improvement

C o n d u c t i n g Au d i t s, G A P A s s e s s m e n t s, & C o r r e c t i ve A c t i o n s 81
Cynthia Green, RAC

Your Company’s Name Effective Date:

Standard Operating Procedure

Document Number: Title: Page:

Environmental Controls 4 of 5

8.2.3.3.4 New procedures required to support the ECP in the process area
8.2.4 Cleaning
8.2.4.1 Assign the responsibility for cleaning to the Production Manager.
8.2.4.2 Include the administration of the assignments set forth by the Program Man-
ager to ensure that cleaning is performed consistently in a manner that will
minimize the potential risk of product contamination.
8.2.4.3 Evaluate and document:
8.2.4.3.1 Cleaning processes with respect to potential environmental exposure and
risk of contamination
8.2.4.3.2 SOPs that are relevant to establishing and maintaining environmental con-
trols. These procedures include:
(List the SOPs here, such as facility, cleaning by janitorial service person-
nel, facility cleaning by in-house personnel, cleaning if work surfaces,
equipment cleaning, preparation and storage of cleaning solutions, mainte-
nance of mops and cleaning equipment, etc.)
8.2.4.3.3 Items identified as needing improvement
8.2.4.3.4 New procedures required to support the ECP in the cleaning area
8.2.5 Raw Materials and Components
8.2.5.1 Assign the responsibility for qualification of incoming materials to the Quality
Control (QC) Manager.
8.2.5.2 Include the administration of the assignments set forth by the Program Man-
ager to ensure that qualification is performed consistently in a manner that will
minimize potential risk of product contamination.
8.2.5.3 Evaluate and document:
8.2.5.3.1 The raw materials and components that are likely or somewhat likely to
contain significant bioburden
8.2.5.3.2 Procedures for testing bioburden of materials and components
8.2.5.3.3 SOPs that are relevant to establishing and maintaining environmental con-
trols. These procedures include:
(List the SOPs here, such as bioburden testing of raw materials, stability
test procedures for raw materials, etc.)
8.2.5.3.4 Items identified as needing improvement
8.2.5.3.5 New procedures required to support the ECP in the raw material area
8.2.6 Personnel
8.2.6.1 Assign responsibility for personnel to the Program Manager.
8.2.6.2 Include the administration of the assignments to ensure that personnel are
trained and perform assignments consistently in a manner that will minimize
potential risk of product contamination.
8.2.6.3 Evaluate and document:
8.2.6.3.1 Personnel training in gowning, aseptic processing, hygiene, traffic flow,
changeover between products, etc.
8.2.6.3.2 SOPs that are relevant to establishing and maintaining environmental con-
trols. These procedures include:
(List the SOPs here, such as gowning, hygiene, traffic flow, changeover, training, etc.)

82 I n s t i t u t e o f Va l i d a t i o n Te c h n o l o g y
 Cynthia Green, RAC

Your Company’s Name Effective Date:

Standard Operating Procedure

Document Number: Title: Page:

Environmental Controls 5 of 5

8.2.6.3.3 Items identified as needing improvement

8.2.6.3.4 New procedures required to support the ECP in the personnel area
8.2.7 Preservative Systems
8.2.7.1 Assign the responsibility for establishing adequate preservative systems to the
Product Development Manager.
8.2.7.2 Include the administration of the assignments set forth by the Program Man-
ager to ensure that products have been, and will be, formulated in a manner
that will minimize potential risk of product contamination.
8.2.7.3 Evaluate and document:
8.2.7.3.1 Current preservative systems, and systems proposed for products in de-
velopment
8.2.7.3.2 Available data on product bioburden
8.2.7.3.3 Available data on preservative challenge studies
8.2.7.3.4 SOPs that are relevant to establishing and maintaining environmental con-
trols. These procedures include:
(List the SOPs here, such as preservative challenge testing, environmental
challenge studies, etc.)
8.2.7.3.5 Items identified as needing improvement
8.2.7.3.6 New procedures required to support the ECP in the preservative area
8.3 General Maintenance of the ECP
8.3.1 To ensure compliance to the ECP, develop and implement a maintenance plan for the
continual monitoring, assessment, and improvement of the ECP.
8.3.1.1 Feedback to the management review program is provided by status and activ-
ity reports generated from the maintenance plan.
8.3.2 Include the following areas in the maintenance plan:
8.3.2.1 Calibration program, including facility systems, production equipment, and test
equipment
8.3.2.2 Preventive maintenance program, including facility systems, production equip-
ment, and test equipment
8.3.2.3 Internal audit program, including random and scheduled audits of all functional
areas
8.3.2.4 CAPA, including activities of the management review
8.3.2.5 Training program, including both in-house, as well as outside activities
8.3.2.6 Environmental monitoring program, including surface, viable air, and nonviable
particle sampling and evaluation, as well as microbial water monitoring
8.4 Record Retention
8.4.1 Retain all appropriate ECP documentation according to the company’s policies and
procedures for record retention and applicable regulatory requirements. ❏

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