Contamination risk.
The level of protection is based on the risk of contamination as assessed by the manufacturer. Assessment criteria include:
-
Duration of product exposure
- Product mix and product changeover (i.e., product changeover is the frequency of change of product processed in a room or
in a piece of equipment)
-
Characteristics such as potency or toxicity
-
Human activities performed in the manufacturing process
-
Facility design and performance factors
- Environment in which the plant is located.
Design conditions
and operating range
. Operating conditions are based upon product-acceptance criteria while design set points and conditions are target values
for the engineering designer to achieve. For example, a blending room may have a setpoint of 40% relative humidity (RH) and
a design range of 30–50% RH, but the product in that room may be unaffected by humidity in the range of 20–70% (i.e., validated
product-acceptance criteria). The acceptable operating range for the room is therefore 20–70%, not 30–50%. Additionally, nonproduct
requirements such as human comfort are also criteria in the design (4).
GEP.
GEP is defined as engineering practices that are applied throughout the business to provide organization and control, balance
risk and cost, and deliver appropriate and effective solutions. GEP describes an engineering-management system that is expected
in a pharmaceutical enterprise but not mandated by good practice quality (i.e., GxP) regulations. GEP recognizes that all
systems in a facility undergo some form of commissioning, which include inspection, testing, and documentation based on agreed
protocols. Direct-impact systems require enhanced documentation, which includes an enhanced design review, and quality-assurance
(QA) inspection and approval that are appropriate and acceptable to regulators. GEP capitalizes upon the suggestion that manufacturers
engage all stakeholders (i.e., engineers, managers, operators, and QA experts) early in the planning, design, construction,
commissioning, and qualification phases to ensure that systems are documented only once (5, 6).
Cost factors for an oral solid-dosage manufacturing facility
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Documentation. Appropriate documentation throughout the project for ensuring the equipment and facility is fit for its intended use is a
key element of GEP. Documentation should be reviewed, approved by appropriate subject matter experts, updated in a timely
fashion, and stored in a secure location for retrieval (1).
Major elements of the OSD guide
Quality risk management
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The OSD guide is subdivided into chapters that cover the following: regulatory philosophy; product protection, product, and
processing; architectural and facility design; process support and utilities; heating, ventilation, and air-conditioning (HVAC)
systems; electrical requirements; control and instrumentation; and other considerations. The appendixes provide insight into
cost factors for OSD manufacturing (see sidebar, "Cost factors for an oral solid-dosage manufacturing facility") and outline
the quality risk-management process and tools (see sidebar, "Quality risk management) (1).
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