Production and Process Controls for Medical Devices
It is essential to establish and maintain production and process controls within the quality system for a medical device’s manufacturing process. These controls help ensure that the device being manufactured meets its specifications and is safe to use.
Quality System Regulation (QSR) is comprised of current good manufacturing practice (cGMP) requirements for finished devices that are intended for human use. These requirements describe the methods, facilities and controls used for manufacturing, packaging, storage and installation of such devices.
In accordance with the QSR, each device manufacturer is required to establish and maintain a quality system that is suitable for the particular medical device being manufactured. A quality system will include the organizational structure, responsibilities, procedures, processes and resources needed for implementing quality management.
In addition to ensuring compliance with the FDA, the quality system and the regulations within QSR are intended to ensure that finished devices are safe to use. Certain controls specifically need to be implemented within the production process to ensure the devices meet their specifications, and are fully safe to use.
PRODUCTION AND PROCESS CONTROLS
Subpart G of the QSR specifies that production processes should be developed, conducted, controlled and monitored to ensure that devices conform to their respective specifications. Process controls may also need to be established if deviations from device specifications occur due to faulty manufacturing. Procedures need to be established for production and process changes, including changes to specifications, methods and standard operating procedures. Any such changes need to be verified or validated before they can be implemented.
Different aspects of the manufacturing process that need to be controlled are identified within this section. If environmental conditions could adversely affect product quality, procedures to control such conditions should be established. These environmental controls should be periodically inspected to verify that the system is functioning appropriately. Procedures also need to be maintained to prevent contamination of the product, or related equipment. In addition, it should be ensured that all equipment used in the manufacturing process is designed, constructed, placed, installed and validated according to specified requirements. Such equipment should be adjusted, cleaned and maintained according to schedules established by the manufacturer. Periodic inspection also needs to be conducted to guarantee that maintenance schedules are being appropriately followed.
The buildings in which production processes are performed are required to be designed suitably, and should contain sufficient space to perform operations and allow for orderly handling. Procedures should be established to remove or limit any manufacturing material that could adversely affect product quality. In addition, any limitations should be visibly posted on equipment, or made available to performing adjustments for the limitations. All personnel involved in the production process should follow requirements for health, cleanliness, personal practices, and clothing. These guidelines are also applicable to maintenance workers and other personnel working on a temporary basis.
It is essential to establish and maintain such production and process controls within the quality system to ensure that the devices being manufactured meet their respective specifications. This will also help ensure that the devices are safe to be used on, or by, humans.