Proper Production and Process Controls are critical to ensuring that a medical device conforms to its established specifications. These controls are used to define where deviations from the device specifications could occur as a result of the manufacturing process. Section 820.70 of the FDA Code of Federal Regulations Title 21 defines the Production and Process Controls that a manufacturer must develop, maintain, and use to monitor production processes.
The General Process Controls that a manufacturer shall use in their production operation are:
- Detailed work instructions, standard operating procedures, or operating methods that are used to define and control the manner of production.
- The ability to monitor any applicable process parameters, and any device or component characteristics during production.
- The ability of the production process to comply with specified reference standards or codes.
- Documented standards that detail the criteria for the approval and release of products, processes, or process equipment.
A manufacturer must develop and maintain procedures for updating production specifications, methods, processes, or procedures. When changes are made to the production process, the production process must be verified or validated according to 21CFR 820.75 to ensure the finished product is able to meet the established specifications. The records of the changes made must adhere to the manufacturer’s Document Control procedures.
The environmental conditions (ex. temperature, humidity, air cleanliness, microbial bioburden) of the production area are to be controlled and maintained within established levels that have been shown to not have an adverse effect on product quality. The control of the environmental conditions shall be periodically reviewed to ensure that the control system and associated equipment are functioning properly, and are able to consistently provide the required environmental conditions.
A manufacturer will create and maintain requirements for the health, cleanliness, practices, and attire of all personnel who work with or come in contact with the product or production environment. Personnel that do not normally work in the production areas will receive training or be supervised by a trained individual while working in the production area.
The buildings that house the production areas must be constructed of a suitable design, contain sufficient space to perform all necessary operations, and be designed to help prevent mistakes from occurring and to assure orderly handling of products and materials. A manufacturer will also develop and maintain procedures to help prevent contamination of equipment, product, or production areas by substances that could affect product quality.
A manufacturer must ensure that all equipment used in the manufacturing process meets defined specifications, and is appropriately designed, constructed, and installed to allow for maintenance, adjustment, cleaning, and operation. Qualification or validation of the equipment may be required according to 21CFR 820.75.
- The manufacturer will keep schedules for the inspection, adjustment, cleaning, and any other maintenance activities. Records of the maintenance activities, including the date the maintenance was performed, and the personnel who performed the maintenance, shall be documented per the manufacturer’s Document Control procedures.
- The manufacturer will also ensure that the limitations and allowable tolerances of any equipment that requires periodic adjustment are posted near the equipment or are readily available to the personnel performing the maintenance.
A manufacturer will establish and maintain procedures for the testing, acceptance, or removal of the materials to be used in the manufacturing process. The procedures will include the procedures for removing or limiting the use of any material that may have an adverse effect on the product quality. All testing, acceptance, removal, or limited use of the materials will be documented per the manufacturer’s Document Control procedures.
If computers or automated data processing systems are used as part of production or the quality system, a manufacturer must validate the computer software for the intended use. All software changes will be validated before approval and usage. All of the validation activities will be documented per the manufacturer’s Document Control procedures.
A knowledgeable Mesa representative is available to assist with any questions you may have. Please contact us for more information on the FDA Code of Federal Regulations Title 21, Section 820.70, and to learn how Mesa can help at your facility.