FDA Current Good Manufacturing Practices and ISO 9000
Manufacturers of finished medical devices must
comply with the quality system requirements laid down in Current Good Manufacturing
Practice (cGMP) as defined in 21 CFR (Code of Federal Regulations), part
820. The latest version of the Food and Drug Administration's Current Good
Manufacturing Practice (cGMP) regulations were released in 1996. The requirements
for cGMP govern the methods, facilities, and controls used by manufacturers
in the design, manufacture, packaging, labeling, storage, installation,
and servicing of all finished medical devices. In the recent release of
the cGMP modifications, were made by the FDA to bring the standard closer
to alignment with the requirements set forth in ISO 9001. This effort resulted
in a regulation that is patterned after, but does not exactly mirror, the
ISO 9001 Standard. An overview of the similarities and differences between
the regulation and standard is provided below.
The similarities generally include:
-
The development and dissemination of a
quality policy
-
The development of a quality manual
-
Identification and documentation of organizational
responsibilities and authorities
-
Identification of resources requirements
and provision of such resources
-
Designation of a Management Representative
-
Performance and documentation of Management
Reviews
-
Development of a Quality System
-
Development of a file containing product,
manufacturing, and quality assurance specifications
-
Development and implementation of Quality
System Procedures including:
- Document and data control
- Purchasing Product identification and traceability
- Process control Inspection and testing
- Control of inspection, measuring, and test equipment
- Identification of inspection and test status
- Control of nonconforming product
- Corrective and preventive action
- Handling, storage, packaging, preservation, and delivery
- Internal quality auditing
- Training
- Servicing
- Statistical techniques
The differences are generally embodied within each element/requirement
of the standard/regulation but are briefly described below:
ISO 9001Requires
- Activities for consideration during quality planning
- Provision for contract review activities
- Design projects to be assigned to qualified personnel equipped
with adequate resources
- Organizational and technical interfaces to be defined,
documented, transmitted, and reviewed during the design process
- The verification of subcontracted products
- The control of customer-supplied products
- Control process for inspection, measuring, and test equipment
cGMP Requirements
- Design plans to be reviewed, updated, and approved as the
project evolves
- Design transfer control
- The effective dates of documents must be identified
- Label controls must be implemented
- Limitations or allowable tolerances must be available to
personnel performing equipment adjustments
- Manufacturer maintainance of specific distribution records
- The manufacturer must follow specific evaluation, reporting
and recall procedures for defective products
- The manufacturer must mark confidential quality records
- Manufacturer maintainance of quality records for no less
than 2 years from the date of release of the product for commercial distribution
- Manufacturer recording of specific data on records supporting
the manufacture of product
- The development of a Quality System Record
- Manufacturer recording of specific data on servicing records
If, as is common these days, a manufacturer were to consider
implementing both standards, it is important to ensure that a single system
is established and implemented which complies with both requirements. Also,
manufacturers who are considering selling devices to Europe must comply with
the Medical Device Directive which suggests that EN 46000 rather than ISO
9000 would be implemented and is even closer to the FDA cGMP requirements.
Cavendish Scott is experienced at helping clients achieve
cGMP compliance through training, consultancy and support.
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