Committee F02 on Flexible Barrier Packaging Use of Standards – Premarket Submissions Auditing Packaging Process – Medical Device Inspections
FDA’s Involvement with Standards Food, Drug and Modernization Act 1997 – section 514 Requires CDRH to be involved in standards recognition. Develop a system which recognizes all or part of a national and international standard established by recognized standards development organizations.
FDA’s Involvement with Standards FDA publishes in the Federal Register the standards that are being recognized as well as standards that will be withdrawn. FDA maintains a database of recognized consensus standards. Firms can reference recognized consensus standards in a Declaration of Conformity, which can satisfy a premarket submission requirement.
FDA’s Involvement with Packaging Standards Latest edition of ISO 11607 addresses the ASTM test methods that may be used to validate the packaging process. 32 ASTM Packaging test methods/standards are referenced in ISO 11607. ASTM’s F02 standards provide detailed guidance and industry practices in regard to packaging testing. Keeps FDA informed of current best practices.
Recognition of Packaging & Shipping Standards CDRH’s Sterility Standards Task Group has recognized: ANSI/AAMI/ISO 11607-Parts 1 & 2. 19 ASTM Test Methods, Standard Practices, etc regarding packages and packaging material. D4169-09 - Standard Practice for Performance Testing of Shipping Containers and Systems.
Device Premarket submissions Using Standards in Premarket Submissions Premarket Notifications – 510(k) Submissions Premarket Approval Submissions - PMA
Premarket Submission Premarket Notification Submission – Demonstrating device to be marketed, is substantially equivalent to a device already on the market. (510k submissions - typically are Class II devices)
Premarket Submissions Medical device firms: Will voluntarily state conformance with recognized consensus standards. When a device manufacturer decides to recognize a consensus standard to meet a premarket requirement (i.e. sterilization validation), they must provide a declaration of conformance for the standard.
Recognition of Standards for Premarket Submissions Must maintain data to demonstrate conformance. This data may be requested by FDA at any time (typically during inspections). Failure to demonstrate or falsify conformance to a standard is a prohibited act. Devices will be considered misbranded.
Declaration of Conformity Benefits of stating Declaration of Conformity to a standard. Recognition of standards can minimize the data needed in premarket submissions. Less data to review can streamline the premarket submissions review.
510(k) Submissions for Sterile Devices What CDRH Reviewers look for: Sterilization method that will be used ( i.e. radiation or moist heat). The method that will be used to validate the sterilization cycle, but not the validation data itself.
510(k) Submissions for Sterile Devices What CDRH Reviewers look for: A description of the packaging to maintain the device’s sterility, not including package integrity testing data. For "pyrogen free” labeling, a description of the method used to make the determination, e.g., limulus amebocyte lysate (LAL). The sterility assurance level (SAL).
510(k) Submissions Declaration of Conformance to Test Methods: When a standard describes a test method but does not specify a performance limit or acceptance criteria, the manufacturer should submit the test results.
Declaration of Conformity Identify the recognized consensus standards. State all requirements met. Identify and explain inapplicable requirements or deviations from the standard. Specify any differences between tested device and the device to be marketed. Laboratory and certification body information used to determine conformance with the standard.
Premarket Approval Premarket Approval (PMA) – Evaluate the safety and effectiveness of a Class III device - Life supporting/Life Sustaining devices. Actual sterilization procedures and validation data will need to be submitted. Quality System procedures (Design controls, Purchasing (supplier) controls, Process controls, Calibration, etc.)
PMA Devices PMA submissions are more voluminous and take longer to review than 510(k) submissions. Premarket inspections of the sterilization facility may be needed.
Inspection Considerations Inspection of the Packaging Process Documents reviewed Quality System requirements evaluated
FDA Inspection of Packaging Process Evaluate Procedures – Ensure procedures meet FDA requirements and provide adequate instructions to complete the task. Personnel – Adequate resources. Experienced and trained personnel. Procedures are being implemented. Review testing done on sterile barrier system. Testing is done according to procedures.
FDA Inspection of Packaging Process Evaluate process controls procedures - When a non-conformance could occur, making sure process controls are implemented. Ensuring test equipment is calibrated (pressure gauges, timers) and routine maintenance is identified for equipment.
FDA Inspection of Packaging Process Confirm packaging process has been validated. Review production records from routine processed lots/batches to ensure the sterile barrier system or packaging system are within the validated parameters. Appropriate records are maintained, reviewed and approved before releasing product.
FDA Inspection of the Packaging Process Adequate controls established for nonconforming product. Purchasing/Supplier controls – for packaging material supplier or contract packager.
Inspecting the Packaging Process FDA inspections of the packaging process in medical device manufacturers often focus on process validation - 21 Code of Federal Regulation (CFR) 820.75. Packaging can be evaluated throughout the Quality System (QS) regulation:
Inspecting the Packaging Process 21 CFR 820.22 – Quality Audit Ensuring packaging process is being reviewed during quality audits. If a contract packager is used, ensure they are adequately evaluated and complying with the QS regulation. 21 CFR 820.25 – Personnel Training is documented. Personnel made aware of device defects which may occur from improper performance. Personnel that perform verification or validation – need to be aware of defects or errors that may be encountered from their job function .
Inspecting the Packaging Process 21 CFR 820.30 – Design Controls Packaging needs to be considered early in the design process. (Packaging engineers part of the design team, ensure packaging will protect the device, maintain sterile barrier, ensure packaging materials are not affected the sterilization process; design changes – do the impact the packaging.)
FDA inspection of the Packaging Process 21 CFR 820.50 - Purchasing Controls Establish procedures to ensure purchased or otherwise received product and services conform to specifications. Evaluate & select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements (quality requirements).
FDA inspection of the Packaging Process Purchasing Controls Define the type and extent of control to be exercised over the product, services, contractors, and consultants, based on the evaluation results. Establish and maintain records of acceptable suppliers, contractors, etc.
FDA inspection of the Packaging Process Purchasing Data Establish and maintain data that clearly describe or reference the specified requirements. Where possible, an agreement that the suppliers, contractors, or consultants agree to notify the manufacturer of changes in the product or service to determine if the change may affect the quality of the finished device.
Purchasing Control Problems Quality requirements are not established. List of acceptable suppliers or contractors not maintained. Inadequate controls implemented No assurance contract packaging process has been validated. Manufacturer assumes contractor performing packaging, however the packaging is outsourced to a third party.
FDA inspection of the Packaging Process 21 CFR 820.70 – Production and Process Controls Where deviations from a device specification could occur from manufacturing process, the manufacture shall establish process control procedures. (includes Production and process changes, Environmental Controls, Personnel, Contamination Control, Buildings, Equipment - Maintenance schedule, inspection, adjustment, manufacturing material, automated process)
FDA inspection of the Packaging Process 21 CFR 820.72 – Inspection, Measuring and test equipment Control of inspection, measuring and test equipment capable of producing valid results; Calibration - Calibration standards; Calibration records.
Recommend
More recommend
