Information & Training. | Medical Devices.

FDA QSR Equipment and Maintenance

Equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. Equipment layout and design must aim to minimize risks of error and to permit effective cleaning and maintenance. Equipment needs to be designed so as to avoid cross-contamination, dust and dirt build-up and to avoid any adverse effect on the quality of products. Equipment must be installed to minimize risks of error and minimize risks of contamination.

Balances and Measuring Equipment.

An appropriate range and precision must be available. If used in production and quality control, must be calibrated on a scheduled basis and records need to be maintained.

Production Equipment (FDA QSR Equipment).

Must be of an appropriate design, be easily and thoroughly cleaned on a scheduled basis and have procedures in place and records maintained.

Equipment must not pose a hazard to product:

– contact parts need to be of suitable non-reactive material.

– must be non additive and not absorptive

Validation. Classification. Regulation. Requirements. Current best practices.
FDA cGMP’s. EU MDR’s / MDD’s.
FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
FDA Medical Device Classification. The FDA approach to Medical Device Classification.
EU Medical Device Regulation and Classification (per MDD’s).
^New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
Quality System requirements to maintain compliant Validations.
Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
Medical Device Software Validation.
Medical Device Design Validation.
Electronic Signature, Electronic Records.
Life Cycle Approach to Validation.
Risk Identification. Documentation. DHR’s. DMR’s.
Etc. Etc. …
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Defective equipment must be removed, or labelled to prevent use.

Closed equipment should be used when possible. Open equipment, or when equipment is opened, precautions need to be taken to prevent contamination.

Non-dedicated equipment needs to be cleaned according to validated cleaning procedures between different products.

Current drawings of critical equipment and support systems need to be maintained.

Control Laboratory Equipment (FDA QSR Equipment).

Equipment and instruments must be suitable for the tests to be performed

Defective equipment needs to be removed and appropriately labelled.

Washing, Cleaning and Drying.

Equipment used for washing and drying, must not become a source of contamination. Equipment design should promote easy cleaning. Cleaning should be performed on a scheduled basis, per defined procedures and have records maintained,

There should be clear indications regarding the compliance status of equipment or services (e.g. water, gas), defective equipment must be withdrawn. After use, production equipment should be cleaned without delay, stored under clean and dry conditions in a separate area. There should be defined time limits for storage of equipment after cleaning and before use. Containers for filling should be cleaned before use. Check pipelines and other pieces of equipment used for transportation of products. Pipes used for conveying distilled or deionized water need to be sanitized and stored according to written procedures (including action limits for microbiological contamination).

Equipment and instruments need to be serviced and calibrated at pre-specified intervals, have records maintained, checked daily or prior to use. Have clearly indicated the date of calibration and servicing, recalibration (label needs to be attached to the instrument). Repair and maintenance operations must not represent any hazard to the quality of the products.

Calibration.

The calibration labels must indicate the next due calibration date. Where calibration is not performed over the full available scale, then the calibration labels need to indicate limits of use. A full record of calibrations need to be maintained, including before and after test results, who performed the calibration, reference standards applied, environmental conditions if appropriate.

FDA QSR Equipment & Maintenance Regulations.

Subpart G–Production and Process Controls.

Sec. 820.70 Production and process controls.

(g) Equipment. Each manufacturer shall ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use.

(1) Maintenance schedule. Each manufacturer shall establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met. Maintenance activities, including the date and individual(s) performing the maintenance activities, shall be documented.

(2) Inspection. Each manufacturer shall conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules. The inspections, including the date and individual(s) conducting the inspections, shall be documented.

(3) Adjustment. Each manufacturer shall ensure that any inherent limitations or allowable tolerances are visibly posted on or near equipment requiring periodic adjustments or are readily available to personnel performing these adjustments.

Sec. 820.72 Inspection, Measuring, and Test Equipment.

a) Control of inspection, measuring, and test equipment. Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. The procedures shall include provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained. These activities shall be documented.

(b) Calibration. Calibration procedures shall include specific directions and limits for accuracy and precision. When accuracy and precision limits are not met, there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device’s quality. These activities shall be documented.

(1) Calibration standards. Calibration standards used for inspection, measuring, and test equipment shall be traceable to national or international standards. If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard.

(2) Calibration records. The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment.

Information & Training.

Medical Device:

- - Validation. Classification. Regulation. Requirements. Current best practices.
  - FDA cGMP’s. EU MDR’s / MDD’s.
  - FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
  - FDA Medical Device Classification. The FDA approach to Medical Device Classification.
  - EU Medical Device Regulation and Classification (per MDD’s).
  - ^New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
  - Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
  - Quality System requirements to maintain compliant Validations.
  - Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
  - Medical Device Software Validation.
  - Medical Device Design Validation.
  - Electronic Signature, Electronic Records.
  - Life Cycle Approach to Validation.
  - Risk Identification. Documentation. DHR’s. DMR’s.
  - Etc. Etc. …
  - Information & Training presentation >>>