Inspections, Compliance, Enforcement, and Criminal Investigations

Page 18

Guide to Inspections of Medical Device Manufacturers
December 1997
 

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Contamination Control - There should be written cleaning procedures and schedules adequate to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality.

Verify the washing and toilet facilities for production and laboratory personnel are clean and adequate.

Verify, where special clothing requirements are necessary to ensure a device is fit for its intended use, there are clean dressing rooms provided for personnel.

Verify there are procedures designed to prevent contamination of equipment, components or finished devices by rodenticides, insecticides, fungicides, fumigants, hazardous substances and other cleaning and sanitizing substances, if used. Verify these procedures are adhered to, when they exist.

Verify eating, drinking, and smoking by personnel are limited to designated areas when such activities could have an adverse effect on a device's fitness for use.

Verify all sewage, trash, byproducts, chemical effluent and other refuse is disposed of in a timely, safe and sanitary manner.

Personnel - Each manufacturer must have written requirements for health, cleanliness, personnel practices and clothing of personnel if contact between such personnel and the environment could reasonably be expected to have an adverse effect on product quality. The manufacturer must assure maintenance or other temporary personnel required to work in specially controlled environments are properly trained or supervised by a trained individual.

Verify personnel in contact with the subject device or its environment are clean, healthy and suitably dressed per the firm's requirements. Verify personnel who, by medical examination or supervisory observation, appear to have a condition which could adversely affect the device are excluded from affected operations until their condition is corrected. Verify the firm's written procedures require personnel to report such conditions to their supervisor.

Equipment - Equipment used in the manufacturing process must be appropriately designed, constructed, placed and installed to facilitate maintenance, adjustment and cleaning.

Where maintenance of equipment is necessary to assure manufacturing specifications are met, verify there is a written procedure/schedule for maintenance and written documentation showing the scheduled maintenance activities are performed. Where a piece of equipment has inherent limitations or allowable tolerances, verify they are visibly posted on or near each applicable piece of equipment or is readily available to personnel responsible for performing maintenance on or operating that piece of equipment.

Verify the manufacturer is performing periodic inspections per written procedures to assure they are adhering to their applicable maintenance schedules.

Verify any inherent limitations or allowable tolerances are visibly posted on or near equipment that requires periodic adjustment. If not, they should be readily available to personnel performing these adjustments.

When manufacturing material could reasonably be expected to adversely effect the quality of a product, verify the material is being removed from the product or limited to a specified amount that will not adversely affect the product's fitness for use. Assure this use and removal or limitation is being done in accordance with written procedures. Verify the removal or limitation of the manufacturing material is documented.

When computers or automated data processing systems are used as part of the production or quality system, verify the software has been validated for its intended use according to a written protocol. Verify changes to this software are validated before approval and issuance. Verify these validation activities are documented. See Process Validation section above.

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