Specialty Pharmacy (4.0) 4.0

PROD 6-1: Machine and Equipment Maintenance

Submited by: Tom Goddard

The Basics

The pharmacy must implement written policies and procedures that:

  • ensure that all machines and equipment in the pharmacy are maintained according to both the guidelines provided by the manufacturers and any applicable regulations, and
  • provide for the documentation of the implementation of the processes dealing with cleaning, calibrating, and auditing of the machinery and equipment.

The machinery and equipment to which this standard refers include pill counters, medication dispensers, packaging equipment, and the like. This does not include cooling or label-printing machinery.

Management Tips

Your P&Ps don't need to parrot the contents of user manuals. Rather, if you'd prefer to lean on those manuals, simply reference them in your policies and describe how the relevant staff members have access to those manuals and/or are trained in how to use them. 
If the pharmacy outsources any maintenance or calibration to a third party, be sure that you can produce documentation of those services being provided.

Accreditation Tips

Desktop Review
Be sure to submit all of the following:

  • A comprehensive list of all dispensing and labeling equipment;
  • A policy and procedure that meets all of the elements of this standard;
  • Supplemental documentation of the implementation of the applicable policy, especially as it demonstrates timely cleaning, calibrating, and audit activities.
If, for some reason, the pharmacy has no equipment to which this applies, submit a signed attestation on organizational letterhead to that effect.
Validation Review
URAC's Accreditation Guide claims there will be no validation review activities regarding this standard. To be safe, be sure that the staff members responsible for the activities covered by this standard are prepare to discuss cleaning, calibrating, and auditing of machines and other equipment.

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