Cleaning, maintenance and calibration programs are important because these three programs represent how qualified systems and processes are maintained in a state of compliance. Since these programs are often contracted out, there is an increased focus of acceptability of the vendors and how quality practices are assured namely by vendor audits.
Points to Remember
In cleaning, maintenance and calibration programs, results must be reviewed and approved by your own quality unit. If contracted service personnel follow your own procedures, documented training of contracted personnel is expected. Quality or supplier agreements should be in place clearly defining the responsibilities of both parties. Critical topics to address are applicable specifications, handling of failing results, sub-contracting and change control.
Regulatory Requirements for these Programs
Routine Maintenance and Cleaning: 21 CFR 211.67, equipment cleaning and maintenance, it states in section (a) that equipment and utensils will be cleaned, maintained and sanitized at appropriate intervals. Section B states that written procedures must be established and followed.
Issues Regarding Cleaning
Issues often cited by auditors regarding cleaning are the following: A.) how long can a “cleaned” item remain unused before “re-cleaning” is required? B.) what degree of “re-cleaning” is performed when required? Each issue is expected to be included in the applicable cleaning procedure.
Establishment of Frequencies
This is often the first thing that needs to be defined in procedures. Initial frequencies often based on manufacturer’s recommendations. Other critical factors to consider are: environment in which instrument operates, criticality of information provided, stability of results over time. Common to change once data is accumulated. Data is routinely reviewed and evaluated. Frequencies can either be time based or based on equipment responses, such as reduced flow rates, increased pressure differentials, decreased conductivity values and so on.
Common deficiencies under Preventive Maintenance are: Frequencies and procedures are not defined or followed as specified. Preventative Maintenances are not performed on due dates established. No or insufficient evaluation of impact on product if failures are encountered. Auditors will look at the trending of ‘causes’ for deviations or out of specification results that list equipment as the reason. This will result in an increased review of PM programs, their frequency and adequacy as the potential reason for ‘why’.