During COVID-19 Epidemic the Unusual Flexibilities for Maintenance and Calibration Activities

Medicines and Health care products Regulatory agency (MHRA) are allowing alternative courses of actions for manufacturing or Quality control laboratory equipments or instruments during the outbreak.

During the corona virus pandemic it may not be possible for service personnel or external engineering support to operate as normal hence the following options are available to manufacturers and GxP laboratories.

If an engineer is available to attend site

A risk assessment should be performed to assess COVID-19 transmission risks in line with government advice.

Company health and safety procedures should be followed so the engineer can ensure social distancing and be supervised adequately during their time on site.

Calibration and maintenance protocols may be reviewed prior to the engineer visiting the site as per routine requirements, however, approval may be given electronically and Site visit documentation may also be signed electronically.

If an engineer cannot attend site but is available by either telephone or video call

A suitably trained employee may perform the calibration or maintenance task under the remote supervision from the engineer providing the site has all the required materials, parts and tools to perform the task.

The risks of this should be assessed and if required, the next maintenance or calibration task brought forward once current restrictions are lifted.

If an engineer is not available to attend site and remote supervision is not possible

A quality system record (e.g. change control or deviation) should be raised and the delay to the calibration or maintenance task should be risk assessed, considering;

  • The criticality of the equipment and its intended use
  • Frequency of the calibration/maintenance
  • Whether it is an interim or annual recalibration/maintenance task
  • Prior performance, including ‘drift’ between previous calibration or maintenance visits and recent breakdown history
  • Performance checks that are performed on the equipment prior to use
  • If alternative equipment is available to perform the task and is within its calibration/maintenance period

The risk assessment should also consider additional performance checks and verifications that should be performed to monitor the compliance status of the equipment.

The delay to a calibration or maintenance task should be documented and managed by the quality management system.

The documentation should be transparent to allow the person responsible for releasing product or making a regulatory claim of compliance to make a full and accurate assessment.

The calibration or maintenance task should be performed at the earliest when current restrictions on movement are removed and Equipment taken out of service following risk assessment should have outstanding maintenance or calibration work completed prior to being put back into use.

Off-site calibration/maintenance

There may be an option for controllable equipment to be shipped off-site for calibration or maintenance to be performed.

If this is not standard practice then the change should be assessed, detailing the risks of equipment leaving the site and the impact on the calibration or maintenance once the equipment has been returned and an assessment made as to whether it is fit for the intended use.

Substitution of laboratory equipment

Any analytical methods that may have been validated on a specific make/model of equipment may be transferred to an equivalent instrument after assessment of the impact on the validation status of the method.

If required, method validation may need to be performed to ensure the validity of the results generated.

Conclusion:

Each Pharmaceutical or Health care manufacturing and Quality control laboratory organization shall prepare the SOP for their respective sites for better compliance and it is required for domestic as well as regulatory Export markets.

Reference : https://www.gov.uk/guidance/guidance-for-manufacturers-and-good-practice-gxp-laboratories-on-exceptional-flexibilities-for-maintenance-and-calibration-during-the-coronavirus-co

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s