[Stability Testing related News – vol.46]
◆ Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak (09-Apr-20 MHRA)
Due to the COVID-19 pandemic, remote working has increased. Some organisations have advised that their processes for approving paper documents with wet ink signatures are no longer achievable.
This guidance is to enable organisations to consider alternative methods whilst maintaining basic control of documents.
The guidance is for organisations involved in the pharmaceutical lifecycle (GMP, GDP, GLP, GCP & GPvP) or GLP studies regulated by the MHRA.
Existing electronic systems
Many companies already have validated systems that support electronic signatures on systems that are available remotely. If a company has these systems in place, then they should continue to use them.
Paper documents that were approved with wet ink signature
These are documents that have traditionally been printed on paper, physically handed to each reviewer in an office and approved using wet ink signatures.
Examples may include, but are not limited to:
- Validation protocols and reports
- Risk assessments
- Technical reports
- Quality management system documents that are paper-based such as SOPs, investigations and change requests.
These can be shared with remote workers, but they have no formal system describing how the review and approval can be recorded.
The solution will vary between organisations depending on the type of document and the tools available to the person performing the approval e.g. printer, scanner/smartphone, secure email, third party software or existing systems that have tools to capture electronic signatures.
Principles to maintain control
Regardless of what system or process is used, the following principles apply:
- Controls should be proportionate to the risk considering the type of document and the methods used for distribution and approval
- A signature performed remotely should be equivalent to the handwritten signature of the signatory
- The method of document distribution and approval should be defined to minimise the risk of error due to misunderstanding of what is being reviewed/approved
Risks with remote approval
Aspects to consider when assessing risk include:
- How the approval signature is attributable to an individual
- Whether there is a legislative requirement or GxP guidance for a signature. If there is, then the signature should be considered more critical and have proportionately greater control – for example when a QP certifies a batch of finished product to enable release for sale
- The security of the electronic signature i.e. so that it can only be applied by the ‘owner’ of that signature
- How the act of ‘signing’ is recorded so that the document cannot be altered or manipulated without invalidating the signature or status of the entry
- Ensuring that all required associated data is available to a remote reviewer that would have been available to them if they were performing the review at a site
Some examples of issues with remote approval are included in Examples of issues with remote approval (PDF, 305KB, 4 pages).
In these examples, had the distribution and approval process been clearly defined and assessed, it is unlikely that these issues would have occurred.
◆ Recommendations for your stability chambers and facility (07-Apr-20 Nagano Science)
We recognize that with the coronavirus (COVID-19) outbreak, there is a possibility that the stability storage facility will be closed by government policy.
In order to prepare for such situation, we recommend to consider following points for your stability testing chamber and data monitoring system. We hope that this will help your continuous stability testing storage.
Daily recommendations before leaving facility
- Check temperature and humidity values displayed on the operation panel. Are the values normal? Are there any error messages displayed on the panel?
- Check the floor and around the water supply. Verify there is no water leakage or any dirt accumulation.
- See the variables of temperature and humidity records displayed on data monitoring system.
- Check the sound of chambers. Is an abnormal sound coming from them?
- Fill up the water supply tank.
Recommendations to make decisions on how to deal with before lockdown
- Figure out how many days it takes to disrupt water supply on average if you are using water supply tank (how often you need to supply water to the tank on average) because water consumption depends on the type of chamber, the condition and the operation conditions.
- Confirm when and how long scheduled water/power outage will occur. Also, confirm if the outage will occur even after the emergency declaration has been imposed.
- Understand that UPS, Uninterruptible Power Supply, for stability chamber and data monitoring system is used for instantaneous power failure.
- Prepare and setup backup data logger for your more important equipment just in case of a power outage.
- Verify the status of refueling and the supply system of the emergency power supply for your lab and facility.
- Set a policy that stability chambers are not opened/closed unnecessarily.
- Clean the water level sensor if any. Depending on the water quality, foreign objects may clog the sensor; therefore, cleaning the water level sensor is recommended in case periodical maintenance can’t be implemented for an extended period.
- Check chambers for clogging of the filter. If foreign objects clog, clean the filter.