Guidance

Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak

Guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home

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.

Alternative methods

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.

Further information

Guidance for clinical trials: joint HRA and MHRA statement on seeking consent by electronic methods

We have also published information on arrangements for MHRA Good Practice (GxP) inspections due to coronavirus (COVID-19).

Published 9 April 2020