On 17th of March, 2015, the Medicines and Healthcare Products Regulatory Agency (MHRA) released the newly revised and updated GMP pre-inspection compliance report templates and guidance. The newest format of the report includes guidelines for the inclusion of data integrity policies that will now be added in order for compliance to be met.
Prior to any inspection, entities that fall under the pre-inspection compliance are required to include the following data integrity measures for inspection purposes:
Confirmation that a data integrity / data governance policy is in place.
Confirmation that computerised system owners / personnel with administrative-level permissions are available during the GMP inspection.
Information on the computerised systems that are used for storage, control and processing is available. The MHRA specifically mentions Laboratory Information Management Systems (LIMS) used within Quality Control laboratories in the report in addition to manufacturing execution systems.
A list of all principal computerized systems such as LIMS, ERP and CDS in addition to information on any stand-alone systems and qualification dates.
Entities that deal with manufacturing or distribution of pharmaceuticals will be required to comply with the guidelines for data integrity that have been added to the GMP and GDP process. They will also be required to provide this information if they are a manufacturer that plans to import pharmaceuticals and new entities that are applying for a manufacturing or wholesaler license.
Additional information on the MHRA publication can be found here:
The initial publication by the MHRA outlining the pre-inspection compliance requirements garnered a great deal of interest from stakeholders who had questions regarding what data integrity encompassed. The MHRA released the March report in answer to the question, adding clarification to the text in hopes that the industry will take proactive measures to protect and secure their data instead of reacting or defending their data processes in the event they are audited. By providing industry entities with this information ahead of time, the MHRA is hoping manufacturers and wholesalers will design and operate systems that adhere to the guidelines and product pharmaceuticals that meet the necessary consistency and accountability regulations.
Regulatory requirements are constantly changing, especially when it comes to data integrity. Without accurate information to support a business’ quality practices, the business itself could face fraud charges because of quality violations. Already the FDA and the Department of Justice are investigating numerous international drug maker investigators and clinical trial coordinators because they did not have proper data integrity procedures in place. The MHRA’s push to include data integrity elements in its inspections will help reduce the time and effort that is being put into these investigations.
Pharmaceutical companies, whether wholesalers or manufacturers, are expected to create a Culture of Quality which shows continuous improvement in order to meet the recent changes that have been put into effect in the new regulatory requirement. Data integrity is a fundamental component of any corporation, but especially in a pharmaceutical setting. It helps ensure that the medicines being manufactured and sold are safe and effective for public consumption. A Laboratory Information Management System (LIMS) is one way companies can ensure they are creating a culture of quality and that their data integrity requirements are being met.