Virtual Standards & Inspections - 8th Edition Insights

8 8th thStandards and Virtual Standards and Virtual Inspections Inspections EIGHTH EDITION 8.0 Stem Cell User Group Meeting 32 21 October 2021 Anne Emmett Quality Manager JACIE Inspector

Standards Standards - - 8 8th th edition published May 2021. edition published May 2021. 16/08/2021 - Effective date of 8th edition. Earliest date for applications to be accepted under the new edition. 31/12/2021 - Final date for sending completed applications to JACIE based on the 7th edition of the FACT-JACIE Standards. All applications after this date must be made under All applications after this date must be made under the 8th edition. the 8th edition. 01/03/2022 - Final date to submit the complete pre-audit documentation under the 7th edition. Any centre that fails to submit all pre-audit documentation by this date will have to restart the application process under the 8th edition of the Standards and submit a new application. Centres already accredited will not have their accreditation affected. For interim audits, centres will be assessed on the same standards as used for the main inspection. However, all centres are expected to adapt their processes and systems to the requirements of the 8th edition.

A new tenet (A2.2) was added to permit flexibility in delegation of specific activities. The term or designee was removed from individual standards throughout. The definition of designee is not changed from the seventh edition. A2.2 Any activity can be delegated to an appropriate designee (as defined). The person appointing a designee retains ultimate responsibility. Some additions to definitions: Genetically modified cell [new definition]: A cell that has been modified by replacing a disease- causing gene with a healthy copy of the gene, inactivating a disease-causing gene that is not functioning properly, or introducing a new or modified gene into the body to help treat a disease. GxP [new definition]: Good practice following various quality standards and regulations. The x is variable, with further definition of good practices defined by different Applicable Law and industry standards. The type of work that is being performed will define which GxPs should be followed. Examples include good manufacturing practice, good documentation practice, good laboratory practice, and others. Standards related to training in these areas were added to Collection and Processing sections.

The addition of GxP has also led to additional training requirements - Addition of training requirements in applicable GxP as required by Applicable Law for Collection and Processing Facilities. (CM3.3.4, C/D4.4.2.5) a. Physicians and collection staff shall have annual training in current GxP appropriate to the processes performed in accordance with Applicable Law. (CM3.3.4) b. Annual training in applicable current GxP appropriate to the processes performed in accordance with Applicable Law. (C4.4.2.5) c. Annual training in applicable current GxP appropriate to the processes performed in accordance with Applicable Law. (D4.4.2.5)

Changes to Processing Facility Standards 1. General. a. These Standards apply to all processing, storage, and distribution activities performed in the Processing Facility on cellular therapy products obtained from living donors. (D1.1)

https://www.ebmt.org/8th-edition-fact-jacie-standards

Virtual Inspections and short form inspections

Short form inspections Participating in the Short Process will require centres to submit quite a high volume of documentation. This will be essential because the inspectors will need to see evidence to assess the Standards by performing a document-based review. In a normal onsite inspection, the centre would already be expected to show these documents onsite and in the absence of an onsite visit, the inspectors require the evidence that will show the centre's compliance. As soon as centres provide the required documentation, an Inspection team will start the revision which will take 4 weeks for those centres that are only desk based. Medium- and high-risk centres will require further focussed inspection. The inspectors' assessments will be documented in an inspection report and presented to the JACIE Accreditation Committee. If any issues are identified, the centre will be required to respond with corrective actions before the accreditation can be awarded. Note that the outcome of the inspection process at any level could require further assessment of the centre where issues of sufficient concern are identified. The Short Process consists of: The Standard set of JACIE pre-audit documentation folders. The Checklist, which has been modified to fit the scope of accreditation of the Short Process, including the removal of the Med-A tap, which is out of the scope of accreditation. An additional set of documentation specific for the Short Process. A video of the facilities to be inspected (optional/required depending on the eligibility of the centre)

Only reaccreditation inspections will be performed remotely. First-time inspections will be scheduled for on-site visits. The process will be largely based on a document review by the inspectors and then a series of online interactions via video- conferencing according to a pre-defined schedule. Technology Microsoft Teams is being set up a platform to support the process. User licences will be prepared by JACIE for inspectors and centres. Centres will be assessed to establish that they can used this technology e.g. file-sharing, video-conferencing.

Documents - a list of documents to be provided by the centre in advance has been prepared. There may be some additional documents not already requested from the applicants. Where documents have already been submitted, those documents that have since been updated should be provided.

Some deferments of re-accreditation inspections has taken place with centres being given a one year extension to their accreditation. Interim (paper) inspections will be continuing as normal - centres should still present documentation focused on quality management aspects. The JACIE office will send them to the inspectors for review. No rest for your QMs.

Any questions?