Regulatory Inspection Readiness Case Study

Regulatory Inspection Readiness

The Brief:

Lafferty were engaged by one of our clients to program manage the initial inspection readiness activity associated with a new drug product facility located in Ireland. The program involved the start-up of a newly acquired facility consisting of a single use / ready to use multi-format filling line and associated areas.
The scope of services entailed program management, risk management, and governance of the inspection readiness program in order for the site to achieve a successful outcome from their first (HPRA) inspection milestone. The outcome would be to secure the site’s right to operate and first regulatory approval milestone for both commercial and clinical products.

The Approach:

Lafferty was engaged by the Site Leader during the start-up phase of the drug product site to oversee and manage the
site inspection readiness program.

■ Lafferty assumed the role of program manager providing leadership and overall accountability for the inspection readiness program.

■ Lafferty reported out twice weekly at Tier 2 level meetings on progress, hot topics/issues, risk and decisions required. The frequency increased to daily within one month of the inspection week.

■ Lafferty reported out weekly at SLT governance and bi-weekly above site steering meetings.

■ A cross functional inspection readiness team was formed with representatives from quality, operations, engineering, MSAT, and regulatory affairs.

■ Mock inspections with ex-inspectors were arranged and facilitated. The findings from mock inspections transferred
to CAPAs and tracked to closure, including near misses.

■ In-house and third-party SMEs (Quality and ex-Inspectors) were utilised to coach and prepare the site SME’s. Both technical and softer inspection behaviour-based training and coaching was delivered.

■ GEMBA and SLT site walkdowns were conducted with increasing frequency to snag the facility and building
fabric. A facility snag list was maintained and prioritised for closure. Over 400 facility snag items were addressed.
Owners and due dates were agreed and assigned to each action.

■ A sitewide functional gap assessment and cross walk of procedures and quality systems generated a site inspection readiness action log. A ‘burndown’ plan was developed to track the action log to closure. Owners and due dates were agreed and assigned to each action. More than 600 action items were closed.

■ Hot topics – deviation trends, repeat deviations, CQV issues, technical challenges etc. were identified with story boards developed and reviewed with third party and in- house SMEs.

■ A third party specialist was engaged to conduct a data integrity gap assessment across the site which resulted in a remediation plan and associated CAPAs to address gaps identified.

■ Inspection logisitcs and tour routes were identified and prepared in advance of the inspection week. Back- room and IT set-up was tested on dry runs and opening presentation dry runs with SLT.

Program Management

Regulatory Inspection Readiness

The Outcome:

The following outcomes were realised for the client:
■ Clear communications with the SLT aligned on site goals and objectives. Above site alignment with sponsors and key stakeholders.
■ Full site team aligned with clear and regular communications of site goals, objectives, and progress against the same.

■ Clear governance and steering of the site start- up phase – including the various inputs required to drive effective and timely decision making and prioritisation of site activity.
■ Visual reproting of workstream status, hot topics, issues, risks, and decisions required.
■ Risks managed with mitigation assigned to owners and due dates tracked to closure.
■ Functional managers and project managers supported in the delivery of their own objectives, and visibility / accountability driven with respect to the delivery of tech transfer programs to schedule.
■ Successful HPRA site inspection and full site MIA & IMP approal per site annual goals.
■ First commercial products 3 x PPQ batches successfully completed per site annual goals.
■ First clinical product successfully released from site per site annual goals.
■ New capital project management process implemented for site projects.
■ Improved daily mangagement board and process.