The QualiCeutics Group has worked with multiple clients to help prepare their CMO/CROs for Pre-Approval Inspections (PAIs).   Multiple mock inspections were performed of contractors located in the US, Europe, and Asia.  In most cases, these are 2 – 4 day mock sessions to help client and contractor identify any potential gaps prior to a visit by the health authority.

For one client, there was a concern of inspection-readiness related to data integrity practices.  These mock inspections were focused on challenges to recently remediated data integrity controls.

A large, generic Indian drug manufacturer was under regulatory scrutiny for poor investigation and laboratory practices. Consultants from QualiCeutics joined others to perform a retrospective review of past OOS investigations and chromatographic test results.

The OOS retrospective review of manufacturing and laboratory investigations was led by QualiCeutics, who managed multiple consultant resources. The project was successfully delivered in less than 30 days and included over 200 formal retrospective reviews, along with a final summary report to the client.

QualiCeutics joined other consultants to help implement a site-wide Quality Improvement initiative for a European pharma client. For this project, QualiCeutics was specifically brought in to formally assess the Data Integrity processes and practices related to all stand-alone computerized Lab Systems within the QC department.

Over a period of several months, practices related to the generation, modification, security, traceability, and storage of electronic records and signatures were reviewed for more than 25 instrument types. Findings and recommendations for remediation, based on compliance with EU and US regulations, were detailed in a final report to the client.

A global manufacturer of sterile injectables operating under an FDA Warning Letter was in need of an upgrade to their antiquated LIMS system. The client chose to upgrade to ThermoFisher’s latest SampleManager LIMS version. The initial phase of the project planning had been over simplified, suffering from minimal user requirements and process mapping. The implementation was also complicated by the addition of new functional modules, including Environmental Monitoring.

The QualiCeutics Group was chosen to lead the second phase of the project. Working with a team of Subject Matter Experts, QualiCeutics successfully re-built the project plan, re-focused the team and lead the project through the qualification phase.

As part of a larger remediation effort, QualiCeutics was chosen to lead a workstream tasked with re-engineering a Quality Control training program. The program had to support approximately 125 staff members, and no formal training material existed at the time.

A new curriculum was developed to support multiple roles and new processes were implemented and integrated within the client’s local Learning Management Systems (LMS). The effort included the creation of more than 30 QC training courses, with each course containing an instruction guide, a student guide and a skill assessment form. Modules ranged from basic lab practices, such as performing pH measurements, to more complex skills like chromatographic review techniques. Responsibilities also included the delivery of classroom training sessions without impact to productivity, which QualiCeutics was able to deliver.