FLEXIBILITY
GxP Quality Services
Full-Service Quality Department
While many early-phase sponsors don’t incorporate Quality into their organizational planning, the truth is that there are many regulations that govern conduct from the pre-clinical stage of development all the way through NDA filing, and sponsors need a Quality presence to help ensure compliance. Ciall’s expertise covers all GxP (e.g., GCP, GLP, GMP and GxP Validated Systems), and we partner with clients to serve as their Quality Department in a collaboration that allows access to these GxP experts in a phase-appropriate manner. By incorporating our on-demand quality services before the first clinical study, we help ensure that compliance is incorporated into each step of development to support regulatory filings and allow our clients to show a Quality presence in their organization early on in the clinical development process.
GxP Quality Management System Implementation & Management
Our highly regulated industry requires sponsors to develop and implement a robust, efficient Quality Management System (QMS) that ensures quality, compliance, data integrity, and patient safety.
Our team works with clients to develop a QMS structure that creates the framework to support GxP activities in alignment with the critical responsibilities and activities to be managed internally as well as those outsourced to an external organization.
Elements of this structure include:
Development of phase-appropriate Policies and Standard Operating Procedures (SOPs)
1.
Support for GxP staff training including development of training matrices, rollout of training using our validated, Part 11 compliant Learning Management System, and implementation of staff training folders to ensure required documentation for GxP staff is inspection ready
2.
Implementation of GxP document management processes to ensure critical regulatory documents are held in a controlled environment
3.
Our fit-for-purpose QMS approach preserves the fast-paced entrepreneurial spirit of our clients by providing enough structure to maintain compliance without creating complexity that is unnecessary during the early development phase.
GxP Vendor Audits and Qualification Assessments
Ensuring that partner Vendors are conducting their activities in a manner that is compliant with the applicable regulations as well as their own internal SOPs and sponsor expectations is an important aspect of every clinical development program. Vendor audits are a powerful tool to demonstrate oversight of Vendor activities.
Our Ciall GxP audit team works with clients to create a comprehensive list of contracted Vendors as well as Vendors under consideration, and then develop a risk-based strategy on how to best qualify and provide ongoing oversight of those Vendors. We conduct qualification audits, in process study-specific audits, or for cause audits throughout the life of the project.
GMP Quality Assurance (QA), Quality Control (QC) and Technical Support
Oversight of GMP processes is necessary to ensure clinical products are manufactured, packaged, and released in accordance with global regulatory requirements.
Our Ciall GMP Quality experts provide a full suite of services to support CMC activities including:
Review & Approval of:
Product & Packaging Specifications
Master Batch Records (MBRs)
Test methods (in-process, stability)
Method qualification / validation protocols (Phase appropriate, small molecule, mRNA, proteins)
Executed Batch Records (EBRs) including submission of observations to CMO; follow up and evaluation of responses
Development of QAAs / QTAs
Lot Disposition
Review of CMO OOS / OOE investigations, deviations, and change controls
Stability data analysis and raw data review
Generation of Certificates of Compliance (CoC)
Management of Clinical sample temperature excursions
Support for CMO process-related issues
Assignment of Expiry/retest dates in accordance with ICH Q1