Services

GxP Audit Services

QA audits are crucial to assure that your drug/device development program is conducted scientifically and ethically, in compliance with ICH and national regulations. Proactive audits are key quality tools to demonstrate that your regulatory submissions and marketing applications are compliant with regulatory requirements and expectations from regulatory authorities (GxP). All audits are performed in accordance with ICH, FDA and EMA regulations. GxP Audits include the preparation of specific audit plans, audit visits, audit reporting, audit certificate, and follow-up as needed (e.g. CAPA) in accordance with established SOPs.

All audits are performed either on site or remotely (if documents are made available electronically by the auditee) based on a risk analysis and decision tree. We always try to minimize travel costs and work jointly with our clients to establish the audit strategy and methodology.

We have an extensive experience in the following audits:

• CRO qualification audits (GCP)
• eTMF/TMF audits (GCP)
• Study protocol audits (GCP)
• CSR audits (GCP)
• Investigational Site audits (GCP)
• Commercial IRB audits (GCP)
• SMO audits (GCP)
• Specialized central laboratories (GCP)
• EDC and Data Management/Biostatistics Systems audits (GCP)
• Clinical Database audits (GCP)
• IVRS/IWRS systems audits (GCP)
• Statistics/PK/PD modeling audits (GCP)
• GDPR Subject Data Protection audits (GCP)
• Compassionate Use Project audits (GCP)

• Central Laboratory audits (GLP & GCLP)
• Toxicology in-vivo and in-vitro study audits (GLP)
• Immunogenicity/Carcinogenicity/Pathology/Histopathology study audits (GLP)
• Bioanalytical study (PK/PD) audits (GCLP)
• Biomarker Laboratory audits (GCLP)
• Study Plan/Protocol and Study Report audits (GLP & GCLP)

• CMO qualification audits (GMP)
• API/DS audits (GMP)
• Finished Products/DP audits (GMP)
• Medical Device and IVDD audits (GMP)
• QC Laboratories and method development/validation audits (GMP)
• Primary/Secondary Packaging audits (GMP)
• Distributor/Wholesaler audits (GDP)
• Excipient audits (GMP)
• Batch Records audits (GMP/GDP)

• CRO/PV Service Provider qualification audits (GVP)
• Safety/PV platform and database audits (GVP)
• PSMF audits (GVP)
• SUSAR reporting process/system audits (GVP)
• DSUR/ASR/PSUR audits (GVP)
• RMP/REMS audits (GVP)
• Medical Information Service Provider audits (GVP)

• Computer Systems Validation and Data Center audits (GXP)

Training services

Montrium GXP Consulting provides on-site training allowing significant cost savings compared to off-site training. Standard classroom-taught courses can be provided, or bespoke courses developed around your organizations specific needs. Sessions usually last from half-day courses to full three-day programs. Recent topics that we have covered:

• EU Clinical Trials Directives 2001/20/EC and 2003/20/EC
• EudraVigilance
• Managing clinical trials in the EU
• Managing clinical trials in Canada
• Managing clinical trials in the USA
• Managing clinical trials in Latin America
• Computer Systems Validation
• 21 CFR Part 11 Training
• Auditing Computer Systems used in clinical trials
• General GCP and GLP training
• Training of investigators, study coordinators, and site staff in GCP requirements
• Monitoring Requirements and Sponsor Visits
• Adverse Events, Serious Adverse Events and SUSARs
• Management of eClinical Trials
• Good Clinical Data Management Practice
• Good Laboratory Practice for non-clinical studies
• Audit of Investigational Sites
• Audit of Central Laboratories
• Audit of IRB/IECs
• Methodology for eCTD
• Developing Standard Operating Procedures
• Quality Assurance in Clinical Development
• Quality Assurance in a Microbiology Laboratory

Process Gap Analysis & QMS Implementation

Montrium GXP provides consultancy services to evaluate and map your R&D workflows, systems and processes including clinical development, laboratories and we propose solutions for implementing a fully compliant Quality Management System, standard processes in order to improve efficiency and quality with a clear road-map. Key Performance Indicators can also be implemented to measure the cost of quality.

SOP Development & Review

Montrium GXP offers an SOP writing and review service to assure compliance with the current GxP requirements based on an initial Process Gap Analysis. Montrium GXP can assist in the preparation of SOPs that support the ongoing activities of our clients in addition to providing guidance for the implementation or revision of SOPs and forms to ensure compliance with regulatory requirements.

We can also provide standard templates of SOPs, forms and checklists developed in compliance with ICH guidelines, FDA CFRs, EMA directives, Health Canada regulations and industry standards.

We have experience in implementing and reviewing SOPs for the following: Clinical Operations, Project Management, Clinical Data Management, Pharmacovigilance, Biostatistics, Medical Writing, Regulatory Affairs, Quality Assurance, Information Technology and Computer Systems Validation, Bioanalytical, Method Validation, GLP studies.

Compliance Review of Study Documents

Montrium GXP offers services for the independent QA review of pharmaceutical development records and Essential Documents in accordance with regulatory requirements and SOPs (Client or Montrium GXP).

We have experience reviewing the following documents: Project Management Plans, Study protocols, Investigator’s Brochures, Subject Informed Consent Forms, Clinical Monitoring Plans, Data Management Plans, CRF, SAP, CSR, GLP Reports, Safety Management Plans, SAE narratives, Manufacturing Batch Records, IMP Labels, Stability protocols and reports, Analytical Method Validation protocol and reports, Analytical data versus source documentation, CSV records, etc.

Mock Regulatory Inspections

Mock GCP inspections are the best way to provide a strong training experience that approximates the intensity of a real study inspection. Our Lead Auditors were involved in regulatory inspections (FDA, EMA, Health Canada) as QA escorts. They can prepare the Sponsor’s teams, CROs and clinical sites.

Quality Issue Management

Montrium GXP Specialists can be contacted at any time during the project regarding quality issues and queries about GXP compliance. The Auditors may assist in conducting further investigations, developing action plans or assessing the success of corrective actions taken to address quality issues.