Conform.
Produce your products in accordance with GMP.
Sure.
Stand up to any audit.
Ready.
Ready for qualification and validation.
Interested?
How we can support you in GMP / GDP.
- Compliance strategies- GMP- GDP implementation - optimisation
- Implementation of continuous improvement tools and performance metrics
- Risk management & implementation of quality systems
- Quality structures (QC, QA) Capability and personnel assessments
- Inspection readiness master plans (FDA, EU, ANVISA, KFDA, PMDA, TGA and other regulators).
- Trial inspections and support for inspections/re-inspections and "touch-up" work
- Supplier management and monitoring strategies
- Audits: EU GMP EUDRALEX Volume 4 Part I, Part II (ICHQ7) and Annexes, ICH Guidelines, GDP (API and finished medicinal products): SME (small molecules), biologics, vaccines.
- Inspection support (preparation, "war" room presence and live support during the inspection)
- Implementation of training systems / mentoring / coaching
- Training on GMP/GDP compliance and current topics
- Critical incident management support (complaints, deviations, sterility failures, recalls)
- Support for organisational change management in the pharmaceutical industry
- Intelligent CAPA systems - implementation
- Support with the annual product review
- Ensuring sterility (process validation/ aseptic process audits)
- Quality improvement and reduction of non-conformities
Need?
Why not book a QuickCheck?
Case Study.
Analytical / bioanalytical quality control (QC) tests for medicinal products / biologics are a "manufacturing step" and require GMP certification. Expand the scope of analytical / bioanalytical testing to QC of drugs / biologics as a service for drug / biologics manufacturers. QMS certified according to GLP and ISO 17025, but EU GMP regulations cannot be met. Lack of adequate resources with required GMP knowledge as main problem in GMP implementation.
Insufficient prior and internal GMP knowledge necessitates re-creation and updating of existing quality documents to broaden the scope and adopt processes of existing standards to meet GMP compliance and ensure NCA inspection readiness.
Outcome.
- Implementation of an overall GMP-compliant quality management system, processes and standards
- Implementation of an adequate GMP-compliant device qualification process
- Implementation of GMP-compliant method and process validations, efficiency measurements and control systems (in-process controls, IPCs)
- Preparation of the documentation required by EUDRALEX Vol 4, such as the Site Master File (SMF, Part III).
- Achieve EU GMP compliance and National Competent Authority (NCA) inspection readiness.
- Establishment of a comprehensive communication control / communication loop leading to continuous improvements
Become part of the team.
The Entourage is looking for life science professionals.
How we can support your GMP / GDP inspections.
Our global GMP & GDP auditing support:
- 21 CFR Parts 210 and 211
- Eudralex Volume 4
- Due Diligence
- For Cause Audit
- Inspection Readiness
- Mock PAI
- Supplier audit
- Monitoring audit
- 6-System audits (FDA)
- API and DP, NCE & Biologics, Vaccines
- Fill & Finish (sterile solutions)
- Aseptic processing & terminal sterilisation
- ...and execution of remediation measures and works
