Our GxP Audit Service Area focuses on Vendor Program Management and Inspection Readiness. Our Team of technical experts work with our clients providing strategic and tactical advice to assist our clients to comply with their regulatory obligation. PharmaLex has pioneered Virtual Audits in the COVID-19 era and has become industry leaders, having completed both routine and highly technical mock Pre-Approval Inspections using virtual methods.
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Confidence Beyond Compliance
Ensuring your internal systems, or those of your supplier or client meet the necessary requirements, is essential before undertaking any regulatory process. It is also pertinent to follow good practice (GxP) guidelines in order to satisfy the regulators that all aspects meet their standards.
A functional pharmaceutical quality system is not only a regulatory requirement, but also an integral element in pharmaceutical organizations to assure products’ pharmaceutical quality and patients’ safety. A well designed and efficient quality system will serve as a safe and sound basis for your business. It documents and verifies your approach for high quality products towards health agencies.
We offer advice, guidance and solutions in the following areas:
- Providing consultancy, gap analyses and operative support on GxP topics
- Designing, implementing and optimizing your GxP quality system
Preparing applications for manufacturing and wholesaling authorizations
- Designing and documenting processes as SOPs
- Implementing risk management approaches / FMEA analyses
- Planning and performing GxP audits and self-inspections
(incl. CAPA management)
- Preparing and supporting health agency inspections
- Supporting remediation activities
Vendor/Supplier Program Management/ Supplier Qualification and Audits
Each organisation is responsible for ensuring their vendors provide consistent quality of services and materials which are fit for purpose throughout the product lifecycle.
Vendor management is the process of working with vendors, controlling costs and increasing value whilst ensuring quality and managing mitigating risks.
Selecting the right vendor and periodic evaluation of the vendor is a critical stage in the product lifecycle to ensure consumer demands for high quality products are met while also meeting high regulatory standards.
Some key elements required to support a vendor management programme include:
Technical support for issues management PharmaLex can support all aspects of vendor/supplier management, including:
- Application of QRM to Supplier Qualification and Management
- Development of a risk-based audit schedule
- Management and execution of the audit programme
- Development of vendor/supplier metrics
- Development of Quality Technical Agreements (QTAs)
- Oversight or management of audit follow-up, e.g. CAPA management
- Technical support for management of vendor/supplier issues
- Identification of vendors/suppliers for dual sourcing
Maintaining regulatory compliance across the product lifecycle is critical for ensuring the continuity of a client’s operations. Whether the organization is virtual or fully in-house, auditing is a mandatory component of maintaining regulatory compliance.
PharmaLex has a team of expert GxP consultants (including ex-regulators) from a wide variety of backgrounds who can perform audits in compliance with global GxP regulations, ICH guidance, PIC/S, ASTM, ISO standards and best practice. This allows for maximum flexibility to provide technically suitable and centrally located auditors for each audit when needed.
PharmaLex Auditors provide peace of mind for each audit; they are responsible for all audit preparation, audit execution, and audit reporting. Following the Audit, PharmaLex can support post-Audit activities such as CAPA management and remediation activities to closure.
Our QMC team has the breadth and depth of experience to conduct all audit types, including:
- Third-Party audits
- “For cause” audits
- Mock inspection / PAI Readiness
- QP Audits for QP Declaration
- Data Integrity Audits
- CMO/CLO/CRO Selection Audits
- Audit coaching and training
All product types, including:
- ATMP & ATIMP
- IMP and Commercial
- Small and large molecule
- All dosage forms, incl. OSD, liquids, creams, DPI, parenterals
- High containment, cytotoxic, high-potency
- Medical Devices
All provider types, including:
- Finished Product
- GDP / Supply Chain
- MAH (e.g., labelling, artwork, data management, dossier compliance, marketing compliance etc)
Most companies are aware of the importance of being “inspection ready” at all times and have inspection readiness programmes built into their Quality Management Systems.
PharmaLex can perform a Mock Inspection to prepare organisations, both virtually and in-house, for regulatory inspections in many of the major pharmaceutical and medical device markets including USA, Canada, South America, Europe, and Asia. A Mock Inspection is particularly important to test your readiness as part of your MIA/WDA/MAA application process in Europe and equivalent licensing in other markets e.g. Establishment Licence.
The Mock Inspection will review the Client’s Facility, Process and Quality Management System as it currently stands and compare it with the relevant regulatory guidelines, current legislation and industry best practice.
These Mock Inspections are conducted using a “hat-on/hat-off” approach in which the Auditor provides feedback to the Auditee during the Audit. This real-time mentoring improves Auditee performance, preparedness and confidence for upcoming inspections.
Following the Mock Inspection, we will provide recommendations on the remediation actions to be taken prior to any regulatory inspection and support the implementation of the recommendations if required.
We offer global solutions covering the entire product lifecycle
Our solutions, consisting of core services, which are tailored to address each of your unique requirements. Extensive program management expertise is a key success factor within our service solutions.
Commissioning, Qualification and Validation
We have been providing Commissioning, Qualification, and Validation (CQV) services to our clients for over 18 years. Our dedicated CQV professionals bring a depth of knowledge across the entire validation lifecycle (VLC), having supported clients from all major sectors within the Life Sciences industry. We guide our clients in the selection of the right CQV strategy and fully support all deliverables, from protocol preparation, through “on the floor executions” data analysis and Report preparation.More Info
GxP Technical Consulting
Our GxP Technical Consulting Service provides access to our international Consulting Team, including a number of former EU and US Regulators, with expertise across the entire product lifecycle, ensuring that the broad Regulatory perspective is factored into the detailed consideration of your queryMore Info
Quality Systems and Compliance
PharmaLex can provide support with PQS planning, development and implementation. We can also remediate PQS that are not working properly and we can also provide support with the implementation or remediation of specific elements of the PQS such as Supplier management, Quality Risk Management, Change Management, Learning Management and deviation management to name a few. We can design and implement PQS for MIA, WDA and MAH.More Info
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