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 query. Typical advice includes:
- Expert opinion / advice is required to support decision making in the organisation.
- When ssues arise outside the day-to-day operations and, therefore, an Expert opinion on the best path forward is required.
- When evaluating a decision against Industry best practice.
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Quality Risk Management has been an industry hot topic for several years and the recent Annex 1 revision in addition to the pending ICH Q9 revision, has highlighted the particular focus that regulators place on this element of the Pharmaceutical Quality System. PharmaLex has extensive experience in QRM, having presented several webinars on the topic as well as working with companies to develop, implement, review and update their QRM program.
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QRM programs, when implemented successfully, reduce the workload for an organisation by focusing effort on the areas of highest criticality while also improving compliance, product quality and patient safety. Successful QRM implementation does not require convoluted additional processes that are resource heavy but should focus an organisation on:
- What are the risks and hazards in my process that will impact compliance, product quality and patient safety?
- What is the likelihood that the harm resulting from a hazard will occur?
- What controls are in place to prevent this risk/hazard and are they robust enough?
We provide an expert, bespoke, phased approach for our QRM services and these include:
- Review of the current QRM process or development of a new QRM process
- Development of the plan for implementation of the improved/new QRM Program
- Development of foundational prospective Risk Assessments
- Incorporation of QRM into key Quality Management System (QMS) elements
- QRM Training
With increasing globalisation of pharmaceutical supply chains, the supply chain now often extends across multiple transportation routes and regulatory jurisdictions, presenting specific challenges to the organisation in terms of preserving the quality and integrity of the pharmaceutical product across the supply chain.
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Current regulatory requirements and expectation is that the pharmaceutical organisation has full awareness, control and management of the supply chain from sourcing API and excipients through manufacture of the pharmaceutical product and transportation of the approved medicinal product to the customer via distribution channels. It is expected that each organisation implements the appropriate Quality systems and procedures for assuring quality and compliance of the medicinal product and for preventing falsified medicines from entering the supply chain.
PharmaLex’s team of experts, which includes a number of former EU regulators, provides expert Good Distribution Practice (GDP) support services to our clients including high-level strategic planning and decision making across your pharmaceutical product supply chain.
Our Supply Chain and GDP services include:
- Workshops to understand and identify compliance and regulatory requirements as a result of changing business models in the pharmaceutical supply chain. We work with your Quality, Operations, Supply Chain and Regulatory teams to map the supply chain, including the quality and regulatory compliance roles and responsibilities of your organisation and of your contractors, vendors and third parties involved in the supply chain.
- Developing the Pharmaceutical Management System framework required to manage quality across the supply chain, as per ICH Q10, including the wider responsibilities of the Marketing Authorisation Holder (MAH) such as pharmacovigilance, medical information, promotion and advertising.
- Documenting the required procedures (SOPs) and elements of the QMS framework, that impact the supply chain, including prevention of falsified medicines from entering the supply chain.
- Review of the fiscal framework for the supply chain, ensuring compliance across the supply chain with the relevant wholesale and distribution legislation.
- Development of Supply Chain Maps to reflect physical and financial product flows
- Provision of the required personnel in each of your markets including for example; Responsible Persons (RPs), RP for Import (RPi) and Exploitant services.
Our Team of Consultants include Microbiology experts who have proven expertise in industry.
Our Microbiologists support our clients across all medicinal product platforms, specialising in Biologics and ATMPs where Microbiology expertise is paramount in ensuring product quality and patient safety.
Key areas we support include:
- Contamination Control
- Sterility Assurance
- Cleaning and Disinfection
- Method Validation
- Aseptic Assurance
- Cell Culture
- Coaching and training
- Microbiology Laboratory design and set-up
- Biological Containment
We offer consultancy support to ensure that the planned commercialisation activities of a company are in compliance with all regulatory requirements. Including:
- Quality and Compliance strategy from lab bench to commercial including management of change, data integrity, GLP, distribution and licensing.
- CMO/CRO selection
- Phase appropriate GMP
- QMS Design and Implementation
- Quality Risk Management
- CQV Strategy
- Operational Readiness
Facility Design support: Our team of experts work with Client’s to provide quality oversight of their facility design in collaboration with Architecture and Engineering houses.
PharmaLex experts can assist with the incorporation of QRM into the facility design to ensure that the facility design is optimised to reduce risk and increase efficiency during manufacturing activities.
PharmaLex are well positioned to provide feedback on industry best practice and potential solutions to problems that are inevitably encountered during the start up of a new facility.
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.
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