Contact

Hanny Nelis

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Hanny Nelis
BSc – Managing Consultant

Hanny Nelis started in 1980 as Clinical Laboratory technician. As head technician in Blood Bank Leiden she had her first experiences with GMP. From there Hanny joined Xendo in 1993. Since 2007 Hanny is the manager of the team Healthcare that primarily focuses on healthcare organizations like hospital pharmacies, laboratories and blood banks. Hanny is accustomed to work in this environment that needs a specific approach due to the relative small organizations, diverse services and products and limited budgets.

Hanny has a lot of experience with the implementation of quality systems, like ISO, GMP and GMP-z. This includes performing audits, base line inspections, hands-on assistance with generating procedures, formulating policies, giving training, etc. Since the mid-90’s the validation of automated systems with GAMP has become one of her main topics.

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Qualification and validation are regulatory requirements as well as being good business practices. To demonstrate the suitability of your processes and equipment for their intended use, with acceptable resources, timelines and costs, we can offer you seasoned professionals with a hands-on mentality that have extensive experience working at companies such as yours.

  • Planning the implementation of systems
  • Writing requirements, specifications, and test protocols
  • Auditing or accessing/selecting suppliers
  • Executing risk assessments
  • Installation and configuration witnessing
  • Performing validation and qualification tasks
  • Operational procedures
  • Decommissioning/phasing out

Design & Execution of Validation Master Plans

Our industry experts help you define the outlines of your Validation Master Plan, which can be considered to be the groundwork for a GMP facility. The FDA, EMA and Notified Bodies will most likely examine this document when evaluating your validation processes during one of their inspections. The document includes the entire facility, from its utilities and equipment to the various (computerised) systems that may need to be validated.

Our consultants provide you with a well-documented and robust programme to achieve and maintain your qualified facility, while adopting a risk-based approach to the design of your VMP.

Process & Product Validation

From the design stage through to product manufacturing, data collection and evaluation are a requirement for process and product validation as recorded in Good Manufacturing Processes for pharmaceuticals (21 CFR 211), biotech (21CFR 600) and medical devices (21 CFR 820) as well as in the European regulations.

Validation is one of Xendo’s core activities and we help you ensure that your processes are proven to be consistent and capable of delivering a high-quality product.

Computerised Systems Validation & Data Integrity

Computerised Systems and the data they produce and/or process are subject to GMP. The inspectors of the various authorities are focusing increasingly on their validation; inspection readiness scans and validation are effective ways of demonstrating efficiency and compliance.

Thanks to our approach based on the globally accepted GAMP 5 guideline and the ISO62304 European harmonised standard for medical device software, we have the expertise and the capacity to assist you. We take the entire life cycle of your system into account, from design, procurement, installation, configuration and validation up to and including the operational maintenance of various systems.

Computerised Systems Validation & Data Integrity

Analytical Method Validation

The need to validate analytical methods is clear and is a requirement in most regulations (ISO13485, cGMP & GLP) for quality control laboratories. As an integral part of your quality system, it goes hand in hand with the qualification of instruments and the use of system suitability testing.

Our consultants help determine that your methods are suited to their particular purpose and achieve valid analytical test results using the required laboratory tests as defined by the various agency working groups.

Cleaning Validation

The reliable cleaning of your processes and equipment is mandatory in order to prevent the possible cross-contamination of residues, cleaning aids or microbial components and ensure product quality and safety. During inspections, the agencies require a series of well-documented reports issuing from cleaning validation studies in order to be assured that manufacturing is taking place in accordance with pre-defined quality standards in terms of the cleanliness of your processes and equipment.

Our consultants help you develop a justifiable rationale as well as a strategy and instructions geared to your manufacturing site and enable you to demonstrate compliance with the applicable regulations.

Qualification of facilities, utilities & equipment

In your Life Science facilities, all of the above mentioned tasks are subject to strict qualification processes involving Design Qualification (DQ), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Requalification (RQ) to ensure they are all well-suited for GMP use.

Our team of engineers, pharmacists and validation and QA specialists is experienced in defining User Requirement Specifications, setting up design qualifications and reviews, conducting Factory & Site Acceptance Tests, and performing Installation / Operation & Performance Qualifications. They work their way through the V-Model and adopt a risk-based approach.

Furthermore, our team of validation engineers conducts hands-on validation measurements for:

  • Sterilisation Processes
  • Temperature distribution
    • Warehousing
    • Logistics
    • Equipment
  • Medical gas quality
  • Cleanroom, class A-D (According to NEN-ISO 14644 and VCCN Guideline 7(the Dutch guideline for operating rooms)
    • Air flow
    • Filter integrity
    • Particle count
    • Microbial testing

V-Model

Qualification of Medical Gas systems

Past events have prompted the Dutch Health Inspectorate (IGZ) to tighten its regime with regard to inspecting the production and distribution of medical gasses in hospitals. Problems are regularly encountered in relation to unclear responsibilities, quality management system deficiencies or the absence of such a system, the absence of a dedicated outlet, and the lack of oxygen shut-off valves in treatment rooms.

If you do not have the requisite resources, capacity or knowledge in-house, our consultants can help you set up your QMS or other procedures, or provide you with consultancy services in specific areas that need to be improved.