GMP/GxP consulting

Competent GMP consulting is one of the outstanding strenghts of Valicare GmbH

A team of permanent consultants, specialized in various fields of competence, supports our customers in the GMP-regulated industry in their tasks and problems with expertise and foresight.

Our experts are addressing professionally and efficiently your various and demanding GMP requirements.

We are able to offer individual niche solutions for your challenges as well as comprehensive packages that cover all your GMP requirements. For start-ups, we provide the implementation of a quality management system with all mandatory documents (GMP & GDP). Furthermore, our team support the GMP-compliant definition of your process steps and implementation with regard to rooms and equipment (GxP QMS, GAP Analysis, Qualification & Validation). With us, you obtain your manufacturing authorization and the corresponding GMP certificate within the shortest possible time and move your business idea forward as quickly as possible.

We implement the corresponding GMP-related measures quickly, reliable and professional if your processes, plants, premises, equipment or products need to be changed. The scope of our GMP services depends on the project scope: half-consulting days for small projects but also several months for extensive projects.

Your main contact person will support you throughout the entire project and might involve ad-ditional internal teams as appropriate for the activities in question.

  • GxP QMS

    GXP-COMPLIANT QUALITY MANAGEMENT SYSTEMS: KEY TO EFFICIENT AND FAULTLESS OPERATION

    Ensure the quality of your products by setting up a QMS. Valicare's experts will support you with consulting, document preparation & implementation.

    To ensure the proper quality of pharmaceutical and biotechnological products, numerous sets of rules of Good Practices (GxP), have been published. They cover a wide range of areas to ensure the safety of medicinal products, such as:

    • Good Manufacturing Practices (GMP)
    • Good Clinical Practice (GCP)
    • Good Laboratory Practice (GLP)
    • Good Distribution Practice (GDP)

    All these regulations require a dedicated quality management system for the respective companies. This must cover on the one hand general quality assurance measures, such as training or self-inspection, and on the other hand very individual procedural instructions for the company-specific activities.

    Standard Operating Procedures (SOPs) as well as all supplementary quality management documents (QMS) should be optimally tailored to each other and to the company's organization in order to enable efficient and faultless work in accordance with the respective rules.

    The relevant supervisory authority checks the legally compliant design of your QMS and can only grant your company a permission for the activity in question if all processes are described in compliance with the regulations.

    Valicare GmbH provides professional support to create and implement your GxP-compliant quality management system!

    We can offer the complete set-up and creation of documents for your QMS as well as the focus on certain specified tasks.

    GMP: Good manufacturing practice | European Medicines Agency (europa.eu)
    GCP: ICH E6 (R2) Good clinical practice | European Medicines Agency (europa.eu)
    GLP: Good laboratory practice compliance | European Medicines Agency (europa.eu)
    GDP: Good distribution practice | European Medicines Agency (europa.eu)

  • GMP Concept

    Key to efficient and error-free operation

    GMP concepts describe general procedures for quality assurance tools essential for operation of a GMP system and thereby confirm, that product and processes are compliant to the guidelines and regulatory requirements.

    This comprises a multitude of documents like work instructions, standard operating procedures, concepts for training, qualification, validation, deviation and change control management, handling of OOS results, self-inspections and much more.

    As these documents assure efficient and error free operation of the GMP unit, they should fit to each other and to the size of the customer side.

     An essential prerequisite for the efficient and practical application of the quality assurance tools is the deep knowledge about options and variation. This and the exact description of the requirements and processes allows the adequate adaption of the tools to the real need of your GMP system.

    The Valicare GmbH offers support for implementation of GMP concepts as a pure consulting service whereat our experts evaluate the situation and based on this give advices to the customer only.

    On the other hand Valicare GmbH provides extensive preparation of instructions for each quality assurance tool required for this GMP unit.

  • GMP-Design Review

    Review of planned and existing installations

    Design review is a well-established consultancy service of Valicare GmbH. By this procedure planned or already built technical equipment and installations are approved on quality by design criteria, suitability and GMP compliance.

    The normal scope of a design review could range from viewing a single room or a whole facility. Besides GMP compliance the production capacity and customers product spectrum is important for the evaluation and will obviously be in focus of the executing consultant.

    Valicare’s consultant team has already executed a multitude of design reviews and can offer this consulting service in each mode usual in the market.

    For design review detailed technical documentation about the equipment and installations are required. An on-site presence of our consultants is mostly not necessary or needed.

    Within Valicare GmbH and through the strong obligation to our mother, Syntegon Packaging Technology GmbH, comprehensive competencies about classical pharmaceutical and biotechnological production lines also for advanced therapy medicinal products and special drugs, exist.

    Commonly the design review set up is prepared by one person. The documents then are checked and evaluated in presentation mode by two or three experts. In a protocol or a report of that discussion customer will get detailed descriptions of any inconsistencies or deviations observed.

    Also the provided technical and organizational concepts were followed and scrutinized on the basis of known or defined process parameters.

    All discussions will be closed results-orientated and all issues will be evaluated and documented in detail. Customer will get the report of the discussion meeting and a presentation of the results on demand.

  • Gap Analysis

    Comparison of actual and target

    Gap analysis is the most prominent consultancy service in our regular GMP compliance portfolio. The normal scope of gap analysis is either customers whole GMP system or specified part of it (like for example qualification, validation, deviation or change control management). Our consultants check the current status of your system in place, whether it fulfills GMP requirements and define resulting gaps and measures.

    The Valicare GmbH has already executed many different gap analyses and offers this service in each variation usually needed on the market.

    After screening of relevant documents of the company a gap analysis plan for on-site execution is scheduled. All results are documented and each deviation to the target state is discussed. A summary about all deviations to GMP compliance is prepared and documented in the final report together with proposals for corrective action.

    For such a project Valicare GmbH regularly needs one day for preparation, two to five days for analysis on-site (depending on the size of the system) and two additional consulting days for reporting and documentation.

    Usually we can do analysis on your request promptly because we have our own flexible consulting team.

    So even if support is needed short-term, don’t hesitate to contact us.

  • Interimsmanagement

    Temporary assumption of management functions

    Most of our natural scientists and engineers are familiar with being in management positions and instruct project teams regardless whether the current exercise is located inside Valicare’s or customer’s organization.

    Our employees represent expertise and competence in nearly all positions of the quality management functions like for example quality management representative, qualification & validation manager, GMP training manager, etc..

    If you need personnel compensation for example for parental leave or for other short-term vacancies, our competent interims managers will support you for up to 12 month, limited to leadership positions only.

    As a special service each interims manger has a personnel back up at Valicare GmbH office, who is well-informed about the current situation at the customer-site, so that he or she can replace the interims manager without a long transition period, if this will be necessary. Continuity as well as additional availability during capacity intensive business periods is ensured.

    Our interims manager are very flexible and their work is charged on hourly basis only. A fixed price offer including all incidentals can be submitted on special request.

    If you need compensation of a quality management function independent whether short- or long-term, contact us please and let us check for a suitable profile.

  • Supplier qualification

    The good manufacturing practice environment requires  qualification of suppliers to ensure drug quality and safety.

     

    The EU GMP Guidelines as well as ICH Q10 and the national AMWHV (German Ordinance for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients, Arzneimittel- und Wirkstoffherstellungsverordnung) specify requirements for assuring quality of the product between the customer and contractor or supplier. In addition to suppliers of goods (manufacturers and intermediaries of starting materials, active ingredients and excipients; contract manufacturers of intermediate and finished products, packaging materials, plants, systems, spare parts, computer systems etc.), suppliers of services (with regard to calibration, maintenance, repair, pest control, storage, logistics, transport, distribution, development, manufacturing, testing, release, archiving, cleaning, clothing, consulting, third-party audits, etc.) must also be assessed in this context.

    The aim of supplier qualification is, on the one hand, to safeguard supply chains throughout the product lifecycle and, on the other hand, to ensure robust internal processes in compliance with the relevant regulatory requirements.

    Supplier qualifications are risk-based, with the scope and depth of the assessment depending on the process-specific risk level.

    As part of risk management and on the basis of regulatory requirements, audits must be carried out by adequately trained personnel from the manufacturer or by third parties on site at the supplier's premises or by means of questionnaire audits, depending on the criticality of the goods/services. Furthermore, already qualified suppliers must be regularly re-evaluated or requalified.

    Assured supply chain with qualified suppliers and robust processes is ultimately the basis for reducing complaints and ensuring medicinal product safety.

    Thus, all supplier qualification actions contribute to the overall goals of medicinal product safety, efficiency and compliance.

    Regulations:
    AMWHV
    EU GMP Guideline, Parts I and II
    CH Q10 Pharmaceutical Quality System

We are there for you

Contact us if you have any questions. We will gladly answer and advise you.

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