Valicare GmbH offers a wide range of GMP compliance services
Expertise in customer specific consultancy and detailed knowledge about the international requirements, norm and guidelines like EU-GMP, 21 CFR (FDA), PIC/S, ICH, GAMP5, USP 32 ˂1078˃, EN ISO 9001 and EN ISO 13485 is the basis for excellent support of risk-based GMP project management.
Valicare's GMP experts offers consulting and support-efficiently, pragmatic and professional.
GMP Consulting Service
Broad spectrum of competence
Valicare GmbH employs a team of own consultants who are experienced and have a lot of hands-on expertise in GMP compliance issues. This team has already solved a lot of problems in different areas in pharmaceutical industry, the explanation for the fact, that Valicare solutions are often most suitable for customers realization. The consultants implement guidelines and official requirements in a goal and solution orientated manner always having in mind the practical and economical aspects for your company.
The spectrum of our service portfolio starts with a half day of consulting. Beyond this we offer task orientated project support or permanent long-term compliance consulting for special pharma projects. What we offer depends on your defined needs.
The consultant, who gets in contact with you and later on knows all the conditions and the relevant persons, will be your contact over the whole time of the project. A personal resource you really can rely on.
According to your requirements he/she will work self-dependently making his own proposals or on demand, if customer need personnel resources for execution only.
We are flexible and competence is our business.
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 trainings for almost every topic
Regular training in GMP basics, at least once a year, is an official requirement for each employee of a GMP facility.
Valicare GmbH offers such trainings on a half or one-day basis. The trainings are customized and focused on the products of the customer.
The participants learn what the GMP guidelines demands for their current products and processes thereby allowing a better understanding to each participant. This effect is intensified trough customized training instructions everyone gets before the training.
After an anonymized test everyone will get a GMP training certificate for the successful participation.
Valicare’s consultants have a deep expertise and a broad spectrum to follow up nearly each specific request regarding custom specific training topics.
Already established are trainings for the following subjects:
- GMP basics
- EN ISO 13485 & EN ISO 9001 Compliance
- Riskmanagement and –analysis
- Qualification & Validation
- Validation of methods
- Validation of processes
- Operation and technology of cleanrooms
- GMP requirements for advanced therapy medicinal products (ATMPs)
- Manufacturing license, § 13 AMG
If you have a special training request, don’t hesitate to contact us.
Gap analysis: comparison between Current and target state
Gap analysis is a classic management tool to align the current and target state.
Gap analysis relates either to the entire GMP system or to individual subareas and is an active comparison of the established current state with the requirements specified by local or international GMP regulations. For example, the GMP Guideline Part 1 (Chapter 6 Quality Control) describes the performance and documentation of a gap analysis in the context of analytical method transfers. Other sections include qualification and validation or deviation/change management.
Valicare GmbH has successfully carried out a large number of such gap analyses and offers this consulting service for all GMP systems. If, for example, you are in the process of preparing for an internal, external or upcoming regulatory inspection, we can support you with full commitment and professional expertise by our trained and experienced consultants.
The consultant generally first checks the company-specific documentation and creates a gap analysis plan. Based on the gap analysis plan, the consultant conducts the analysis on site. The results of document and on-site checks are documented and the observations and identified deviations from the target and required state are discussed. All document deficiencies and gaps identified on site, e.g. in production, warehouse or laboratory, are listed separately in the analysis report. The consultant supplements the deficiencies listed in the final report with proposals for appropriate corrective actions and with addressed associated regulations.
A common scope for a gap analysis consists of one consultant day for preparation and for the system dependent on-site analysis (two days for subsystems to five days for the entire site), as well as two additional consultant days for reporting the results.
We would be pleased to arrange an individual procedure for you based on your specific system and questions.
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, Bosch 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.
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.