Achieve your goals quickly and safely with our GMP consultans

Ensure the quality of your products by setting up a QMS. Your Valicare experts will support you with QM consulting, document preparation, and implementation.

To ensure the proper quality of pharmaceutical and biotechnological products, numerous sets of rules of Good Practices (GxP) have been published:

• 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.

The QMS must cover:

• General quality assurance measures (e.g. training or self-inspection)
• Individual procedural instructions for company-specific activities

The quality management system is adapted to each company

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 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.

Professional support to create and implement your GxP-compliant QMS

Our GMP/GxP experts offer professional support in the implementation of GxP-compliant quality management systems.

Ask us for a comprehensive conception and document creation for your QMS or have our experts accompany or implement the processing of individual focal points.

GMP concepts describe general procedures for quality assurance tools essential for the operation of a GMP system.

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, etc.

As these documents are the key to an efficient and error-free operation of the GMP unit, they should match and fit your customer's size. An essential prerequisite for the efficient and practical application of the quality assurance tools is a deep knowledge about options and variations.

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.

Two options of GMP concept creation

We offer two different approaches to implement GMP concepts:

1. Consulting service: Our consultant evaluates your individual case and provides you with an expert assessment.
2. Extensive preparation of instructions: Our experts create comprehensive instructions for all necessary quality assurance tools.

Contact us now and let us know where you need support during your GMP concept development. We will provide you with an offer for consulting services or creation of a concept promptly.

Design review is a well-established GMP consultancy service. With 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 can range from checking a single room to examining a whole facility. Besides GMP compliance, production capacity and the customer product spectrum play a substantial role in the evaluation process.

Our experienced consultants have already executed countless design reviews.

Or design review offering – the full portfolio

We can offer you this consulting service in each market-usual mode. The design review can often be carried out without on-site presence, based on the technical documentation on the general and detailed planning of an installation.

Valicare and our parent company Syntegon have comprehensive knowledge in classical pharmaceutical and biotechnological production lines also for advanced therapy medicinal products and special pharmaceuticals.

Document preparation and presentation

The design review is usually prepared by a GMP consultant and checked by two or three experts.

The protocol or report provides you with detailed descriptions of any inconsistencies or deviations observed. The provided technical and organizational concepts were evaluated on the basis of known or defined process parameters.

All discussions are results-orientated, and all issues are evaluated and documented in detail. You will, of course, receive the report of the discussion. A presentation of the results in front of other corporate representatives is possible on demand.

"GMP Layout Review" for planning new or existing systems

New construction plans or even the reallocation or change of use of a pharmaceutical plant is often the reason for a layout review.

In most cases, the customer's request relates to production areas, but warehouses or laboratories can also be included. 

The GMP layout review is part of the classic design review, which is understood as a documented and systematic analysis of a pharmaceutical plant or equipment design according to GMP requirements. The target is to confirm the GMP compliance of the design or to identify existing violations and gaps and define corrective solutions. 

The Focus of GMP Layout Review

As part of the GMP layout review, the following topics are considered based on GMP requirements and target-oriented suitability: 

• Material/personnel flows
• Room layout (incoming/outgoing goods, airlock concept, production rooms, quality control, storage)
• Room pressure concept
• HVAC system

• Utility/Media supply  
• Equipment

GMP compliance check on document basis and on-site

SOPs, documents, basic concepts (e.g., hygiene) and the QA system can also be part of the review which is initially carried out on a document basis. If an on-site assessment is required, this can be included at the customer's request.

The assessment of the current planning status according to GMP aspects and the state of the art will be summarized in a review report with proposed measures to improve or ensure GMP compliance.

Are you planning a new plant or the improvement of an existing plant and want to assure that it fulfills GMP requirements? 

Then let your GMP layout created or checked by our experienced GMP consultants and technically skilled experts. Knowing what is important, saves time and effort.

The Gap analysis is a classical consulting tool to align the current with the target status. It relates either to the entire GMP system of a regulated company or to individual subareas.

This includes for example, qualification, validation, and deviation or change management. The Gap analysis is an active comparison of the established current state with the requirements specified by local or international GMP regulations.

The client is responsible for defining the scope to be analyzed. In case of comprehensive gap analyses, the GMP/GxP consultant performing the analysis may recommend clarification of interfaces or transitions between individual analyses.

More than 20 years of experience in gap analysis

Our team of experts has successfully carried out many gap analyses over the last 20 years and offers this consulting service for all GMP systems.

If 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 from our trained and experienced consultants.

This is what a typical procedure looks like: the GMP consultant first checks the company-specific documentation and creates a gap analysis plan, on the basis of which the on-site analysis is conducted.

The results are documented and the observations and identified deviations concerning GMP requirements are discussed. On the last day of the analysis period, the consultant supplements the deficiencies listed in the final report with proposals for appropriate corrective actions.

The standard time frame for this service is as follows:

• 1 consultant day for preparation
• 2-5 days on-site analysis (depending on the system)
• 2 additional consultant days for reporting the results

Thanks to our extensive team of consultants, we are usually able to carry out the requested gap analysis in a timely manner.

Most of our natural scientists and engineers are accustomed to management positions and will also assume them in your company.

Our employees have the expertise and competence in nearly all quality management functions (quality management representative, qualification & validation manager, GMP training manager, etc.).

Whether you need personnel compensation for parental leave or for other short-term vacancies – we offer you the right interim manager for every requirement profile.

We generally limit this service to a maximum of 12 months and only take over leadership positions where our employees contribute their expertise and dedication.

Do you currently have a requirement and need to fill a leadership position on an interim basis? Ask us about suitable profiles for your temporary vacancy.

The EU GMP Guidelines as well as ICH Q10 and the German AMWHV specify requirements for assuring quality of the product between customers and contractors or suppliers.

This applies 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.

The most important goal: securing supply chains

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 chains, robust processes

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

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

Do you need support or advice on supplier qualification? Contact us. Together we find the best possible solution.

Relevant regulations:
AMWHV
EU GMP Guideline, Parts I and II
ICH Q10 Pharmaceutical Quality System

Prior to the introducing medicinal products to the market, the regulations of Good Practice (GxP) have to be followed during production and development.

These include Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Distribution Practice (GDP).

During the product life cycle of a medicinal product, quality requirements increase continuously from research and development through the different clinical phases to market maturity.

GMP-relevant topics during development and formulation

The first compliance measures for Good Manufacturing Practice (GMP) must already be implemented during development and formulation. They basically include all GMP-relevant topics which are to be applied on a risk-based approach according to the respective development stage.

If medicinal products are to be manufactured for a clinical trial, a manufacturing authorization and a corresponding GMP certificate are already required.¹

Upon request, the respective regulatory authority will conduct an on-site inspection to verify compliance with national law and EU GMP requirements.

Quality management system for description of internal processes

Prior to this, an appropriate quality management system must be established, which demonstrates suitable measures to ensure the proper quality and safety of the medicinal products according to EU standards.

The following aspects must be documented and ensured: description of internal processes, suitability of all premises and facilities, conformity of materials used, staff qualification, and quality of external services.

We offer full services along the entire product life cycle:

1. GMP in R&D

• Development of GMP-compliant processes and methods (incl. CPP and CQA)
• Definition, description, adaptation, and verification of QC test methods
• Special services for ATMPs

2. GMP for manufacturing of investigational medicinal products,

including the relevant application to obtain or extend your authorization/GMP certificate (according to § 13 or § 72 AMG):

• Generation of the Site Master File
• Preparation of Standard Operating Procedures (SOPs) and related forms 
• Qualification of premises, facilities, and equipment as well as preparation of corresponding documentation
• Validation of processes, methods, systems, and transport management procedures

• Creation of hygiene concept
• Scientific advice
• Support in the selection of key personnel
• Employee training

• Identification, selection, and qualification of external service providers
• Audits and contractual agreements for external services (e.g., suppliers, analysis, transport)
• Audits to prepare the QP declaration for the import of products into the EU
• Investigational product-specific requirements: labelling, provision through just-in-time processes, return shipments, and destruction

• Mock inspection: in preparation for inspection
• Consulting scale-up/scale-out and automation processes
• Special GMP services for ATMPs

3. GDP for investigational medicinal products

• Logistics for clinical supplies: storage distribution
• Support in procurement of comparator medication
• Supply chain optimization

Do you need support or advice on one or more of these topics? Our experienced professionals will accelerate the entry of your product into the pharmaceutical/biotech market.

^{1 for the manufacturing authorization: according to § 13 (1) of the German Medicines Act; for the import authorization: according to § 72 of the German Medicines Act; format according to: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/basicformat_manufacturersauthorisation_en.pdf}