Our Services: GMP/GxP Consulting

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 QM 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.

The QMS must cover:
 

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

The quality management system is adapted to the 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 keep you on the safe side. We offer professional support in the implementation of GxP-compliant quality management systems.

You can commission us with the comprehensive conception and document creation for your QMS or have our experts accompany or implement the processing of individual focal points.

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Relevant guidelines:

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)

Key to efficient and error-free operation

GMP concepts describe general procedures for quality assurance tools essential for 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 and much more.

As these documents are the key to an 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.

Two options of GMP concept creation

We offer two different approaches to implement GMP concepts:

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

Get in contact with us now and tell us in which steps of GMP concept development you need support. We will promptly provide you with an offer for consulting services or creation of a concept. Together we find the ideal solutions for your project!

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Review of planned and existing installations

Design review is a well-established GMP consultancy service. 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 play a substantial role in the evaluation process.

Our experienced consultants have already executed countless design reviews in over 20 years.

Design review consultancy in all modes

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

Within Valicare GmbH and through the strong cooperation with our parent company Syntegon comprehensive competencies about classical pharmaceutical and biotechnological production lines also for advanced therapy medicinal products and special pharmaceutical, exist.

Document preparation and presentation

Commonly the design review set up is prepared by one GMP consultant. 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. As a customer, you will receive the report of the discussion. Presentation of the results in front of other corporate representatives is possible on demand.

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Gap analysis: comparison between current and target state

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 definition of the scope to be analyzed is the responsibility of the client. 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 in 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 by 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. Based on this gap analysis plan, the analysis on-site will be conducted.

The results of documents and on-site checks 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 and with addressed associated regulations.

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.

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Temporary assumption of management functions

Most of our natural scientists and engineers are familiar with being in management positions and, if required, also within your company.

Our employees represent expertise and competence in nearly all positions of the 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.

Substitution for a maximum of 12 months

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

As a special service each interim manager has 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 interim manager without a long transition period, if this will be necessary.

Continuity as well as additional availability during capacity intensive business periods is ensured.

Options for charging

Our interim managers 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.

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.

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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.

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 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.

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

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

GxP requirements from R&D to Investigational Medicinal Products

Prior to the introduction of 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 already during development & formulation

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

In case medicinal products shall be manufactured for a clinical trial, a manufacturing authorisation and a corresponding GMP certificate are already required for this purpose.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 have been established, which demonstrates suitable measures to ensure the proper quality and safety of the medicinal products according to EU standards.

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

We offer full services along the entire product life cycle:

1. GMP in Research & Development

• 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 the preparation of the corresponding documentation
• Validation of processes, methods, systems and transport management procedures
   
• Creation of hygiene concept 
• Scientific Advice
• Support in the selection of key personnel
• Training of employees 
   
• 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 the inspection and
• Support during the 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 authorisation: according to § 13 (1) of the German Medicines Act; for the import authorisation: 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}