Quality and GMP Services for R&D
You, your institute or your company, are very successful in developing new solid, semi-solid or liquid dosage forms. You have the ideas, the development processes and the target substances. And you are about to reach the first decisive milestone of your product development, the manufacturing of clinical investigational medicinal products for human use in compliance to Good Manufacturing Practice (GMP.
Your processes now need a design that meets the regulatory requirements in this environment and that can be used to obtain a manufacturing authorization from the regulatory authority in accordance with § 13 of the German Medicines Act, AMG.
On the way from Reseach & Development to the GMP process, the developer is challenged to provide answers to pharmaceutically relevant questions that define the quality of the product:
Answers that you can gather or work out with us. We are Valicare. We have the necessary and applicable process, GMP and documentation expertise to help you meet these requirements. Our team of specialists in Frankfurt am Main – eight engineers and sixteen scientists with PhDs – will be happy to provide the support you need for chemical, pharmaceutical and biopharmaceutical development. We bring your development to GMP level, oriented to national and international guidelines, especially ICH guidelines, EU and cGMP.
Our service offers. You tell us what you need. We talk to you and offer the right service, efficiently, customer- and process-oriented, and product-specific.
Thematic and open consulting services. You tell us what you want to know, and we will offer you a consulting service or training course specifically tailored to your task, the intended manufacturing process or your product.
Our special consulting services tailored to the GMP manufacturing of active pharmaceutical ingredients and medicinal products, the Valicare GMP Services, can be found here.
Plan, lead and drive forward development work. You explain what you want to achieve, we provide project management and control of internal and external development tasks.
Evaluation of process and product requirements. You describe the goals and we show you the risk-based path to a safe and requirement-compliant specified product, accompany you in the necessary target definition of the product-specific quality requirements (quality target product profile, QTPP) and set up the necessary GMP-compliant manufacturing process.
Derivation and definition of characteristic process parameters. You specify the process flow and we guide you in defining and planning the necessary investigations that lead you to a detailed understanding of the process and in defining the critical quality attributes (CQAs), critical process parameters (CPPs) and performance parameters (CPerfPs).
Process control strategy and appropriate limits. You know your process. We support you in defining the control strategy for the critical quality attributes and product specifications and define the parameter corridor (design space) for process control together with you.
Analytics, sampling and quality controls. You specify the process and we guide you in selecting and defining the analytical methods derived from the process control strategy, we describe the correct sampling, and we prepare the documentation required for system suitability, verification or validation.
Manufacturing. You specify the process and we generate the manufacturing instructions and protocols.
Quality control. You specify the methods and we generate the test instructions and protocols.
Batch documentation. You provide the instructions and we create the master batch record (MBR).
Process risk analysis and validation. You specify the process and we accompany you with iterative risk analyses from the entire characterization of the process to the definition and documentation of the required validation activities.
Manufacturing studies and development history. You want to complete the development of your manufacturing process. We compile the results of your own development and the data available in the literature in a professional processed documentation, the overall process development summary.
Process transfer to contract manufacturer. You want to subcontract the manufacturing of your product to a competent contract manufacturer. We offer you the search, the selection and the qualification of a suitable manufacturer. Furthermore, we accompany you in the contract negotiations, in the delimitation of responsibilities and in a securely documented process transfer.
The GMP system. You are aiming for GMP manufacturing yourself. We prepare the necessary GMP documentation for you and write the quality manual handbook (QMH), quality risk management instructions, binding master files, the site master file (SMF), the validation master plan (VMP), and the hygiene master plan (HMP) according to the adapted standard of your industry sector.
Supplier qualification. You want to ensure the pharmaceutical quality of your suppliers. We implement the qualification concept of your GMP system, create the relevant planning and, if required on a risk basis, carry out graduated qualification measures from obtaining certificates to on-site supplier audits.
You want to build a manufacturing plant yourself quickly, inexpensively and in compliance with the authorities. Together with Syntegon, we are the ONE-STOP SHOP for planning, construction, equipment, and ready-to-operate installation of your pilot facility, including all necessary qualification and validation services.
Application for manufacturing authorization according to § 13 AMG. You want to apply for a manufacturing authorization yourself. We will assist you quickly and efficiently in generating the application documents, submitting them in the correct form and communicating with the authorities.
Key pharmaceutical personnel (qualified person, QP; production officer, PO; head of quality control, head QC; head of quality assurance, head QA; head of engineering and maintenance) and start-up of the manufacturing facility under GMP conditions. You need support and management personnel to realize your GMP-compliant manufacturing of investigational medicinal products on time and according to requirements. We help you to find personnel, provide pharmaceutical management functions in a transitional period, if required and available, and manage the GMP-compliant operation of the facility until you take over with your own personnel.
Investigational medicinal product management and investigational medicinal product dossier (IMPD). You are looking for support in the preparation, organization and logistical support of international multi-center clinical studies. We advise you on the selection of study sites, organize the procurement of GMP-compliant placebo and comparator medication, take care of the generation of country-specific documentation and package inserts, carry out packaging, repackaging and blinding processes with suitable advance arrangements, and organize transport including the necessary import/export permits and, if necessary, country-specific approval.
Even after that, we do not leave you on your own. We help you wherever we can with further requirements arising from approval or authorization procedures, in setting up market supply, in organizing logistics and medicinal product transport in cooperation with our market-led partners, and with all other services that you would like us to provide and that we can offer in an industry-safe manner.