Consulting

We offer our support for any up-grade project, new installation, or independent reviews at your facility and we help you to achieve “time to market” goals. 

Valicare consultants offer specific support in the following areas of services: 

• Preparation of (c-) GMP compliant systems and procedures for your Quality Assurance System, including the required GMP compliant documentation, and your Quality Control department (microbiological and chemical laboratories). 
• Qualification of manufacturing of all pharmaceutical dosage forms (liquid, solid), of active pharmaceutical ingredients (API), Medical Devices, compounding, filling, and secondary packaging. 
• Your qualification / validation concept for new and for existing (old) equipment including risk analysis for systems and processes. 
• Technical Review of your equipment for GMP compliance and validatability. 
• GMP Review of your computer systems and assessment of critical data management like electronic batch records and recipe management. 
• Verification and preparation of GMP compliant lay-outs for personnel and material flow in your manufacturing and quality control areas. 
• Training of your personnel from Manufacturing, Quality Control, and Quality Assurance concerning GMP requirements and preparation for an inspection. 
• Support in treatment of GMP observations after an inspection. (e.g. “483” of FDA) 
• Support in method and process transfer concepts for rapid, GMP compliant introduction of requirements and specifications from Research and Development into routine manufacturing processes.

Valicare can start with an initial audit and clarify the scope of your project, your required time-lines, and define the responsibilities of the resources needed – either with your own personnel or independently - as necessary.