Planning and Consulting

Pharma Planning

Basic and Detail Planning for

  • Pharma Water Systems
  • Clean Rooms
  • Laminar-Flow Plants
  • New Constructions, Rebuilding and Enlargement
  • Stem Cell Laboratories


Pharma Consulting

Outstanding Competence in
 

  • Quality Management Systems
  • Validation
  • Qualification, Calibration, Documentation
  • Technical Auditing
  • Maintenance and Repair
  • Personnel Training
All our service aims at efficiency, security of function and operation, and acceptance by the authorities. It fully corresponds to the current GMP guidelines of EU, FDA, PIC, and WHO
 



Planning of Pharma Factories and Pharma Projects

for the sterile production of parenteralia, zytostatica, liquida, ointments, cremes. The planning extent includes complete turn-key factories as well as rebuilding and modernisation, capacity extension and enlargement of production range.


Our procedure:
 

  • actual analysis and definition of planning task
  • general planning: layout plan of production and
    storage areas
  • determination of clean room areas and air conditioning
  • proposals for personnel and material flow
  • specification of prices, time and terms of delivery
  • detail engineering until the final realization in
    GMP compliance

 

Validation, Maintenance and Repair
 

CONCEPT GMP ENGINEERING has developed an extensive validation program for all phases: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ). Together with the customer we elaborate all documentations necessary for calibration, qualification and validation:

  •  validation master plan
  •  qualification plans for DQ, IQ, OQ, PQ
  •  protocols and Standard Operation Procedures (SOPs)


In addition to the elaboration of documents, our skilled qualification engineers implement calibration and qualification according to the given plans. Maintenance is the most important condition for a plant's
validation and for the manufacturing process. CONCEPT GMP ENGINEERING helps you to "keep the qualified status" by offering

  •  routine and preventive maintenance
  •  re-qualification
  •  maintenance plans and SOPs
  •  repairs and spare parts

 
    Technical Auditing
 

Different international guidelines define the criteria for the production and examination of pharmaceutical dosages. They form the basis of internal and external inspections.
CONCEPT GMP ENGINEERING offers technical auditing to support the customer in quality management and in the preparation of inspections by the authorities. Our experienced consultants investigate whether the existing or planned status corresponds to the requirements of the GMP guidelines and also to other criteria, e.g. DIN-ISO norms, safety regulations etc.
The audit refers to

  • rooms and equipment
  • personnel and processes
  • documentation
     
The inspection and the final audit report contain not only the determination of the present status with its weak points, but also suggests concrete measures and practice-corresponding solutions to achieve GMP conformity.