GMP von HORN Pharmaceutical Consulting

Von: HORN Pharmaceutical Consulting  08.07.2009
Keywords: Consulting, Training, Clinical Development

 Ensuring compliance with GMP requirements is specifically challenging. Your specialists need to set up your manufacturing processes and control procedures in line with the latest prerequisites in order to successfully pass inspections later on and in order to avoid compliance risks. You need to have an SOP-system in place covering all necessary GMP-requirements.  

At HORN Pharmaceutical Consulting, we can help you make things happen.
We will guide you in setting up efficient Quality Assurance (QA) systems, in training your personnel and in giving you precious advice for the preparation and conduct of inspections.  

Area of Expertise  
We can help you in setting adequate GMP-compliant standards for various kinds of finished medicinal products:
·         Biological products:
          o        Somatic cell therapy products
          o        Gene therapy products
          o        Tissue engineering products
 ·        Biotechnological products
          o        Recombinant proteins
          o        Antibodies
 ·        Chemically defined liquids, semi-liquids or solids
          o        Solutions for injection
          o        Salves
          o        Tablets
 ·         Chemical production 
          o        Active Pharmaceutical Ingredients (APIs) 

New QA Systems  
Establishment of a QA system can be a huge challenge for new pharmaceutical companies. QA systems should be designed with the aim of standardisation of working processes. Keeping in mind the substantial need for flexibility within the daily work, the design of a well balanced and GMP-compliant QA system should be the main focus in the developmental phase.  

Existing QA Systems  
Does your QA system need to be optimized based e.g. on inspections from Authorities or based on the need of improvement of working processes?   We can assist you realising your special needs by offering the following services:
·         Critical review of QA systems
·         Preparation of gap-analyses
·         Preparation of corrective action plans
·         Compliance-checks  

Qualification and Validation  
We are focussed on the development of qualification and validation strategies and can provide assistance in the development or critical review of:
·         Validation master plan
·         Qualification of equipment
·         Process validation
·         Method validation  

Inspections – Our look through the inspector’s eyes!  
Various forms of inspections are required for a pharmaceutical company. We are specialised in planning and conduct of mock-inspections and preparing inspection reports.   Based on such inspection reports or based on inspections from Authorities we can develop corrective action plans to ensure GMP-compliance. Furthermore, we prepare you for successful inspections from Authorities (FDA, EMEA, National Authorities)  

Contract manufacture and contract analysis is becoming more and more important in the current pharmaceutical business. Each party involved should be contracted. For reflecting your GMP standards to your contractors we prepare and review contracts and GMP arrangements  

GMP Training  
HORN Pharmaceutical Consulting is offering state of the art, cutting edge specifically tailored GMP trainings. After our GMP training, all participants will have gained a fundamental understanding of the basis of the regulations, the necessity of rigorously implementing them, monitoring compliance and pro-active thinking in all scientific matters. This way the risk of non-compliance and delays in the approval process can be minimized.   The GMP training course of HORN Pharmaceutical Consulting covers, but is not limited to the following areas:
·         Gain a thorough understanding of GMP-requirements (EU, US)
·         Development and training of Standard Operating Procedures (SOPs)
·         Preparation and conduct of inspections (FDA, EMEA, national supervisory Authorities)
·         Quality control and Quality Assurance (QA) systems
·         Analytical and laboratory validation and compliance programs
·         Chemical production, i.e. production of Active Pharmaceutical Ingredients (APIs)
·         Pharmaceutical production
·         Storage and labelling

Keywords: API (Active Pharmaceutical Ingredient) manufacturer, Biotech products, Clinical Development, Consulting, IND (Investigational New Drug Application), MAA (Marketing Authorisation Application), quality systems, SOPs, Training,

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