PHARMACEUTICAL INDUSTRY

Compliance becomes ever more important since regualtions change and are often amended. The focus must be on efficient compliance and transparent documentation. Keeping up with the frequent changes in this environment is a constant challenge for cost efficient solutions.

Auditing

Practical experience from more than 200 Audits combined with up-to-date expertise at your service. To support your supplier qualification or for internal gap analyses.

›Living quality managemnt‹
  • Project samples auditing
    • More than 90 audits and GMP-Gap analyses of  drug, API, and medical device manufacturers according to EU and US regulations (e.g. in Germany, Austria , Switzerland, France, Italy, Poland, USA, UK, Turkey, India, China, Indonesia, South Korea).
    • GMP- and business audits of suppliers (Sweden, Denmark, Ireland, Germany, Switzerland, Turkey).

Manufacturing

Quality is my concern. My primary goal is always to initiate effective change to increase both produrctivity and profit while guaranteeing full compliance.

›On Time & in Costs‹
  • Project samples manufacturing
    • Preparation of a German drug manufacturer for a US-FDA pre approval inspection. Project lead for more than a dozen consultants working on all relevant subjects (SOPs for manufacturing, QC, hygienic zones, logistics, labeling, etc.). Verification of conformity with regulatory submissions (analytical and manufacturing methods, manufacturing records).

QM Systems

Fully compliant quality management systems, taylor made for your enterprise – this is my promise. SOPs and QM handbooks that reflect real processes and operations. 

›Professional and efficient‹
  • Project samples QM-systems
    • Support of a Bulgarian drug manufacturer in establishing a GMP-compliant QM system as well as cleaning processes and equipment qualification.
    • Establishing of the cold chain transport validation program for a German drug manufacturer. Specific validation protocols for selected medicinal products.
    • Setting up a strategic purchasing department and implementing GMP-compliant processes as well as establishing a corresponding procurement manual.

One-stop shop - what you can expect.

Proven expert consulting for GMP compliance.
Independent professional freelance services. You benefit from 30 years experience in the industry. Want to learn more? See here for my full range of services.
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CAPA

Failures may occur. Unfortunately but unavoidably so. To minimize the possibility and to prevent expensive consequences one wants to identify the root cause and prevent it - for all future. Implementing effective risk management as well as corrective and preventive action is worth the effort. I am happy to support!


›Optimized manufacturing processes‹
  • Project examples CAPA
    • GMP-konforme Erarbeitung von Abläufen zur Behandlung von Abweichungen sowie Out-of-Specification-Resultaten in einem Pharmabetrieb. Erstellung der entsprechenden SOPs. GMPRisikoanalyse einzelner Prozessschritte in der Fertigung von Injektabila.
    • Projektleitung (Fresenius AG): Sicherstellung der Lieferfähigkeit während des Umzugs der Produktionsanlagen für Infusionslösungen von Bad Homburg nach Friedberg sowie nach Graz. Transfer der erforderlichen Produktdokumentation für mehr als 6.000 Artikel (Herstellunterlagen und Zulassungsunterlagen).

US-FDA

One wants to be well prepared when dealing with the "agency". I support your project as FDA-approved expert consultant from planning up to realization and inspection. My experience in both medicinal products and medical devices results from more than a dozen US-FDA inspections in which I supported as qualified translator in the front office.

›Inspection passed!‹

  • Project examples US-FDA
    • Expert consultant approved by FDA in a Voluntary COmpliance Program project. FDA waived an inspection after submission of the project documentation.
    • Front-Office support of FDA inspectionc through technically qualified translation services.
    • Preparation of numerous FDA inspections for medical device manufacturers. Project management as well as hands-on work (review and establishing of SOPs, structuring of design project and other documentation, DHF, DMR, DHR, trainings, etc.).
    • Training and gap analysis at a manufacturer of combination products to prepare US market entry.
    • Mock inspections at a manufacturer of metal and resorbable implants. Support in preparation for FDA inspection.
    • Writing and revising 510 (k) submissions for a German manufacturer of dental implants. 

Business processes

Business processes must be well aligned to be failure proof and to guarantee cost effectiveness. Implementing the acceptable level of compliance is key.






›Smooth processes - no failures‹
  • Project examples business process management
    • Project management services for Technical Due Diligences at various pharmaceutical and medical device production sites abroad (contract with a European investment group); services included GMP compliance status analyses and assessment, cost situation and prognosis, organization, key personnel, future utilization scenarios.
    • Project management for process optimization in an API production facility in Spain.  Reduction of operating costs according to preset aims. Implementation of performance specifications.
    • Business process optimization and GMP compliance consulting for a biotech manufacturer of pharmaceutical products (project management, GMP gap analyses, cost analyses, improvement of internal operations).
    • Revision, assessment, and re-organization of procurement processes in a pharmaceutical production facility. Preparation of procurement organization for a planned major investment. Development of a procurement manual including descriptions of all processes and responsibilities.
    • Project management in the reorganization of manufacturing and the quality unit for a US mediacl device manufacturer resulting in significant cost improvements and faster QA processes.
    • Project mangement: Reduction of costs of printed packaging materials and rationalization of the procurement process.

MEDICAL DEVICES

Safety of products starts with their design. Risk management becomes an ever more important process and must be maintained for the full product life-cycle. I bring in my long experience to build the best suitable system.
Requirements in the medical device industry are as diverse as the products. MDR and IVDR, standards such as ISO 13485, special requirements in export markets (e.g. USA, Japan, South Korea) plus own expectations to quality define the requirements. Notified Bodies, authorities and customers regularly check compliance with these requirements. Bauer-Lewerenz Consulting provides cost efficient solutions to meet those requirements.

›Maximum security for products and patients‹
  • Project examples medical devices
    • Lead functions in mitigation projects after gap analyses.
    • Risk management and performance evaluation of an in-vitro diagnostic device in preparation for IVDR.
    • Regular speaker at the European Compliance Academy in „GMP for medical devices“.
    • Multiple GMP- and ISO-gap analyses of madical device manufacturers.
    • Trainings and gap analysis at a manufacturer of combination products for entry into the US market.
    • Establishing 510 (k) submission packages for a dental material manufacturer.

MANAGEMENT

I am happy to supprt at the interfaces of production, logistics, and quality management. Start-up companies and restrucutring projects will profit from my experience in the area to make your investment a success.

Organization

The combination of expertise in GMP-compliant processes and e.g.  SOP writing as well as feasibility studies and business process optimization is aunique offering for your business.

›Economical and viable‹
  • Project examples organization
    • Economic and organizational analysis of a large scale project (new manufacturing plant in Sweden).
    • Project management for the capacity increase and start-up of primary packaging products in Ireland.
    • Business process optimization: lead in a sub-project to assess 600 job positions and develop recommendations for re-organization.

Interim management

Is there a need for temporary management in QA functions? I am ready to support with my international experience.


›Sound analysis - solutions that work‹
  • Project examples interim management
    • Project examples available in personal conversations.

Strategy development

I offer my expertise at the interface of manufacturing, logistics, and QA/QC.


›High level consulting‹
  • Project examples strategy
    • International production planning and strategy for several sites in Europe.
    • Project management: cost effectiveness calculation, investment request and basic engineering for a large scale green field project in Germany.
    • Project management for process optimization in an API production facility in Spain.  Reduction of operating costs according to preset aims. Implementation of performance specifications.
    • Feasibility and cost analysis of possible new products for an API manufacturer in France.

CAPEX

Capital expenditure means long lasting decisions which must be well prepared. Many years of experience at your service for challenging or detailed analysis.

›Sound advice today - no regrets tomorrow‹
  • Project examples CAPEX
    • Project management services for Technical Due Diligences at various pharmaceutical and medical device production sites abroad (contract with a European investment group); services included GMP compliance status analyses and assessment, cost situation and prognosis, organization, key personnel, future utilization scenarios.

You are interested in my services? 
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