Biotechnology is an interdisciplinary field that utilises biological systems, organisms or parts thereof to develop products or services that can be used for various applications in industry, agriculture, medicine and environmental management. It encompasses various technologies based on biological processes.
The high demands on safety, efficacy and reliability make quality management (QM) an indispensable element in biotechnology. We would like to explain the basics, challenges and the importance of effective quality management in biotechnology in more detail here.
AREAS OF BIOTECHNOLOGY
1. RED BIOTECHNOLOGY (MEDICINE AND HEALTH)
- Development of drugs, vaccines and gene therapies.
- Diagnostic procedures such as PCR tests or biomarker analyses.
- Production of insulin, hormones and antibodies.
- Regenerative medicine (e.g. tissue cultures, stem cell research).
2. GREEN BIOTECHNOLOGY (AGRICULTURE)
- Development of genetically modified plants that are resistant to diseases, pests or environmental stress.
- Improving the nutrient composition of food.
- Use of biological pesticides and fertilisers.
3. WHITE BIOTECHNOLOGY (INDUSTRIAL PROCESSES)
- Utilisation of microorganisms or enzymes for the production of chemicals, biofuels and plastics.
- Optimisation of industrial processes through environmentally friendly procedures.
- Fermentation technologies and bioreactors.
4. BLUE BIOTECHNOLOGY (MARINE APPLICATIONS)
- Research and utilisation of marine organisms for pharmaceutical, cosmetic or industrial applications.
- Extraction of active ingredients from algae or marine bacteria.
5. GREY BIOTECHNOLOGY (ENVIRONMENT)
- Bioremediation: Use of microorganisms to clean up soil, water and air.
- Development of methods for waste utilisation and recycling.
- Use of biological agents to combat environmental pollution.
BASICS OF QUALITY MANAGEMENT IN BIOTECHNOLOGY
Quality management encompasses all systematic measures aimed at ensuring and continuously improving the quality of products and services. In biotechnology, this means in particular
COMPLIANCE WITH REGULATIONS AND STANDARDS
Biotechnological products are subject to strict regulatory requirements, e.g. by the European Medicines Agency (EMA) or the US Food and Drug Administration (FDA). Standards such as ISO 9001 and specific guidelines such as Good Manufacturing Practice (GMP) play a central role.
VALIDATION AND VERIFICATION
Processes, methods and systems must be carefully validated and verified to ensure that they deliver consistent and reproducible results.
RISK MANAGEMENT
Identifying, analysing and minimising risks is essential to ensure the safety of end products. Biotechnology creates new types of risks in particular, as complex natural processes cannot yet be fully recognised and understood, and their complexity means that they often elude experimental testing.
CORE AREAS OF QUALITY MANAGEMENT IN BIOTECHNOLOGY
QUALITY ASSURANCE (QA)
Quality assurance comprises the planning and implementation of measures to ensure that products fulfil the required quality standards. Examples are
- Creation of standard operating procedures (SOPs).
- Regular staff training.
- Documentation and traceability of all production steps.
QUALITY CONTROL (QC)
Quality control includes the inspection of raw materials, intermediate and end products. The aim is to ensure that they meet the defined specifications. Typical test procedures include
- Microbiological tests for contamination testing.
- Chemical analyses to determine the concentration of active ingredients.
- Physical tests, e.g. for stability or viscosity.
REGULATORY MANAGEMENT
An effective biotechnology QM system must ensure that all regulatory requirements are met. This includes
- Preparation and maintenance of the required authorisation documents.
- Communication with authorities.
- Compliance with change requirements for new or amended regulations.
ADVANTAGES OF EFFECTIVE QUALITY MANAGEMENT IN BIOTECHNOLOGICAL AREAS
A well-implemented quality management system in biotechnology has numerous advantages. It ensures the safety of products, which strengthens both consumer confidence and the reputation of the company. Safety and trust are systematically increased.
Standardised processes and error prevention can reduce costs and increase efficiency.
A robust QM system facilitates compliance with legal regulations. The targeted management of compliance reduces the risk of penalties, claims for damages or even production downtime.
CHALLENGES IN BIOTECHNOLOGY QUALITY MANAGEMENT
Biotechnology is so complex because it is an interdisciplinary field that combines many scientific disciplines and is based on the dynamics of living systems. This complexity of biotechnological products and processes poses specific challenges for QM.
Technological advances: The integration of new technologies such as CRISPR, bioreactors or artificial intelligence requires constant adjustments to QM systems.
Globalisation: International supply chains and production sites require uniform quality assurance across different countries.
Resource management: Ensuring quality can be resource-intensive, which requires effective planning and utilisation of resources.
PEROBA QUALITY MANAGEMENT FROM MUNICH
CONSULTING, IMPLEMENTATION, AUDITS AND QM TOOLS FROM A SINGLE SOURCE
Due to their special characteristics, complex business areas such as biotechnology also require a very well-founded approach to quality management issues. Although experience and best practices from other business sectors are helpful, they can rarely be applied 1:1. Here it is advantageous to know as many of the available methods and tools as possible and to include them in the planning of quality management.
PeRoBa GmbH Munich is a service provider with many years of experience in quality management, especially in the automotive and mechanical engineering sectors. We help with all important standards on the way to certification or re-certification. We also work closely with universities and research institutes. Managing Director Dr Scherb teaches as a lecturer at the Hamburger Fern-Hochschule, the FOM in Munich and is also a speaker at the TÜV-Süd Akademie, the Bildungswerk der Bayerischen Wirtschaft and many other institutions.