GMP Compliance Consulting – Biotechnological Products and ATMPs
Definitions and objective of GMP
Good Manufacturing Pratice (GMP) is a major quality control strategy with emphasis on the process quality. Quality alone cannot be sufficiently tested to the product.
Manufacturers of pharmaceutical products are legally obliged to comply with Good Manufacturing Practice (GMP). The objective of GMP is to follow quality standards to ensure the safety, efficacy and quality of medicinal products.
Why do we need GMP ?
Pharmaceutical products are subject to high quality standards as part of submission for regulatory approval. Among these are: reporting adverse drug reactions; monitoring clinical trials and conducting inspections of manufacturers; compliance with good clinical practice (GCP); good manufacturing practice (GMP); good distribution practice (GDP), and good pharmacovigilance practice (GVP).
For their manufacture, distribution and marketing authorization, a manufacturing license is required. Therefore, for a drug manufacturer, the manufacturing authorization is an essential GMP property.
Qualification and validation are key GMP requirements for the implementation of those quality standards. Validation operations, especially in producing sterile biopharmaceuticals, can be very challenging. The procedures are arduous and requires conscientiousness and commitment, knowledge and experience, as there are predetermined specifications and regulations to meet.
Our company specializes in the qualification of process equipment and analytical instruments, and in validation of bioprocessing, bioanalytical test methods and bioassay procedures.
Key Benefits
Quality Control Activities
- Participating in testing of samples linked to quality control operations, validation and qualification, utility and environmental monitoring testing.
- Design, development and validation of analytical methods including analytical instrument qualification.
- Contributing to maintenance, calibration and qualification of laboratory equipment.
- Devise and revision of GMP-relevant documents.
- Contributing to GMP inspection preparedness of quality control processes to ensure GMP compliance.
- Technology Transfer
- Quality Compliance Consulting
Quality Assurance Activities
- Contributing to QA activities, e.g. CAPA, change control, periodic review, SOPs and documents for qualification and validation.
Audits and Inspections
- Contributing to inspection preparedness with regulatory authorities.
Technical Project Management
- Design and execution of small to mid-size investment projects with direct impact on production and business performance.
- Performing process engineering calculations and support plant optimization activities.
- Conducting feasibility studies for new installations or modifications to existing systems, cost estimation, scheduling and functional assessment.
- ATMP feasibility studies
- GAP-Analysis
- Project Lead and Team Coordination
Concept Development
- Development, design and evaluation of potential technical solutions, including assessment of advantages and limitations.
- Applying the Lean GMP Validation Concept
Process Optimization
- Optimizing process flows, implementing solutions and lean validation concepts to qualification and validation processes.
Technology Transfer
- Contributing to technology transfer.
- Concept and design of transfer projects, e.g. analytical test methods, processes, manufacturing and production.
Resource Management
- Coordinating and securing all required internal and external resources to ensure timely and professional project execution.
- GAP-Analysis
GMP Training
- Training and mentoring technicians and staff in GMP and laboratory competencies.
History of GMP
The origin of GMP goes back to the USA of 1883, when the first recommendations for “Food and Drugs” were introduced under the direction of Harvey W. Wiley who, at that time, investigated food preservatives.
Noteworthy incidents have paved the way towards regulations and modern quality standards. Tetanus contaminated diphtheria vaccines, that caused numerous deaths, led to the Biologics Control Act of 1902. The unsatisfactory conditions of Upton Sinclair’s meat-packaging led to the Meat Inspection Act of 1907.
The Sulfanilamide tragedy followed in 1937 that caused the deaths of more than 100 people (mostly children) after using a drug that was clearly unsafe, led to the Federal Food, Drug and Cosmetic Act (FDC Act) of 1938. Last but not least, the Cutter incident in the 1950s (a failed process step of inactivating living polio virus) caused over 40.000 polio infected patients and, subsequently, the abrogation of the first mass vaccination program.
Due to failed quality controls at that time, an obviously clearly unsafe polio vaccine was used. All this has led to regulations and incorporation of quality standards into drug manufacturing and their control, that have come to be known as today’s GMP.
GMP Expertise
- Manufacturing of Biotechnological Products
- Manufacturing of Gene and Cell-based Therapy (ATMPs)
- Cell and Molecular Biology
- Quality of Biotechnological Products
- Specification of Biotechnological Product
- Pharmaceutical Quality System
- Quality Risk Management
- Data Integrity and Computerized Systems (CS)
- European Commission’s Guide to GMP
- ICH Quality Guidelines
GMP Services
- Validation Services
- Qualification Services
- CSV & Data Integrity
- Quality Control Testing
- In-process Testing
- Scientific and Laboratory Assistance
- Upstream & Downstream Operations
- Technology Transfer
- Statistical Analysis
Our aim is to contribute to the implementation of GMP quality standards related to the manufacturing and control of sterile biopharmaceuticals and gene and cell-based therapy (ATMPs).