Good Manufacturing Practice (GMP)
Definition and objective
GMP is a major quality control strategy with emphasis on the “process quality”. The objective of GMP is to follow quality standards. Quality alone cannot be sufficiently tested to the product.
Manufacturers of medicines for human or veterinary use, are subject to regulation by regulatory authorities such as FDA or EU. They are legally obliged to comply with GMP. Manufacturing, distribution and marketing require a manufacturing authorization (MA).
Qualification and validation are key elements 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 is specialized in the qualification of process equipment and analytical instruments, and in the validation of bioprocessing, bioanalytical test methods and bioassay procedures.
We are contributing to regulatory requirements for GMP release of samples according to customer’s needs and exigencies.
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 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 Services
- Validation Services
- Commissioning & Qualification
- CSV & Data Integrity
- Quality Control Testing
- In-process Testing
- Scientific and Laboratory Assistance
- Upstream & Downstream Operations
- Technical Transfer
- Risk Management
- Statistical Analysis
GMP Expertise
- Manufacturing of biotechnological products
- Manufacturing of Immunotherapeutics (ATMPs)
- Cell and Molecular Biology
- Gene Technology
- Quality of Biotechnological Products
- Specification of Biotechnological Product
- Analytical Procedure Development
- Preclinical Development
- Pharmaceutical Quality System
- Quality Risk Management
- Data Integrity and computerized Systems (CS)
- European Commission’s Guide to GMP
- ICH Quality Guidelines
Our aim is to contribute to the implementation of GMP quality standards as they pertain to the production and control of sterile manufactured biopharmaceuticals and immunotherapeutics (ATMPs).