GMP Services
GMP
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.
Manufacturer of medicines for human or veterinary use, are subject to regulation by regulatory authorities such as FDA or EMA. They are legally obliged to comply with GMP. Manufacturing, distribution and marketing require a manufacturing license.
Qualification and validation are key elements for the implementation of those quality standards.
Validation operations, especially in producing sterile biopharmaceuticals, can be very challenging. These involve much effort 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.
GMP Class
We give on-site training and workshops on specific topics, tailor-made to the company’s desire, products and processes.
Our aim is to support and contribute to the implementation of “GMP quality standards” as they pertain to the production and control of sterile manufactured biopharmaceuticals and gene therapies.
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 modern regulations and 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 (most of them were 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 vaccination) caused over 40.000 polio-infected patients after having received vaccination and, subsequently, the abrogation of the first mass vaccination program. All this has led to regulations and incorporation of quality standards into production and their control, that have come to be known as today’s GMP.
Your Benefits:
- Contributing to cGMP compliant processes
- Contributing to GMP release
- Supporting manufacturing authorization
- Supporting market and clinical trial authorization
Our GMP Expertise
- Sound and proven knowledge of qualification and validation operations
- Proficiency with GMP requirements and regulations
- Expertise with GMP regulation authorities (FDA, EMA, BfArM, PEI, ZLG)
- Expertise with Annex 15, and ICH Quality Guidelines
- Expertise with Annex 11 and GAMP
- Expertise in Aseptic Process Validation (Annex 1)
- Eudralex Vol. 4, EU GMP Guide I-IV,
- AMG, AMWHV
- FDA 21 CFR Subchapter A, C, D, F
- FDA 21 CFR Part 820
- Regulation (EU) 1252/2014; Regulation (EU) 536/2014, Regulation (EC) 726/2004, Regulation (EC) 1394/2007, Regulation (EU) 2017/1569
- Directive 2017/1572, Directive 2001/83/EC
GMP Services We Offer
- GMP compliance consulting
- Validation project management
- Commissioning of plant and line facilities
- Developing quality strategies for cGMP compliant manufacturing
- Cleanroom validation
- Data Integrity and validation of computerized systems (CSV) in quality control unit
- Risk management and risk assessment
- Supporting regulatory operations
- Technical Transfer of test methods and assays
- Facilitating technical GMP documentation