GMP compliance services and expertise for biologicals and ATMPs
“The holder of a manufacturing authorization must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the marketing authorization (MA) and do not place patients at risk due to inadequate safety, quality or efficacy”.
Manufacturer of medicines for human or veterinary use, are subject to regulation and requirements by regulatory authorities such as FDA or European Union (EU). They are legally obliged to comply with GMP. Manufacturing, distribution and marketing require a manufacturing license.
In order to apply for a marketing authorization (MA), the manufacturer has to hold a valid manufacturer’s and import authorization (MIA). The final responsibility for the performance of a biotechnological product over its lifetime, in terms of safety, quality and efficacy, lies with the “Manufacturing Authorization Holder” (MAH). It is indispensable to comprehend and apply the current GMP regulations and requirements to the manufacturing over the product`s life cycle.
Why do we need regulation?
Medicinal products are intended to cure, relieve or prevent diseases, but they also contain the potential to be unsafe or harmful.
Compliance to GMP is an ascertainment that the product, the manufacturing process, the manufacturing facilities, and the manufacturing environement meet applicable requirements to ensure the continued safety, purity and potency over the product`s life cycle.
What is a biological product ?
Biologicals products, also called biopharmaceuticals, are (mostly) proteins, mainly derived from living organisms or systems by using recombinant DNA technology. Recombinant proteins are then produced by cell expression systems or transgenic animals.
Currently biopharmaceuticals are being developed to fight against cancer, autoimmune disorders, infectious diseases and several other medical conditions.
Why are biologicals unique and different?
Proteins can be 100 to 1000 times largen than chemically synthetized small molecules. Due to their large size and complex structure, biopharmaceutical production entails complex manufacturing processes. They are highly sensitive to modification during and after production.
Therefore, biopharmaceuticals are different from synthetic small molecules in terms of molecular size, three-dimensional shape, and process specific impurities. The formulation of the final product is distinct in terms of excipients, bioactivity and stability.
The manufacturing process can affect many parameters, including amino-acid structure, side chains, post-translational processing and tertiary and quaternary structure. Changes could have a profound effect on protein function.
Inconsistencies during manufacturing can lead to inter-batch variations and inconsistency of efficacy. Regarding the manufacture of biopharmaceutical, the control of quality, safety and efficacy especially in terms of “batch-to-batch” consistency is more complex and sophisticated.
Product regulation for biological products
Product Safety
- Microbial agents
- Tumorgenicity
- Pyrogenicity
Product Characterization
- Identity
- Purity
- Impurities
- Potency
- Quantity
Manufacturing
- Process Control
- Validation Program
- Qualification Program
- Quality Control Tracking
- Quality Assurance Tracking
We are contributing to regulatory requirements for GMP release of samples according to customer’s needs and exigencies.
USA
- FDA Public Health Service Act (PHS Act) Section 315
- Food, Drug, and Cosmetic Act (FD&C Act) Section 505
- FDA 21CFR Part 210
- FDA 21CFR Part 211
- FDA 21CFR Part 58
- FDA 21CFR Part 201
- FDA 21CFR Part 207
- FDA 21CFR Part 300
- FDA 21CFR Part 314
- FDA 21CFR Part 600-680
- FDA 21CFR Part 800
- FDA 21CFR Part 820
German Regulatory Requirements
- Arzneimittel Gesetz (AMG)
- Arzneimittelwirkstoffverordnung (AMWHV)
- BfArM
- PEI
- ZLG
European Union
- Directive 2017/1572/EC
- Directive 2006/86/EC
- Directive 2006/17/EC
- Directive 2004/23/EC
- Regulation 1252/2014/EC
- Regulation 1394/2007/EC
- Regulation 536/2014/EC
- Regulation 726/2004/EC