What is cGMP, and why is it so important?
The Current Good Manufacturing Practice (cGMP) is a process set up by the FDA to ensure medication is manufactured safely by all pharmaceutical companies. The FDA ensures the quality of all pharmaceutical products by meticulously monitoring all manufacturing compliance with the cGMP regulations.
The cGMP regulations include minimum requirements for:
Methods – How pharmaceutical products are produced.
Facilities – Where pharmaceutical products are made.
Controls – Used in manufacturing, processing, and packaging of pharmaceutical products.
What Are the Key Components of cGMP?
Regardless of what drug is being produced and how it's being produced, pharmaceutical companies are responsible for ensuring that the drug is produced safely and contains the exact ingredients specified.
One of the ways that the FDA ensures that pharmaceutical companies meet these requirements is by following and abiding by Current Good Manufacturing Practices (cGMP) regulations set out by the federal government.
The five key components of the cGMP include Primary Materials and Products, Premises, People, Procedures, and Processes.
Primary Materials and Products – These are the raw materials or ingredients used to create pharmaceutical products. Part of cGMP includes the requirements of a master formula for all pharmaceutical medications, which is meticulously followed, with no deviations.
Premises – Includes the laboratories where pharmaceutical medications are produced, and all premises must be correctly maintained to ensure safe and adequate conditions for manufacturing pharmaceutical products.
People – All people involved in the pharmaceutical product manufacturing process must be fully trained in cGMP procedures.
Procedures – Up-to-date and strict adherence to procedures is a vital part of the cGMP process. Companies are regularly inspected to ensure they adhere to all procedures set out in their cGMP procedures.
Processes – In cGMP are the documents that prove that full compliance with all procedures was followed during the manufacturing process. During the audit process of any facility, auditors assess all of these documents to ensure that cGMP procedures are followed and documented.
Companies that comply with cGMP receive GMP certification, which showcases their commitment to quality.
Laxxon Medical and Hovione Partnership Ensures cGMP Production of 3D Screen Printed Pharmaceutical Applications
Hovione and Laxxon Medical have partnered for the cGMP production of 3D Screen Printed pharmaceutical applications.
Utilizing Laxxon Medical's patented 3D Screen Printing process, SPID®-Technology, and Hovione's product & process development, engineering, and manufacturing expertise in pharmaceutical applications, this partnership will advance the use of 3D screen printing technology in the pharmaceutical industry.
“Laxxon is thrilled to establish a long-term partnership with Hovione,” said Klaus Kuehne, COO of Laxxon Medical. “This partnership will serve as a great accelerator in establishing 3D screen printing within the pharmaceutical industry, thus accelerating our ability to serve our customers.”
You can learn more about how the Laxxon Medical 3D Screen Printing process and SPID®-Technology work here.
Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations.
As a Contract Development and Manufacturing Organization (CDMO), Hovione has a fully integrated offering of services for drug substances, drug product intermediates, and drug products.
Hovione has four FDA-inspected sites in the USA, Portugal, Ireland, and China and development laboratories in Lisbon, Portugal, and New Jersey, USA, to ensure compliance with cGMP.
"Hovione has a global reputation for their pharmaceutical innovation services, expertise, and market access. This agreement marks a significant milestone for Laxxon in terms of our own market strategy and development efforts,” said Helmut Kerschbaumer, Laxxon’s CEO.
What Are the Advantages of 3D Screen Printed Pharmaceutical Applications?
Laxxon Medical's SPID®-Technology has various advantages, including the potential to produce unique or individualized dosage forms that you can't achieve with conventional dosage forms. As a result, individualized or customized medicine has huge potential in the future of healthcare.
Not only that, but SPID®-Technology allows for the production of tablets of any shape or size, the number of active substances or components within the composition of the tablets, and even the ability to set individual dosages based on specific patient requirements.
"We find the Laxxon Medical 3D printing technology to be very innovative and enabling. It not only allows for the customization and production of drug products with complex shapes and structures as well as unique API release characteristics, but it also has the potential to reduce the time and cost of drug development,” says Dr. Jean-Luc Herbeaux, Hovione’s CEO.
Another critical aspect of Laxxon Medical's SPID®-Technology is the ability to directly print QR codes onto 3D-printed pharmaceutical medication. QR codes would enable customers to ensure they get genuine medicines and have immediate access to drug information, including ingredients and strength. Also, authorities could quickly and easily identify and track pharmaceutical products for quality control and security purposes.
The combination of Laxxon Medical's 3D SPID®-Technology and Hovione's cGMP-approved facilities, and a combined 60 years of experience in pharmaceutical development and manufacturing operations, presents a future for 3D printed pharmaceutical applications that is looking very bright indeed!
Laxxon Medical is dedicated to engineering patented 3D pharmaceutical solutions which optimize products and benefit patients. Our goal is to establish SPID®-Technology as a manufacturing process that has the individual and the pharmaceutical partner in mind.