Luina Bio offers an inclusive set of services including the production of cGMP material for preclinical studies and clinical trial material batches for Phase 1, 2 and 3 clinical studies. What does the “current” in current Good Manufacturing Practices (cGMPs) mean?
In the United States, the phrase “current good manufacturing practice” appears in 501(B) of the 1938 Food, Drug, and Cosmetic Act (21USC351). US courts may theoretically hold that a drug product is adulterated even if there is no specific regulatory requirement that was violated as long as the process was not performed according to industry standards. FDA’s cGMP regulations for drugs establish minimum standards for cGMP compliance. But in order to comply with cGMPs, manufacturers at the minimum are required to establish systems to
control every stage of the manufacturing process, including oversight and control of raw materials and components, design, processing, testing, packaging and labeling, storage and distribution. If implemented properly, these controls help assure that the product is of high quality and unadulterated, and help to prevent the release of nonconforming products.
The World Health Organization (WHO) version of cGMP is used by pharmaceutical regulators and the pharmaceutical industry in over one hundred countries worldwide, primarily in the developing world. The European Union’s GMP (EU-GMP) enforces more compliance requirements than the WHO GMP, as does the Food and Drug Administration’s version in the US. Similar GMPs are used in other countries, with Australia, Canada, Japan, Singapore and others having highly developed and sophisticated cGMP requirements. In the United Kingdom, the Medicines Act (1968) covers most aspects of GMP.
Since the 1999 publication of GMPs for Active Pharmaceutical Ingredients, by the International Conference on Harmonization (ICH), GMPs now apply in those countries and trade groupings that are signatories to ICH (the EU, Japan and the US), and applies in other countries (e.g., Australia, Canada, Singapore) which adopt ICH guidelines to the manufacture and testing of active raw materials.
GMPs are enforced in the United States by the Food & Drug Administration (FDA). Similar agencies for other jurisdictions include, the European Medicines Agency (EMEA) in Europe, the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, and the Therapeutic Goods Administration (TGA) in Australia. These agencies carry out routine GMP inspections to ensure that drug products are produced safely and correctly.
Additionally, many countries perform Pre-Approval Inspections (PAI) for GMP compliance prior to the approval of a new drug for marketing. Some regulatory agencies are authorized to conduct unannounced inspections. US courts have held that any time the firm is open for business is a reasonable time for an inspection. Therefore manufacturers with aging facilities and technology are certainly in danger of being found by inspectors to not meet the requirement to remain “current” under cGMPs. These companies are more likely to experience problems with quality, and correcting those problems may be expensive for these manufacturers.
On the other hand, Luina Bio has actively invested the appropriate resources over time to remain “current” under cGMP. In addition Luina Bio uses a proactive approach to cGMP to ensure for all our clients that the products that we make for them are safe, pure, and effective.
Luina Bio uses systems and equipment to prevent contamination, mixups, and errors, that is not only up-to-date but that is “top-of-the-line.” Luina Bio is one of Australia’s most experienced biopharmaceutical contract manufacturing organisations offering trusted client
focused cGMP services to both a domestic and international client base.
Luina Bio has a total quality assurance system developed and inspected in accordance with local and international requirements. The LuinaBio facility follows the international GMP guidelines as setout in the (PIC/S) “Guide to Good Manufacturing Practice for Medicinal
Products Part II (PIC/S 009-8). Australia is a founding member state of the Pharmaceutical Inspection Co-operation Scheme resulting in the guidelines being adopted by the TGA. As such our TGA license is also recognized by other PIC/S (Pharmaceutical Inspection Cooperation Scheme) member countries. The facility is audited routinely by the TGA and by our clients as part of their due diligence and regulatory compliance.
At Luina Bio, the “current” in current good manufacturing processes means that we offer our clients the confidence that their product is being manufactured under the most appropriate conditions, using the most up to date practices.
About Luina Bio
Luina Bio is a Brisbane, Australia based, drug development and contract manufacturing organization (CMO) serving the pharmaceutical, biotechnology and veterinary industries.