A proactive approach to Good Manufacturing Practices is the cornerstone of Luina Bio’s reputation as a leading manufacturer of pharmaceutical products
The pharmaceutical products (like drugs or biologics) used in therapeutics for human diseases and disorders must be safe, effective and of good quality. Good Manufacturing Practices (GMP) can help to ensure that manufacturers can consistently produce products that meet the quality, purity and strength appropriate to their intended use.As the name implies, GMP applies across all stages of the manufacturing process and the product’s lifecycle, with the degree of stringency increasing as the product progresses from clinical trials through to commercialization.
With the addition of “current’ to GMP regulations, statutory agencies have signalled to manufacturers that regulations are regularly updated – every 10 years, for example, in the United States – and that they must use the latest technologies and processes.
There is, therefore, an obligation on pharmaceutical and biotech companies that produce therapeutic products to ensure that they keep abreast of regulatory changes and advances in technology.
The regulatory landscape
In the United States, the approval process for new drugs and pharmaceutical products falls under Title 21 of the Code of Federal Regulations (CFR). The pharmaceutical or drug quality-related regulations appear in several parts of Title 21 of the code. For example, Parts 314 and 600 refer to the application and licensing requirements for new and generic drug applicants, Part 210 covers cGMP in Manufacturing Processing, Packing, or Holding of Drugs and Part 211 relates to cGMP for Finished Pharmaceuticals.
The US Food and Drug Administration (FDA) is the agency for responsible for enforcing cGMP and sets minimum standards for cGMP compliance, with similar agencies operating across other countries, such as the Medicines and Healthcare products Regulatory Agency in the United Kingdom and the Therapeutic Goods Administration (TGA) in Australia.
There are also transnational cGMP standards published by the European Union as well as The World Health Organization, which is used by regulators and the pharmaceutical industry in over one hundred countries worldwide, primarily in the developing world.
Following the publication, in 1999, of GMP for Active Pharmaceutical Ingredients by the International Conference on Harmonization (ICH), GMPs now apply in countries and trade groupings that are signatories to the ICH (the EU, Japan and the US). And also apply in countries (e.g., Australia, Canada, Singapore) which adopt ICH guidelines for the manufacture and testing of active raw materials.
Additionally, many countries’ authorities perform Pre-Approval Inspections for GMP compliance prior to the approval of a new drug for marketing.
Ensuring compliance with cCMP
To comply with cGMP regulations, manufacturers, at a minimum, must implement systems for controlling every stage of the manufacturing process, from oversight and control of raw materials and components, to design, processing, testing, packaging and labelling, and storage and distribution. And that such systems must also account for regulatory updates and advances in technologies, equipment and processes.
Today, cGMP regulations have been established with flexibility in mind, and permit manufacturers to use their discretion when implementing the most appropriate controls for their particular circumstances.
However, it is the responsibility of pharmaceutical and biotech companies to ensure that their products comply with cGMP standards and holds even if some or all of the manufacturing activities are outsourced to a third party, such as a contract manufacturing organization (CMO).
Therefore, the choice of CMO is paramount in ensuring cGMP regulations are met.
For Luina Bio, the “current” in cGMP means providing clients with the assurance that their products are being manufactured under the most appropriate conditions, using the most up to date equipment and practices.
As one of Australia’s most experienced CMOs, Luina Bio offers a range of services including the production of cGMP material for preclinical studies and clinical trial material batches for Phase 1, 2 and 3 clinical studies. The company has actively invested in the resources and technologies necessary for ensuring that it is not only up-to-date but that it is “top-of-the-line.”
Based in Brisbane, Luina Bio’s manufacturing follows international cGMP guidelines set out in the Pharmaceutical Inspection Co-operation Scheme’s Guide to Good Manufacturing Practice for Medicinal Products Part II (PIC/S 009-8). And the facility is audited routinely by the TGA and the company’s clients as part of their due diligence and regulatory compliance.
About Luina Bio
Luina Bio is a Brisbane, Australia based, drug development and contract manufacturing organization (CMO) serving the pharmaceutical, biotechnology and veterinary industries.