Commercial dose non-sterile liquid and semi-solid products, such as ointments, gels, and topical creams, offer a number of advantages to users, such as individual dosing, ease of use and suitability for paediatric and geriatric populations.
Contract manufacturing companies support pharmaceutical companies by ensuring the stability of the formulations during production, especially liquid products.
Identifying the top commercial dose (non-sterile) companies in contract manufacturing
Pharmaceutical Technology has listed the leading commercial dose non-sterile companies in contract manufacturing based on its intel, insights, and decades of experience in the sector. The list includes companies that provide various products and services including, but not limited to:
- Analytical testing
- Pilot manufacturing
- Commercial manufacturing and launch
- Packaging, and
- Supply chain and warehousing support
The information contained within the download document is intended for pharmaceutical manufacturers, pharmaceutical executives, product development managers, quality control executives, production engineers, and any other individual involved in pharmaceutical manufacturing.
The document contains detailed information on the suppliers and their products, alongside contact details to aid your purchasing or hiring decisions.
Safety in commercial dose non-sterile products manufacturing
Commercial dose non-sterile drug products are required to demonstrate microbiological purity criteria and are produced in controlled conditions that do not require the environment to be completely free from microorganisms. However, microbial contamination remains one of the major reasons behind product recalls of commercial dose non-sterile products.
Contract manufacturing organisations that provide manufacturing services for commercial dose non-sterile products in the pharmaceutical industry need to ensure that their facilities are tested for microbiological contaminants and comply with the regulatory standards set for the production of these products.
Manufacturers should also routinely test their facilities for the presence of microorganisms through environmental monitoring and test their impact on the product, as well as implement effective controls to mitigate the impact. Furthermore, manufacturers can adopt risk assessment tools and certain regulations that apply to sterile manufacturing facilities to prevent microbial contamination.
FAQs
What are non-sterile commercial dose products in pharmaceuticals?
Non-sterile commercial dose products include liquid, semi-solid, and solid forms such as creams, ointments, gels, and tablets. These products are not required to be sterile but must meet specific microbial purity standards. They are commonly used for topical applications, oral formulations, and certain over-the-counter (OTC) medications, designed for ease of use and suitable for paediatric and geriatric populations.
What factors ensure the safety of non-sterile pharmaceutical products?
Safety in non-sterile pharmaceutical production is ensured by strict microbial contamination controls. Manufacturers perform environmental monitoring and routine microbial testing to meet regulatory standards, preventing contamination during production and ensuring product quality. Risk assessment tools and procedures borrowed from sterile environments are sometimes applied to mitigate contamination risks.
How do contract manufacturing organisations (CMOs) support non-sterile pharmaceutical production?
CMOs offer services such as analytical testing, pilot manufacturing, commercial-scale production, and packaging for non-sterile products. They provide the infrastructure and expertise to meet regulatory standards and ensure products are safe for the market. Their role allows pharmaceutical companies to focus on R&D while outsourcing large-scale production and quality control to specialised firms.
Why are microbial contamination controls critical in non-sterile drug manufacturing?
Microbial contamination can compromise the safety and efficacy of non-sterile drugs, leading to recalls and regulatory issues. Rigorous microbial testing and environmental monitoring are essential to prevent contamination during manufacturing, especially in liquids, ointments, and semi-solid products. CMOs implement controls that monitor for bacteria, mould, and other contaminants to ensure product integrity.
What challenges do non-sterile pharmaceutical manufacturers face in production?
Non-sterile manufacturers face challenges such as maintaining microbial control, meeting stringent regulatory requirements, and ensuring consistent product quality. The complexity of handling various formulations, such as liquids or semi-solids, requires specialised equipment and strict adherence to Good Manufacturing Practices (GMP). Additionally, managing supply chains and scalability during commercial launch can also be a significant challenge.