Projects
- MONOGRAPH PHARMA provides end-to-end solutions right from facility conceptual engineering design to successful commissioning of facility with requisite international regulatory approvals like EUGMP, TGA, PIC/s, etc. Solutions provided are based on the principles of GEP & GMP.
- The rich experience of Team MONOGRAPH PHARMA inherently ensures Economics of Basis of Design (CAPEX & OPEX), Efficient & Lean Process Operations, Ease of Maintainability, Flexible Plant Operation Philosophy (multi-product manufacturing) & Sustainable Compliance with Optimal Investments in both Greenfield projects and Brownfield projects.
- MONOGRAPH PHARMA provides end-to-end solutions right from facility conceptual engineering design to successful commissioning of facility with requisite international regulatory approvals like 21 CFR, EUGMP, TGA, PIC/S, ISO etc. The solutions provided are based on the principles of GEP & GMP.
The projects designed for dosage forms that we work include, but not limited to
- Oral Solids
- Oral Liquids
- Topical preparations - Ointments, Creams, Dusting powders, etc.
- Parenteral preparations - Large & Small volume injectables
- Suppositories
- Trans-dermal patches
What Is a Greenfield Facility?
A greenfield site entails the construction of a manufacturing facility from the ground up. The manufacturer has more flexibility to customize the structure’s design to the project’s unique requirements. With proper planning, the site can also accommodate future growth more efficiently. Maintenance costs are usually lower than with a brownfield facility, as the building, equipment and machinery are typically brand-new and in peak operating condition.
One drawback to opening a greenfield site is time. It may not be a viable option if the manufacturer must act quickly to keep up with customer demand or bring a new product to market when there is an immediate need. Hiring new staff and onboarding can also introduce a significant learning curve and lengthen the time frame until operations are up to speed.
At MONOGRAPH PHARMA, our Projects Division is committed to delivering excellence in completion of projects ONTIME.
What Is a Brownfield Facility?
A brownfield manufacturing process utilizes a suitable existing facility and infrastructure. In many cases, the manufacturer will either purchase or lease the structure and perform any modifications required to complete the “fit-out”. In many brownfield projects, production is already occurring and personnel who are familiar with the projects and compatible quality control systems are in place. This may even be an existing facility within the corporate structure of the company.
The most obvious advantage of choosing a brownfield site is a faster implementation. There’s no need to wait for the construction of a new facility, which could take a year or longer. If executed correctly, the transition to a brownfield facility can be quick and seamless, reducing downtime and minimizing disruptions that negatively impact service.
Regulatory
- Regulatory Affairs
- Product Development
- Regulatory Gap Assessment
- Regulatory Due Diligence Audit