Primary Packaging Material is Define as the material that may or may not be in Direct Contact with the Dosage Form. Primary packaging may comprise any single part of a container closure system including containers, container liners, closures, closure liners, stopper oversells, etc. A secondary packaging material is a packaging component that is not in direct contact with the dosage form.
Primary Packaging Turnkey Project Consulting Services into Australia, Brazil, Bangladesh, Comoros, Costa Rica, Canada, Central Asia, Colombia, Egypt, Iceland, India, Indonesia, Nigeria, New Zealand, Oman, Peru, Qatar, Israel, European Union, Europe & Middle East, Hong Kong, Kenya, Korea, Kuwait, Liberia, Malaysia, Mexico, Mauritius, Saudi Arabia, Singapore, South & Central Asia, South Africa ,Southeast Asia & Pacific, Sri Lanka, Switzerland, Russia, Singapore, Turkey, Thailand, Ukraine, United Arab Emirates.
Current Good Manufacturing Practice (cGMP) Requirements for the control of drug product containers & closures are defined in 21 CFR Part 210 & 211. Drug master files is a mechanism. Which use by primary packaging manufacturers to share confidential information with health authorities. That information is not disclosing to the pharmaceutical industry.
In the US, Drug Master File (DMF) is a submission to the US FDA that may be used to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging & storing of one or more human drugs.
We Provide Primary Packaging Turnkey project services includes Following:
Facility/Plant Layout Design For Primary Packaging:
Facility layout & design is an important element while setting up a manufacturing unit. While design the plant/facility layout, due consideration is given to the regulatory requirements, in particular, the cGMP requirements. The layout thus designed has to ensure a smooth flow of man & material through the plant.
Clean room conceptualization For Primary Packaging:
Clean room helps in establishing & maintaining an environment with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles & chemical vapors.
Process Validation For Primary Packaging:
Operon Strategist guides manufacturers & validation service providers on the validation activity & documentation. We study the product & the production facility & accordingly design the validation master plan which outlines the validation activities to be performed & timeline for the same.