Primary Packaging Material is Defined 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.
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 are a mechanism that primary packaging manufacturers can use to share confidential information with health authorities without disclosing that information 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 has to be 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.
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