Primary packaging is the term used to assign the layer of packaging in direct contact with the product or dosage form; in simple words actually, it is the first packaging layer in which the product is stored. Primary packaging material means any single part of a container closure system, for example, containers, container liners, closures, closure liners, stopper oversells, etc. A secondary packaging material is a packaging component that is not and will not be in direct contact with the dosage form.
Standard on Product Containers & Closures
Current Good Manufacturing Practice (cGMP) requirements for the control of drug product containers & closures comprise 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. 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.
Primary Packaging Layout Design :
Packaging layout design is an important element while setting up a manufacturing unit. While designing the plant/facility layout, the 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.
Primary Packaging Process Validation:
Operon Strategist guides manufacturers & validation service providers on the validation activity & documentation. We study the product, production facility and accordingly design the validation master plan which outlines the packaging process validation activities to be performed & timeline for the same.
Operon Strategist provides worldwide services to the primary packaging and pharma industries, including strategic, regulatory and environmental compliance. Our expertise helps customers in highly regulated industries to achieve compliance, efficiency and sustainable business success.