QualityAssurance: 21 CFR Part 210 & 211

Primary packaging material is defined as the material that that may or may not be in direct contact with the dosage form.Primary packagingmay comprise any single part of a container closure system including containers, container liners, closures, closure liners, stopper oversells, etc.A secondary packaging materialis a packaging component that is not in direct contact with the dosage form.

21 CFR Part 210 deals with the Manufacturing, Processing and Buildings of drugs, During 21 CFR Part 211 deals with finished pharmaceuticals .These cGMP  Guidance Things the pharmaceutical and drug-related industry.

Related Projects:


Name: GMP Guideline
Year: 2003
Type: Got it

ISO 15378 Consultant

Name: Quality Assurance ISO 15378
Year: 2001
Type: Got it