Qualification and Quality Control of Packaging Components

A packaging system found acceptable for one drug product is not automatically assumed to be appropriate for another. Each application should contain enough information to show that each proposed container closure system and its components are suitable for its intended use. 

Highest inhalation, aerosols, sterile powders, and solutions powders for injections and injection inhalation, injectable, powders, suspensions 

High ophthalmic solutions and suspensions, trans-dermal ointments and patches, nasal aerosols and sprays 

Low topical solutions and topical powders oral tablets and oral suspensions topical oral powders (hard and soft and lingual aerosols gelatin), capsules, oral solutions, and suspensions 

Not every drug product is susceptible to degradation by all of these factors not all drug products are fight sensitive. Not all tablets are subject to loss of quality caused by absorption of moisture. Sensitivity to oxygen is most commonly found with liquid-based dosage forms. Laboratory studies can be used to determine which of these factors actually have an influence on a particular drug product. 

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