The food, drug and cosmetic act states that having adequate information related to packing materials is mandatory.
Packaging materials may be of any of the following types:
A container closure system together contain and protect the dosage form. This is also formed as a packaging system (21 CFR 600.3). This is also refers to associate components such as dosing caps, droppers and spoons and external packaging systems such as cartons and shrink wrap.
Quality of the above mentioned articles refers to physical, chemical, microbiological, biological, bioavailability and stability attributes that a drug product should maintain if it is to be deemed suitable for therapeutic or diagnostic use. As per cGMP, CPSC and USP requirements on containers and closures (21 CFR,210,211) Degree of concern associated with the route of administration is as per the following
|Aerosols||powders for injection|
|Solution Inhalation||Inhalation powders|
|High||Ophthalmic solutions and suspension|
|Transdermal ointments and patches|
|Nasal aerosols and sprays|
|Low||Topical solution||Topical powders and oral powders||Oral tablets and oral hard and soft gelatin capsules|
|Topical and sublingual aerosols|
|Oral solutions and suspensions|
Following checks may be made for the purpose of investigations of suitability in case of containers:
Therefore any change noted during the stability studies may be due to interaction between the dosage form and a packing component.
Safety: Packaging components should not leach harmful un indesirable amounts of substances to which a patient will be exposed when being treated with the drug product. Following studies need to be undertaken to check the safety (1) Extraction study (2) A toxicological evaluation of extractives (3) Absence of adverse reactions.
Performance (for assembled packaging system) - Functionality and or drug delivery QC involves tests and acceptance criteria, dimensional drawing, performance criteria, consistency monitoring.