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///Strategy

///Packaging and Storage


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:

  • Glass
  • High density polyethylene(HDPE) resin
  • Metal

Components of packaging are
ampules, vials, bottles.
Container liners and tube liners.
Closure
  • Screw Caps
  • Stoppers

Closure liners
Stopper over seals
Container inner seals.
Administration ports in large volume parentrals.
Administration accessories and container labels.

Two types if components:
  1. Primary packaging component-is in direct contact with the dosage form
  2. A secondary packaging component is not and will not be in direct contact with the dosage form

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

Highest High Medium Low
Inhalation Sterile powders
Aerosols powders for injection
Solution Inhalation Inhalation powders
Injections
Injectable suspensions
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:

  • Protection from the exposure to light.
  • Protection form loss of solvent.
  • Protection from exposure to reactive gases.
  • Protection from absorption of water vapor.
  • Protection from microbial contamination.
  • Compatibility-means packaging components do not interact with drug products. Examples include absorption, adsorption or degradation of the active drug substances induced by a chemical entity leached from packaging components, reduction in the concentration of excipients due to above mentioned factors, precipitation, changes in drug product pH, discoloration of either drug product or the packaging components increase in the brittleness of the components.

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.


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