Pharmaceutical Manufacturing Handbook: Production and

162 PACKAGING AND LABELING
signifi cantly affect the stability of drugs and their dosage forms. It is crucial that
stability testing of dosage forms in their fi nal packaging be performed. The primary
role of packaging, other than its esthetic one, is to protect the dosage forms from
moisture and oxygen present in the atmosphere, light, and other types of exposure,
especially if these factors affect the overall quality of the product on long - term
storage [5] .
The compliance packaging such as for fi xed - dose combination pills and unit
dosage form packaging is a therapy - related intervention and is designed to facilitate
medication regimens and so potentially improve adherence. Compliance packaging
can be defi ned as a prepackaged unit that provides one treatment cycle of the
medication, to both the pharmacist and the patient, in a ready - to - use package. This
innovation type of packaging is usually based on blister packaging that contain unit
therapeutic dose for one time use. The separate dosage units and separate days are
usually indicated on the dosage cards to help remind the patient when and how
much of the medication to take, for example, blister packed oral dosage forms with
drug information leafl ets and contraceptive pills [6, 7] .
The selection of packaging material for any pharmaceutical product is as important
as proper pharmaceutical dosage form. To guarantee the safe and adequate
delivery of drug product to the patient and improve patient compliance, the manufacturer
should consider the following factors:
1. Compatibility and safety concerns raised by the route of administration of the
drug product and the nature of the dosage form (e.g., solid or liquid based)
2. Kinds of protection the container closure system should provide to the dosage
form (e.g., photosensitive, hygroscopic, easily oxidized drug products)
3. Potential effect of any treatment or handling that may be unique to the drug
product in the packaging system
4. Patient compliance to the treatment and ease of drug administration
5. Safety, effi cacy, and quality of drug product throughout its shelf - life
The acquisition, handling, and quality control of primary and secondary packaging
materials and of printed materials should be accomplished in the same way as
that for the raw materials. The printed materials should be stocked in a reserved
place so the possibility of unauthorized access is avoided. The labels and other
rejected printed materials should be stored and transported with proper identifi cation
before being destroyed. There should be a destruction record of the printed
materials. Each batch of printed material and packaging material should receive a
specifi c reference number for identifi cation.
The identifi cation affi xed on the containers, on the equipment, in the facilities,
and on the product containers should be clear, without ambiguity, and in a format
approved by the company and contain the necessary data. Besides the text, differentiated
colors indicating its condition could be used (e.g., in quarantine, approved,
rejected, and cleaned).
The packing materials should attend to the specifi cations, giving emphasis to the
compatibility of the same with the pharmaceutical product that it contains. The
material should be examined with relation to visible physical and critical defects as
well as the required specifi cations.