Packaging materials - I
Packaging materials should also be controlled by the manufacturer. Specific attention should be given, and controls exercised for primary packaging materials, and printed packaging materials. The product will come into direct contact with the primary packaging materials. Special care should be given to the quality of these materials such as ampoules, bottles and foil used in blister or strip packing. The prevention of mix-ups of printed packaging materials such as leaflets, labels and cartons is of great importance. The guidelines recommend that the purchase, handling and control of primary and printed packaging materials should be as for starting materials. (There should thus be approved suppliers and specifications for these materials. They should be quarantined on receipt, sampled and tested before release or rejection).
The access to printed packaging material should be controlled to prevent any unauthorized access. Cut labels and other loose printed packaging materials should be stored and transported in separate, closed (sealed) containers to prevent possible mix-ups. Only designated personnel should issue printed packaging materials to production. The issue (and return when allowed) of printed packaging materials should be done in accordance with written SOPs.