Hong Kong Guide to Good Manufacturing Practice for the Secondary ...

5. GOOD PRACTICES IN SECONDARY PACKAGING
5.1 The appropriate registered particulars of the pharmaceutical products that are subject to
secondary packaging should be complied with and, where necessary, the approval of the
holder of the Certificate of Drug/Product Registration should be sought if there is any
variation to the registered particulars.
5.2 When setting up a program for the secondary packaging operations, particular attention
should be given to minimizing the risk of cross-contamination, mix-ups or substitutions.
The secondary packaging of different products should not be carried out in close
proximity unless there is physical segregation.
5.3 Special care should be taken when using cut-labels and when over-printing is carried out
off-line. Roll-feed labels are preferable to cut-labels in helping to avoid mix-ups.
5.4 Written procedures should be available for the handling of any spillage or breakage
involving pharmaceutical products containing highly active substances (e.g. cytotoxics,
steroids, hormones, etc.) or highly sensitising substances (e.g. penicillins,
cephalosporins, etc.).
5.5 All products and materials used for secondary packaging operations should be checked
before use by a designated person for quantity, identity and conformity with the
Packaging Instructions.
5.6 Line clearance checks should be performed prior to commencement of each secondary
packaging operation. Steps should be taken to ensure that the working area, packaging
lines, printing machines and other equipment are clean and free from any products,
materials or documents previously used, if these are not required for the current
operation.
5.7 Each batch of product produced must be assigned a unique batch number which may
incorporate the original manufacturer’s batch number and a suffix to identify each
separate packaging run. Alternative batch numbering systems that provide full
traceability to each packaging run may be accepted.
5.8 The correct performance of any printing operation (for example batch number coding
and expiry dating) should be checked and recorded. Attention should be paid to printing
by hand which should be re-checked at regular intervals.
5.9 Printed and embossed information on packaging materials should be distinct and
resistant to fading or erasing.
5.10 On-line control of the product during secondary packaging should, where applicable,
include checking the following:
a. General appearance of packages.
b. Completeness of packages.
c. Correctness of products and packaging materials used.
d. Correctness of over-printing, e.g. batch number, expiry date.
e. Correctness of supplementary labels applied to products.
5.11 Any deviation from instructions or procedures should be avoided as far as possible. If a
deviation occurs, it should be approved in writing by the Quality Assurance Officer.
5.12 Any significant or unusual discrepancy observed during reconciliation of the amount of
printed packaging materials used and the number of units produced should be
investigated and satisfactorily accounted for before release for sale or supply.
5.13 Upon completion of a secondary packaging operation, any unused batch-coded
packaging materials should be destroyed and their destruction recorded. A documented
procedure should be followed if un-coded printed materials are returned to stock.
Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products Page 8