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

1. QUALITY MANAGEMENT
1.1 Companies carrying out secondary packaging of pharmaceutical products should
establish and maintain a Quality System setting out responsibilities, organisational
structure, resources, processes, procedures and other activities necessary to ensure
confidence in the quality of the products released for supply after secondary packaging.
1.2 The Quality System should be fully documented and its effectiveness monitored on a
regular basis. All Quality System related activities should be defined and documented. A
Quality Manual or equivalent documentation approach should be established and
maintained.
1.3 Management should appoint a Quality Assurance Officer who should have defined
responsibilities for ensuring that a Quality System is implemented and maintained.
1.4 A system should be established and maintained to approve suppliers of packaging
materials to be used in secondary packaging. In the case of critical materials such as
printed packaging materials, the reliability of the suppliers may need to be verified by
the Quality Assurance Officer conducting on-site audits.
1.5 The Quality System should ensure that:
a. Management responsibilities are clearly defined.
b. A system of change control is in place to document and manage any changes that
may impact the quality of the final product.
c. Appropriate corrective and preventative actions (commonly known as CAPA) are
taken (and documented) to correct deviations and prevent their re-occurrence.
2. PERSONNEL
Key Personnel
2.1 Key personnel include Person in charge of secondary packaging and Quality Assurance
Officer. They must be independent from each other. There should be a staff
organisation chart showing this independence.
2.2 The company should appoint a Person in charge of secondary packaging to be
responsible for the following activities:
a. Establish and maintain the company’s Quality System, and coordinate regular
reviews of the effectiveness of the Quality System.
b. Supervise the secondary packaging operations.
c. Ensure that products are packaged and stored according to the appropriate
documentation in order to obtain the required quality.
d. Approval of documentation and procedures relating to secondary packaging
operations.
e. Check the maintenance of premises and equipment.
f. Coordination of self-inspections.
g. Ensure that the required training of his department personnel is carried out and
adapted according to need.
2.3 The company should also appoint a Quality Assurance Officer to be responsible for the
following activities:
a. Establish and maintain the company’s Quality System, and coordinate regular
reviews of the effectiveness of the Quality System.
Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products Page 4