Hong Kong Guide to
Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products December 2014
Pharmacy and Poisons Board
Contents
PURPOSE (3)
SCOPE (3)
GLOSSARY (3)
1.QUALITY MANAGEMENT (4)
2.PERSONNEL (5)
3.PREMISES AND EQUIPMENT (7)
4.DOCUMENTATION (9)
5.SECONDARY PACKAGING (13)
6.QUALITY CONTROL (16)
7.CONTRACT PACKAGING AND ANALYSIS (17)
8PLAINTS AND PRODUCT RECALL (18)
9.SELF INSPECTION (19)
ANNEX (19)
PURPOSE
This guide to Good Manufacturing Practice (GMP) ts out the standards and requirements to be followed by licend pharmaceutical manufacturers only authorid to conduct condary packaging. It also rves as the standard for inspection and licensing of premis for condary packaging of pharmaceutical products.
SCOPE
This guide applies to licend manufacturers only authorid to conduct condary packaging of pharmaceutical products in Hong Kong.
GLOSSARY
Secondary packaging
A manufacturing step involving the labelling, re-labelling, cartoning, re-cartoning or adding additional information (including inrts) to pharmaceutical products which are already enclod in the container in which they are to be sold or supplied.
Reference sample
A sample of a batch of starting material, packaging material or finished product which is stored for the purpo of being analyd should the need ari during the shelf life of the batch concerned. Retention sample
A sample of a fully packaged unit from a batch of finished product. It is stored for identification purpos. For example, prentation, packaging, labelling, patient information leaflet, batch number, expiry date should the need ari during the shelf life of the batch concerned.
Marketing authorisation
An authorisation (e.g. a registration certificate) to market a pharmaceutical product through registration with the Pharmacy and Poisons Board. For pharmaceutical products intended for export only, marketing authorisation has the corresponding meaning associated with the overas regulatory authority.
Starting material
Any substance ud in the condary packaging of a pharmaceutical product, but excluding packaging materials.
1.QUALITY MANAGEMENT
1.1Companies carrying out condary packaging of pharmaceutical products should establish
and maintain a Quality Management System tting out responsibilities, organisational
structure, resources, process, procedures and other activities necessary to ensure
confidence in the quality of the products relead for sale or distribution after the
condary packaging operation.
1.2The Quality Management System should be fully documented and its effectiveness
monitored.
1.3The management should appoint a Quality Assurance Officer who should have defined
responsibilities for ensuring that a Quality Management System is implemented and
maintained.
1.4The Quality Management System should ensure that:
a.managerial responsibilities are clearly specified;
b.a system is established and maintained to approve suppliers of packaging materials to
be ud in condary packaging.
c.all necessary in-process controls, qualifications and validations are carried out;
d.the finished product is correctly packaged and checked, according to the defined
procedures;
demonstrate that all the steps required by the defined procedures and instructions
were in fact taken and that the quantity and quality of the product was as expected.
Any significant deviations are fully recorded and investigated;
products is formally assd against specification. Product asssment includes a
review and evaluation of relevant packaging documentation and an asssment of
deviations from specified procedures;
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g.pharmaceutical products are not sold or supplied before the Quality Assurance Officer
has certified that each packaged batch has been procesd and controlled in
accordance with the requirements of the marketing authorisation and any other
regulations relevant to the packaging, control and relea of pharmaceutical products;
h.satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical
products are stored, distributed and subquently handled so that quality is maintained
throughout their shelf life;
i.the distribution (wholesaling) of the products minimis any risk to their quality;
j.there is a procedure for lf-inspection and/or quality audit, which regularly apprais the effectiveness and applicability of the quality management system;
k.a system of change control is in place to document and manage any changes that may impact the quality of the final product; and
l.appropriate corrective actions and/or preventative actions (CAPA) are taken (and documented) in r
espon to investigations of deviations, suspected product defects
and other problems.
1.5Quality risk management is a systematic process for the asssment, control,
communication and review of risks to the quality of the medicinal product. It can be
applied both proactively and retrospectively.
1.6The quality risk management system should ensure that:
–the evaluation of the risk to quality is bad on scientific knowledge, experience with the process and ultimately links to the protection of the patient;
–the level of effort, formality and documentation of the quality risk management process is commensurate with the level of risk.
2.PERSONNEL
General
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2.1The company should have an adequate number of personnel with the necessary
qualifications and practical experience.
2.2The company must have an organisation chart. People in responsible positions should
have specific duties recorded in written job descriptions and adequate authority to carry
out their responsibilities. Their duties may be delegated to designated deputies of a
satisfactory qualification level. There should be no gaps or unexplained overlaps in the
responsibilities of tho personnel concerned with the application of Good Manufacturing
Practice.
Key Personnel
2.3Key personnel includes the Person-in-charge of Secondary Packaging and the Quality
Assurance Officer. They must be independent from each other.
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2.4The Person-in-charge of Secondary Packaging generally has the following responsibilities:
< supervi the condary packaging operations;
< ensure that products are packaged and stored according to the appropriate
documentation in order to obtain the required quality;
责任制c.to approve the instructions relating to packaging operations and to ensure their strict
implementation;
< ensure that the packaging records are evaluated and signed by an authorid
personnel after the packaging operation;
< check the maintenance of premis and equipment;
女排主教练f.to ensure that the required initial and continuing training of his/her department
personnel is carried out and adapted according to need.
2.5The Quality Assurance Officer generally has the following responsibilities:
< ensure the company‟s Quality Management System is implemented and maintained;
< approve or reject, as he/she es fit, starting materials, packaging materials, and
finished products;
< evaluate batch records;
< ensure that all necessary testing or checking is carried out;
大象用英语怎么说e.to approve specifications, sampling instructions, test methods and other Quality Control
procedures;
< ensure that the appropriate qualifications and validations are done;
< certify that each packaged batch of pharmaceutical product has been procesd and
checked in accordance with this GMP guide before the batch is relead for sale or
distribution;
最后的挽留
< ensure that the required initial and continuing training of his/her department
personnel is carried out and adapted according to need.
< approve and monitor suppliers of packaging materials;
< approve contract agreements;
< coordinate lf-inspections, handling of complaints and recalls;
2.6The Person-in-charge of Secondary Packaging and the Quality Assurance Officer generally
have some shared, or jointly exercid, responsibilities relating to quality. The may
include:
a.the authorisation of written procedures and other documents, including amendments;
学生自主学习b.the monitoring and control of the packaging environment;
