The
quality of packaging material is a critical factor
in assuring the safety and efficacy of medicines.
Various problems that may arise from inadequate
quality range from the disastrous mix-up of carton,
label, or leaflet capable of causing patient harm,
through seemingly minor cosmetic physical defect,
which can still undermine patient's confidence
in their medicines.
Despite
all the precaution taken, a significant proportion of
safety recalls of medicines from the market are caused
by faulty packaging.
What
is PS 9000?
With
this background in mind the IQA and PQG CoP developed
PS 9000- pharmaceutical packaging materials which accommodate
the standards and technologies to control quality of
packaging material. The standard developed was PS 9000
which is applicable to the suppliers of:
Cartons
Labels
Leaflets
Foils
Stripes
to Pharmaceutical Industry
Potential
Benefits
A
single standard and a protocol that allows an evaluation
by third party certification bodies.
The
standard is comprehensive in scope covering areas
of GMP (Good Manufacturing Practices) Guidelines,
quality and product safety throughout the packaging
industry.
The
standard addresses part of the “due diligence”
requirement of the packaging industry
Standard
Requirements
QA/PQG
pharmaceutical suppliers code of practice
Requirements
for GMP and
The
requirement text of ISO 9001 and the guidance text
of ISO 9004
Salient
Features
Salient
Features of the Standard are as follow:
Gang
printing (the process of printing more than one
design on a substrate at one production run) is
not permitted because of the risk of ad mixture.
Security
barcode item shall be verified by online scanning
equipment
Facilities
shall be operated and provided maximum protection
from the entry of rodents, pests, birds or flying
insects into the manufacturing and storage area
Role
of Investè
Investè
shall determine the current practices of the organization
in perspective of design, development (PDD and Prepress)
processing and dispatch of packaging material, the current
controls to prevent admixture and contamination of the
product and carry out a brief study and assessment of
current GMP and hygiene practices.
Investè
shall design and conduct training sessions to understand
the functional, hygiene and safety aspect of the
packaging material.
Recommendation
of changes to process and layout shall be conveyed
to the top management. Investè shall also
advise on other measures to be taken.
On determination
of the Gaps and other feedbacks during the training,
Investè shall draw up the architecture of
process documentation and assist the clients to
document their processes.
Investè
shall train the staff for internal audit and assist
the client to carry out internal audits.
Overview
