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properly documenting and monitoring
these relationships.
- Not giving gifts or other items of
value to induce business or influence
outcomes.
Product Quality and Patient Safety
Schering-Plough is committed to the
highest manufacturing standards for
our products to ensure product quality
and patient safety, which are critical to
achieving our mission to earn the trust
of doctors, patients, customers and
regulatory agencies. They should
expect no less from Schering-Plough.
We will meet these expectations through
consistently effective execution of our
global quality policies and standards,
which are designed to ensure
compliance with all applicable
governmental quality and safety
requirements.
This means:
- Following all government requirements,
including good manufacturing
practices, and all applicable Company
quality policies and worldwide quality
standards.
- Adhering to local standard operating
procedures for the quality control and
quality assurance of raw materials,
manufacturing processes, testing,
storage, handling and shipping of
our products.
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Product Quality and Patient Safety
Q. A manufacturing supervisor
has told us not to notify Quality
Assurance about a deviation from
the manufacturing instructions
that occurred during the
manufacturing of a batch.
She said that “we can handle it
internally without anyone else
being involved.” I think this
violates Company policy, but she
is the supervisor. Should I just
follow orders and ignore this?
A. No. If you think that the
supervisor is giving instructions
that are contrary to the current
Good Manufacturing Practices
(cGMP) regulations or our
internal policies and procedures,
and you do not feel comfortable
talking with your supervisor
directly, contact your supervisor’s
manager, your facility’s Quality
Assurance department, or the
Integrity Action Line.
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