Management of
Quarantine and
Reject Materials
Overview
• Introduction
• Scope
• Glossary
• Responsibilities
• The Requirements
Introduction
• All sites must implement systems and
procedures to assure that returned,
rejected, recalled and quarantined raw
materials, active pharmaceutical
ingredients, intermediates, pharmaceutical
products, packaging components and
medical devices are controlled to prevent
improper use or release.
Scope
• This presentation applies to company
manufacturing sites and distribution
centres
• This presentation applies to all goods in
and storage areas
• All storage conditions.
Glossary
• QUARANTINE: The status of materials,
intermediates or products that are:
Isolated
Withheld from use
Pending a decision on their release, rejection,
reprocessing or reworking
Responsibilities (1)
• Site Quality is responsible for approving or rejecting or
quarantining all products and materials in a timely
manner
• Site Quality is responsible to communicate the
decision to affected departments
• Managers from manufacturing, logistic, distribution,
warehouse units are responsible for:
 the proper control of returned, rejected, recalled and
quarantined materials
 assuring that systems and procedures are in place to
comply with the requirements of the site Quality Unit.
Responsibilities (2)
• Managers
from
manufacturing,
logistic,
distribution, warehouse units, acting upon
decisions from site Quality are responsible for:
 The appropriate and timely disposal/destruction of
returned, rejected and recalled/recovered materials
• Health Safety Environment must be consulted if
appropriate
• Site Quality is responsible for review and approval
of those systems and procedures.
Requirements (1)
• Each site must have procedures to define quality
status in use. Status categories must be as a
minimum: Quarantined, Approved, Rejected
• Incoming materials, returned goods and recalled
products must be placed under Quarantine status.
These materials may have an alternative status:
unreleased or on-test. Such status bears same
restrictions as quarantined
• Site Quality must approve all status changes
according to related procedures.
Requirements (2)
• Status of products and materials must be clearly
identified at all times
 Physical segregation : separate cage storage or separate shelf
 Use of adequate status labelling or electronically with validated
and controlled « electronic segregation » system (barecode
reading)
• Rejected materials, returned products and recalled
products must be stored in secured, physically
segregated and labelled/identified areas
 Automated warehouse: validated and controlled « electronic
segregation » system with no routine personnel access may be
used.
Requirements (3)
• All rejected material must be status labelled
• Site Quality must perform review of quarantined
and rejected materials (at least quarterly basis)
 Assure the timely disposition of quarantined materials
and disposal and documenting all disposed materials
• Safety requirements regarding segregation and
control for controlled substances or materials must
be in place.
Thank You
Any Questions