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 ID: 377727
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Slide1
Management of Quarantine and Reject MaterialsSlide2
Overview
Introduction
Scope
Glossary
Responsibilities
The RequirementsSlide3
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.Slide4
Scope
This presentation applies to company manufacturing sites and distribution centres
This presentation applies to all goods in and storage areas
All storage conditions.Slide5
Glossary
QUARANTINE
: The status of materials, intermediates or products that are:
Isolated
Withheld from use
Pending a decision on their release, rejection, reprocessing or reworkingSlide6
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.Slide7
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.Slide8
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.Slide9
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.Slide10
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.Slide11
Thank You
Any Questions