Management of Quarantine and Reject Materials

Overview Introduction Scope Glossary Responsibilities The Requirements 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. 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 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. 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. 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. 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. 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. 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.

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