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LABORATORY PROCEDURES FOR ANIMAL & HUMAN CELL LINES

REFERENCE NO: AHC/1998/4/4.3


TITLE: PRODUCT RECALL PROCEDURE


INTRODUCTION

The purpose of this protocol is to describe the procedures to be followed in the event of the recall of a batch of product manufactured within collection or the request that a customer discards a product manufactured within the collection.

PROCEDURE

  1. The Head of Department shall be responsible for authorising a product recall or discard.
  2. A cell line may be recalled due to :
  • poor viability
  • mycoplasma contamination
  • cross-contamination
  • incorrect labelling.

A cell culture product may be recalled due to:

  • microbial contamination
  • denaturation of product

NB In the event of any of the above, it is more usual to request the cell line or product to be discarded by the customer in an appropriate manner.

  1. Notification of recall or discard shall include:
  • The name and quantity of the product
  • The batch number (where appropriate)
  • The nature of defect
  • The action to be taken

 


Guidelines prepared for CABRI by CERDIC, DSMZ, ECACC, INRC, November 1998
Page layout by CERDIC
Copyright CABRI, 1998

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