ISSUE, CONTROL AND UPDATING OF LABORATORY PROCEDURES

LABORATORY PROCEDURES FOR PHAGES

REFERENCE NO: PH/2003/01/07

TITLE: ISSUE, CONTROL AND UPDATING OF LABORATORY PROCEDURES

INTRODUCTION

All procedures carried out in any laboratory should have a formal protocol available for reference purposes. The methods described in the laboratory procedure documents should be strictly adhered to. Risk assessments should be referenced according to national and European regulations.

PROCEDURE

All methods should be written down clearly and concisely giving easy to follow stepwise instructions. The procedures should be written in the language of the collection staff. Instructions for procedures used by non-native persons should also be available in English.

Procedures should then be passed to the person responsible for the control of laboratory procedures (PRCLP) in the collection. The PRCLP may make proposals to change, to amend or to reject a procedure.

After the procedure has been accepted, the PRCLP will assign a unique identification number to the procedure. This may be collection-specific with respect to the details of this responsibility.

Then the procedure should be passed to the head of the collection or to a person designated by the head for signature. This can be the responsibility of the quality manager if there is one.

A list of recipients of signed procedures and document locations is retained by the PRCLP.

All procedures concerning a laboratory should be placed in clearly identified files which also contain an inventory of all procedures. The files should be available in that laboratory.

All procedures of the collection and an inventory of all procedures have to be found in the collection office and must be stored as computer files.

Proposals to amend a procedure should be forwarded to the PRCLP. Revised copies will be produced as described in paragraph 4 above, signed and issued. Earlier copies are made invalid but are kept for a further period as defined by the collection.

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