Friday, November 26, 2010

Sending Sample to Contract Lab

Purpose     :  To provide instructions for sending sample to contract lab and evaluation of results.

2.0  Objective   :  To provide a documented procedure for sending sample to contract lab and evaluation. of results
3.0              Scope   :   This procedure for sending sample to contract lab and evaluation of results is applicable for QC Department -----Pharmaceuticals Ltd, 
4.0   Responsibility  :
·     Primary   : QC Officer
·       Secondary  : Overall: Manager QA/QC
5.0  Procedure  :
·     This method is applicable to ------ Pharmaceuticals Ltd,  for the     samples sent to contract lab for analysis.
·     Following procedures are to be followed while sending the sample to the contract laboratory for testing.
Ø      Make sure, while submitting any sample for analysis that the sample container has a proper label with the following details:
o      Name of Material / Product
o      Sampled from,
o      Batch No.
o      Date
Ø      A counter sample must be preserved by the submitter under proper conditions so that the sample does not deteriorate.
Ø      Samples for analysis shall be sent through Manager-QA/QC, no one should forward directly any sample to contract laboratory.
Ø      For any sample going out of the lab, an entry must be made in a separate register maintained for this purpose.
Ø      Adequate care shall be taken for the sample reaching safe and not deteriorate and spillage.
Ø      The request shall be sent along with the sample describing clearly the analysis required and the reference of the Pharmacopoeia. In case the analysis is to be performed by In-house method then the details of the same test (uncontrolled copy) shall be provided to the contract lab.
Ø      A contract with the contract lab shall be written after the audit has been performed and compliance for the deficiencies noticed is accomplished.
Ø      The analytical results shall be provided with the supporting papers viz chromatograms and other tracings, if any.
Ø      On receipt of the analytical results the data shall be reviewed by QA and the acceptance of the same shall be given. In case of any problem the clarification shall be sought from the contract lab.
Ø      For the release of the batches the analytical results shall be collected by Fax or Email as the case may be.
Ø      Maintain the record in sample register for contract lab containing, Date, Sample details, Contract lab name, Analysis required, Sent by, Signature, Results received on, Results evaluated by, Approved/Rejected, Signature and Remarks.
v          Sample Register for contract lab.
Product Name
Batch No.
Sample Qty
Name of Contract Lab


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