Title: Approval of Contract Testing Laboratory Results

Approval of Contract Testing Laboratory Results

1.0 OBJECTIVE

To describe the procedure for approval of contract testing laboratories results .

2.0       SCOPE

This procedure is applicable to the various tests that are carried out at Contract Testing Laboratory.

3.0 RESPONSIBILITIES

Executive/Office QC: Responsible for prepare the requisition of outside laboratory.

Head – QC: Responsible for the Approval of requisition and compliance of this SOP.       

4.0 DISTRIBUTION

Master Copy   : Quality Assurance Department

Controlled Copy – 1     : Quality Control Department

5.0 PROCEDURE     

5.1 Approval

  • The Contract Testing Laboratory is approved on the basis of their test facilities, approved License and periodic audits performed by QA/QC.
  • The assessment form is prepared. This is to be forwarded to them and data is obtained and kept in the record.

5.2       Testing

  •  The test requisition is prepared by Executive/ Officer Quality control and approved by HOD- QC .
  • The test requirement is clearly stipulated in the requisition.
  • Test sample is properly packed and send to laboratory along with the specifications and testing method where is applicable.
  • On obtaining COA and raw data from contract testing laboratory, raw data shall be reviewed and approved by Quality control with our specification and the test results are compared with the COA submitted by the contract testing laboratory.
  • The contract testing report to be attached with the related records.
  • Upon satisfactory review, the raw data is archived and batch shall be released.

6.0       ABBREVIATIONS

QA       : Quality Assurance

QC      : Quality Control

COA    : Certificate of Analysis

HOD    : Head of Department

No.      : Number

Bhanu Pratap Singh

BHANU PRATAP SINGH IS EXPERIENCED IN PHARMACEUTICAL, AUTHOR AND FOUNDER OF PHARMACEUTICAL GUIDESLINE (WWW.PHARMAGUIDESLINE.COM), A WIDELY READ PHARMACEUTICAL BLOG SINCE 2019. EMAIL:- INFO@PHARMAGUIDESLINE.COM

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