SOP for Testing of Miscellaneous Samples : Pharmaceutical Guidelines

SOP for Testing of Miscellaneous Samples

Standard operating procedure of testing of miscellaneous samples in Quality Control.

1.0 OBJECTIVE

To describe the procedure for testing of the miscellaneous sample.

2.0 SCOPE

This SOP is applicable for the testing of the miscellaneous sample.

3.0 RESPONSIBILITY

Officer/ Executive - Quality Control

4.0 ACCOUNTABILITY

Manager – Quality Control

5.0 PROCEDURE

5.1 Sampling information (advice) for the sampling of any miscellaneous items has to be generated by QA department / another party.
5.2 Sampling advice shall be forwarded to QA for sampling provided to quality assurance representative.
5.3 Quality assurance dept. representative shall collect the sample from respective location.
5.4 Miscellaneous sample shall be sent to quality control dept.
5.5 Quality control dept shall record the details of the sample in the miscellaneous sample testing record as per Annexure- I.
5.6 QC head should assign the work to chemist/supervisor and inform the results to QA head.
5.7 Follows the test as per STP / Standard specification, and maintain the raw data in the supplementary sheet.

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure
6.2 No. - Number
6.3 QA - Quality Assurance
6.4 QC - Quality Control
6.5 CCF - Change control format

ANNEXURE-I
MISCELLANEOUS /SUPPLEMENTARY RECORD
Date
Material / Product Name
    Batch No.
Raw data 
sheet No.

Analyzed by

Remarks

























ANNEXURE-II 
MISCELLANEOUS /VENDOR SAMPLE TESTING RECORD
     Date 
Material / Product Name
   Batch No.
A. R. No.
Raw data sheet No.
Tested  by
Remarks

































Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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