SOP FOR SAMPLING, TESTING AND RELEASE OF INPROCESS SAMPLES

  1. OBJECTIVE:

    1. To lay down the procedure for the Receipt, Testing and Release of In-Process samples.

  2. SCOPE

    1. This procedure is applicable for the Receipt, Testing and Release of In-Process samples.

  3. RESPONSIBILITY:

    1. Quality Control Officer / Executive are responsible for Receipt & testing, follow procedure as per the procedure mentioned in this SOP. 

    2. QC Head is responsible for Approval & Release and implementation and compliance of the procedure as per this SOP.

  4. ABBREVIATIONS

    1. SOP    :    Standard Operating Procedure

    2. QC    :    Quality Control

    3. COA    :    Certificate of Analysis

  5. PROCEDURE

    1. After receiving the samples and test request from Production, enter the details in Inward Record For Inprocess Samples (Annexure I) and allot an analytical reference number.

    2. QC chemist shall analyze the sample and enter the data and calculations in the test data sheet as per Test Data Sheet (Annexure II).  

    3. The Test data sheet format consists of the following information in the respective cells of the format as given in Annexure II.



Cell Number

Information

01

To write the name of product

02

To write reference /Specification no.

03

To write Batch  number

04

To write the A.R. No. 

05

To write the stage 

06

To write the batch Size 

07

To write the date of  manufacturing

08

To write the date of  Expiry 

09

To write the date of the sampling

10

To write the sample quantity

11

To write the date of analysis 

12

To write the date of release

    1. The results of the tests carried out shall be entered in the request form and duplicate copy of the same shall be sent to production. All the data and COA shall be made.

  1. ANNEXURES/REFERENCES :

    1. Annexure I : Inward Record For Inprocess Samples

    2. Annexure II : Bulk/Blend  Data Sheet

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