Handling And Testing Of In-Process Sample\

 

1.0  OBJECTIVE:

To clearly lay down procedure for handling and testing of in-process sample.

2.0  SCOPE:

This procedure is applicable to the in-process samples of formulation such as granules core tablet etc.

3.0  RESPONSIBILITY:

3.1  Doing: Tech. Asst. /Executive.

3.2  Checking: Executive/ Asst. Manager/ Manager.

4.0  ACCOUNTABILITY:

4.1  Head of the Q.C Department.

5.0  PROCEDURE:

5.1  On receipt of in-process sample along with in-process test request slip from manufacturing dept., Q.C will allot Q.C REPORT No. as per below. X0Y/000Z.

5.1.1        For in-process sample from Tablet allot numbering where X= G.

5.1.2        For in-process sample from capsule allot numbering where X= M.

5.1.3        0Y= Year of sample receipt i.e. = 03 for year 2003, 04 for year 2004 etc.

5.1.4        000Z= serial number staring from 0001…. 

5.2  Make the entry respectively in in-process register with following details.

5.2.1        Sr. No.

5.2.2        Batch No.

5.2.3        Q.C. A.R. No.

5.2.4        Mfg. Date.

5.2.5        Exp. Date.

5.2.6        Batch Size.

5.2.7        Date of Receipt

5.3  Distribute data sheet as per Annexure.

5.4  After completion of entry, put the sample in to “UNDER TEST SAMPLE” tray.

5.5  Q.C section in-charge/ Executive shall distribute the sample along with intimation slip and data sheet to the chemical section and instrument section for respective analysis.

5.6  Chemist shall analyse the sample as per respective method of analysis and record the results in data sheet & similarly enter results in SAP system.

5.7  On completion of testing, give report to Q.C section in-charge/ Executive for checking.

5.8  Q.C section in-charge/ Executive shall check the results of chemical and instrument testing.

5.9  Sign the report.

5.10       Q.C section in-charge/ Executive enter the results into respective in-process entry register.

5.11       After completion of entry, Q.C section in-charge/ Executive will fill the results in the In-process sample test request slip in duplicate and will put their sign in it.

5.12       Q.C section in-charge/ Executive will send Blue slip to production and attach the yellow slip with testing report.

5.13       In absence of responsible person, technical assistant shall convey the results to production dept. along with in-process sample test request slip.

5.14       After completion of testing, destroy the sample as per SOP.

5.15       File the report in to respective file.

5.16       Note: Allotting Q.C Report No. after completion or before completion of analysis.

6.0  REVISION LOG:

Revision No.

Effective Date

Reason

00

 

New SOP

 

7.0  REFERENCES:

7.1  Not Applicable.

8.0  ANNEXURES:

8.1  Not Applicable.

9.0  ABBREVIATIONS:

Abbreviation

Expanded Form

S

Standard operating procedure

&

And

%

percentage

Tech.

Technical

Asst.

Assistant

Sr.No.

Serial number

A.R. No.

Analytical report number

Mfg.

Manufacturing

Exp.

Expiry

SAP

Systems applications & products

 

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