Handling And Testing Of Various Samples

 

1.0  OBJECTIVE:

To clearly lay down procedure for handling and testing of various samples.

2.0  SCOPE:

This procedure is applicable to various samples such as MISCELLANEOUS, VALIDATION & STABILITY SAMPLES for analysis at Q.C.

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 various sample along with in-process sample test request slip or various correspondence from various sites, Q.C will give Q.C REPORT No. as per below. X0Y/000Z.

5.1.1        For sample received from VALIDATION allot numbering where X= VA.

5.1.2        For sample received from MISC. (Other than insulin) allot numbering where X= MIS.

5.1.3        For sample received from STABILITY numbering where X= STB.

5.1.4        0Y= Year of sample receipt i.e. = 01 for year 2001, 05 for year 2005 etc.

5.1.5        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 samples along with testing slip.

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

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

5.6  Chemist shall analyse the sample as per respective method of analysis & specification and record the results in testing sheet.

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

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

5.9  Sign the report.

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

5.11          After completion of entry, Q.C in-charge/ Executive shall convey the result to respective dept.

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

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

5.14          File the report in to respective file.

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

&

And

No.

Number

No.

Number

Sr.No.

Serial number

A.R. No.

Analytical report number

Mfg.

Manufacturing

Exp.

Expiry

 

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