SOP for Handling and Testing of Inprocess Sample

1.0 OBJECTIVE

To clearly lay down procedure for handling and testing of inprocess 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

Head of the Department

5.0 PROCEDURE

5.1 On receipt of in-process sample along with in-process sample test request slip from manufacturing department, Q.C will allot Q.C Report no. as per below X0Y/000Z
For in process sample from Tablet allot numbering where X= G
For in process sample from capsule allot numbering where X= M
For in process sample from parenteral allot numbering where X= B
0Y= Year of sample receipt i.e = 03 for year 2003, 04 for year 2004 etc.
0000Z= serial number staring from 0001….
5.2 Make the entry respectively in in-process register with following details.
A. Sr.No.
B. Batch No.
C. Q.C.A.R.No.
D. Mfg .Date
E. Exp. Date
F. Batch Size
G. 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 Incharge/Executive shall distribute the sample along with intimation slip and Data Sheet to the Chemical section, Instrument section & Microbiology 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 Incharge/Executive for checking.
5.8 Q.C Section Incharge /Executive shall check the results of chemical, instrument and microbiological testing.
5.9 Sign the report.
5.10 Q.C Section Incharge/Executive enter the results into respective inprocess entry register.
5.11 After completion of entry, Q.C Section Incharge /Executive will fill the results in the ‘Inproces Sample test request slip in duplicate and will put their sign in it.
5.12 QC Section Incharge/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 department 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
Note: Allotting Q.C Report No. after completion or before completion of analysis.

6.0 ABBREVIATIONS

6.1 Q.C = Quality Control
6.2 Q.C.A.R.No.= Quality control analytical report number
6.3 Sr.No.= Serial no.
6.4 Mfg. Date = Manufacturing date
6.5 Exp. Date = Expiry date
6.6 SAP = System Application Procedure

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