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Saturday, July 10, 2021

STANDARD OPERATING PROCEDURE FOR HANDLING OF EXTERNAL SAMPLES

1.0 OBJECTIVE

1.1 To laydown a procedure procedure for Handling of External samples.

2.0 SCOPE

2.1 This procedure applies to the Pharmaceutical Manufacturing Facility of ________________________________________

3.0 RESPONSIBILITY

3.1 Chemists – Quality Control

4.0 ACCOUNTABILITY

4.1 Head – Quality Control

5.0 PROCEDURE

5.1 Any external samples include but not limited to

5.1.1 Other unit samples

5.1.2 Other R & D samples

5.1.3 Any innovator sample

5.2 All the external samples received to be assigned A. R. No. as follow and enter the details.

5.2.1 MM080001

08 – Represents year in which sample received

MM – Represents external samples.

0001-Is the serial number.

5.3 After completion of analysis, follow the SOP for destruction of the sample after analysis.

6.0 ABBREVIATIONS

6.1 B. No – Batch number

6.2 A.R.No – Analytical Reference number

6.3 Mfg / Exp.date – Manufacturing / Expiry date

6.4 QC – Quality control

7.0 ANNEXURES

NIL

                                                        END OF THE DOCUMENT

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