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
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
Hi. I’m Writer of Researchsop.com. ’ ’ Please share these SOPs to all concern pharma people for their development. I like to fullfill the need of curious people. These things inspire me to make things looks better.
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