1.0
Objective:
To provide written procedure for Laboratory control
mechanism and maintenance of Laboratory records
2.0
Scope:
This SOP covers all the activities of Company Name .
3.0 Responsibility:
Jr. Research Officer/ Research
officer:
Aware about the calibration of instrument and
specification & method of analysis. Analyze the sample and record the
observation, prepare the raw data.
QA Officer/Manager:
Evaluated the all data and
release or rejects the sample.
General Manager/Director:
Authorized the final test
report.
4.0 Procedure:
4.1 GENERAL LABORATORY CONTROL:
4.1.1 Laboratory control mechanism
shall include the establishment of scientifically sound and appropriate
specifications, standards, test procedures designed to assure that materials
confirm to appropriate standards of identity, quality and purity.
4.1.2 Laboratory control
mechanisms also include the calibration of instruments, apparatus, and
recording devices at suitable intervals
in accordance with the written program containing specific directions, limits
of accuracy and precision and provision for remedial action in the event of limits
not being met.
4.1.3 Procedure shall be
prepared for preparation of standard solutions and standard operating
procedures for equipments and calibrations.
4.1.4 The test procedures
shall apply to testing of materials as per requirements.
4.1.5 Testing and release shall be done as per the written and approved
specifications and test procedures or pharmacopoeia.
4.1.6 All the master specifications, standard testing procedures and standard
operating procedures shall be reviewed at least once in two years.
4.1.7 Director shall approve all the standard operating procedures.
4.2 LABORATORY RECORDS:
4.2.1 On receipt of a sample for testing record the details of
the same in the sample entry registers and allot Booking number or A.R. number
(Analytical report number).
Allotment of A. R. No.
Where, XXX = Company name .
00001
= Serial Number of received Sample
01-02
=
01-02 stands for year 2001-2002
4.2.2 Validation samples: XXX/VAL / 001/01-02
Where, XXX = Company name
001 = Serial Number of received Sample
01-02 = 01-02 stands for year 2001-2002
4.2.3 Water samples: XXX/
00001/ WAT//01-02
Where, XXX = Company name
00001 = Serial Number of received Sample
WAT =
Water Sample
01-02 = 01-02
stands for year 2001-2002
4.2.4 Packaged Drinking Water samples: XXX/
0001/ PDW//01-02
Where, XXX = Company name
0001 = Serial Number of received Sample
PDW =
Packaged
Drinking Water
01-02 = 01-02 stands for year 2001-2002
4.2.5 Working standards: XXX/WS/001-00
Where, XXX = Company name WS = Working Standard
001 = Working Standard number
00 = Year
4.2.6 Primary standards: XXX/PS/001-00
Where, XXX = Company name
PS = Primary Standard
001 = Primary
Standard number
00 = Year
4.2.7 Volumetric Solution: XXX/VS/001
Where, XXX = Company name
VS = Volumetric
Solution
001 = Volumetric Solution Number
4.3 Record all the data generated during analysis, and record the complete
data.
4.4 Use only black ballpoint pen to record the details. Attach all the graphs
and spectra from instrument (whenever applicable) to the data sheet.
4.5 Sign every page of the datasheet at the bottom portion at the left side.
4.6 After completion of the analysis and completion of data, fill up the
worksheet; checked the protocol showing all findings recorded in the worksheet along with the
specification limits
4.7 Finally computerized
test report are authorized by General Manager (Technical)/ Director.
4.8 All records shall be maintained for a period of 3 years.
5.0 History
of Revision:
Revision No.
|
Effective
Date
|
Revision
details
|
Reason for
revision
|
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