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SOP for General Laboratory and Control Records

Objective
To provide a written procedure for Laboratory control mechanism and maintenance of Laboratory records

Scope
This SOP covers all the activities of Pharmasky Ltd.

Responsibility
QC officer: Aware of the calibration of instrument and specification & method of analysis. Analyze the sample and record the observation, prepare the raw data.
QCManager: Evaluated all data and released or rejects the sample.

Procedure

General Laboratory Control
  • 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.
  • 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.
  • Procedure shall be prepared for the preparation of standard solutions and standard operating procedures for equipments and calibrations.
  • The test procedures shall apply to testing of materials as per requirements.


  • Testing and release shall be done as per the written and approved specifications and test procedures or pharmacopoeia.
  • All the master specifications, standard testing procedures and standard operating procedures shall be reviewed at least once in two years.
  • QA Manager shall approve all the standard operating procedures.

Laboratory Records
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. is as follows: XXX/00001/01-02
Where, XXX = Company name .
00001 = Serial Number of received Sample
01-02 = 01-02 stands for year 2022-2023


Validation samples: XXX/VAL / 001/01-02
Where, XXX = Company name
VAL = Validation Sample
001 = Serial Number of received Sample
01-02 = 01-02 stands for year 2022-2023


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 2022-2023


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 2022-2023


Working standards: XXX/WS/001-00
Where, XXX = Company name 
WS = Working Standard
001 = Working Standard number
00 = Year 23


Primary standards: XXX/PS/001-00
Where, XXX = Company name
PS = Primary Standard
001 = Primary Standard number
00 = Year 23


Volumetric Solution: XXX/VS/001
Where, XXX = Company name
VS = Volumetric Solution
001 = Volumetric Solution Number


  • Record all the data generated during analysis, and record the complete data.
  • Use only a black ballpoint pen to record the details. Attach all the graphs and spectra from an instrument (whenever applicable) to the datasheet.
  • Sign every page of the datasheet at the bottom portion at the left side.
  • 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
  • Finally, computerized test reports are authorized by General Manager (Technical)/ Director.
  • All records shall be maintained for a period of 3 years.

Abbreviation
QC: Quality Control
QA: Quality Assurance

Revision History
Nil


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