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 PharmaInfo 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 rejected the sample.

Procedure

General Laboratory Control

• Laboratory control mechanisms shall include the establishment of scientifically sound and appropriate specifications, standards, and test procedures designed to assure that materials conform 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 equipment and calibrations.
• The test procedures shall apply to the testing of materials as per requirements.

• Testing and release shall be done as per the written and approved specifications and test procedures or pharmacopeia.
• 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

ALSO READ: SOP for Difference between Stability and Release Specification

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; check the protocol showing all findings recorded in the worksheet along with the specification limits
• Finally, computerized test reports are authorized by the 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

ALSO READ: SOP for Out of Calibration of Laboratory Instruments