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General Instructions for Instruments in Pharmaceuticals (SOP)

by KBS.

General Instructions for Instruments in Pharmaceuticals (SOP) emphasizing the importance of proper instrument handling and usage to ensure accuracy, reliability, and safety.

INTRODUCTION

Identification and analysis of different product are made by different technique either by physical or chemical method, involving a specified machinery called Instrument are used at different stages of the product up to finished form.

INSTRUMENTAL METHOD

The method dependent upon measurement of an electrical property and those based upon determination of the extent to which radiation is absorbed or upon assessment of intensity of emitted radiation, all require the use of suitable instrument e.g. Polarimeter, Spectrophotometer etc. and in consequence such method are referred to as INSTRUMENTAL METHOD. Each person working in the lab needs to aware the general introduction to each and every instrument before operating the instrument.

PURPOSE

Means for what purpose it is used e.g.

  • UV Spectrophotometer for qualitatively and quantitative analysis of substance.
  • pH meter to check the acidity and alkalinity of the sample under test (in liquid form) to control the pH within specified limit.
  • Basic technique to handle the instrument
  • What instrument precautions are necessary during operating the instrument.
  • Calibration
  • Cross-checking of the result to verify it.

OPERATING INSTRUCTIONS

The qualified person working in laboratory is responsible to ensure that equipment, apparatus and device used for the analysis are capable of consistently operating properly within acceptable tolerance limits.

Written procedure i.e. SOP are established and followed that include equipment calibration, annual maintenance, monitoring and control. A routine maintenance check is documented. Qualified person through a specific training and experience to operate or manipulate any item of equipment, apparatus, or device to which they are assigned to use when preparing drug product for patients. Training include the ability to determine whether any item of equipment is operating properly or is malfunctioning (e.g.) operating instruction for U.V. Spectrophotometer.

  • Proper electrical supply
  • Switch on the U.V Spectrophotometer
  • Base line correction
  • Operating procedure as per SOP’s of related sample under test
  • SOP’s report i.e. documented the result in file (record) of relative sample under testing
  • Entries of result in BPR (Batch Production Record).

CALIBRATION

PURPOSE

  • All instruments should be calibrated and appropriate correction applied to the original measurement. Thus, a calibration system should bring about trust in decision or measures.
  • To avoid the variation.
  • To achieve the result according to the specification.

CALIBRATION PROCEDURE

  1. As per specification of each instrument
  2. Each instrument calibrated daily basis, monthly basis or quarterly basis e.g. pH meter, Electrical balance, UV Spectrophotometer and IR Spectrophotometer respectively.
  3. Contact with Calibration Contractor
  4. Calibration reports along with signature, date, time and of person calibrating it.
  5. Cross-checking by quality control supervisor.

Calibration and Maintenance Schedule

Following instruments are maintained by our contract with Technology Links.

S. No. Name of equipment’s Model & Company Daily Weekly Monthly   Two month Quarterly Six month Annually
1 HPLC *
2 U.V. 3 3 *
3 FTIR 3 *
4 Dissolution Rate Tester *
5 Disintegration Tester *
6 Polarimeter 3 *
7 Refractometer 3 *
8 Distillation Assembly *
9 Viscometer *
10 PH meter 3
11 Density meter 3
12 Melting point 3
13 Analytical balance 3
14 Analytical balance
15 Microscope *
16 Laminar flow bench
17 K.F.
18 Sonicator 3 **
19 Autoclave
20 Hot Plate ***

* Maintenance and calibration done by a contractor at the time of service.
** Calibration done at the time of analysis
*** Not assembled yet.

CALIBRATION RECORD:

Each instrument has separate calibration record file. In which the results of calibration are documented.

Storage of calibration record file:

Just below the cabinet where the instrument is installed.

Calibrating tools.

  • Reagents are substance used either such or as constituents of solution. Pot. Dichromate “use in U.V. calibration.
  • Standard tablets for dissolution test calibration
  • Salicylic acid tablets 300mg (delayed release) USP
  • Prednisone tablets 50mg (quick release) USP
  • Cimetidine tablets (USP)

CALIBRATION LABEL

CALIBRATION
Instrument_____________________________ Model NO. ______________________Calibrated on_________________                    Due Date    _______________________Calibrated By________________________     QCM          _______________________
PAKISTAN LIMITED
Calibration label pasted on the right side of each instrument.

INSTRUCTION MANUAL OF THE MANUFACTURER

PURPOSE
  1. Complete reading of the instruction manual of the manufacturer before dealing with instrument to avoid the mishandling.
  2. To understand the function of different keys.
  3. Fault finding

ENVIRONMENT

Clean environment

Weekly microbial monitoring program:

Weekly microbial monitoring program consisting of multiple test to determine the baseline Count and subsequently reduced testing for ongoing maintaining of the environmental control condition.
Procedure
By Swab method
  1. Take a cotton swab
  2. Mopped it on instrument surface
  3. Then dip the swab on the media
  4. Incubate the media
  5. Calculate the microbial count
  6. Prepare the report
To ensure good service life and performance of the equipment, do not install near a source of electrical noise.
Also avoid location where dust or corrosive gases are present.

VENTILATION AND CAUTION ON FIRES

Sufficient ventilation of room is absolutely necessary when carrier liquid is inflammable or when using toxic solvent.

TEMPERATURE CONTROL

In the higher temperature of the environment, result will fluctuate from limited range e.g. in case of pH meter, Viscometer, Spectrophotometer, HPLC, I.R etc.

STORAGE

The condition of storage should be proper for machines as required.
  1. Protect from direct sun light
  2. Control of temperature with centrally air conditions plant below 30°C
  3. Control of humidity with hygrometer.
  4. Microbial control with regular mopping of laboratory or fumigation with disinfectant
  5. phenyl 5% finis
  6. chloroxylenol 2% Dettol for longer life of the instrument.
  7. Proper place for installation
  8. After use cover instruments properly

PRECAUTION INCLUDING PERSONAL SAFETY

Before going the laboratory or dealing with instrument the precaution are required as per GMP  should be strictly follow for personal safety.
Purpose:
  1. Use of Mask while dealing with toxic chemicals.
  2. Use of Gloves to avoid any skin damage and to achieve the accuracy of the result
  3. Use the Glasses to protect the eyes from the fumes of dangerous gases like HCl and
  4. H2SO4 always open the exhaust while dealing with gases.
  5. Use of Coat & Caps for personal safety.

ARCHIVING

The original SOP’s is to be archived in such a way that they are protected from unauthorized use. It is stored on computer in which a priority system is established that allows access only to members of the Quality Control Department (including persons authorized by them). Storage of SOP’s in the computer network is permitted under strict adherence to the rights of access and the original print of SOP’s will be store for 5 years in Quality Control Manager office.

TRAINING

Periodical Training:
The staff, that is responsible for performance of this operating instruction, has to be taught demonstrably about the content of this SOP together with the GMP training once in a year.
Training for New Employees:
Before starting with the job, the employee has to be taught demonstrably about the content of this SOP.

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