Application of Computer in QC

8/3/2019 Application of Computer in QC

1/22

SUBMITTED BY,

C.ULAGANATHAN,

DEPT. PT. OF PHARMACEUTICS,

BHARATHI COLLEGE OF

SEMINAR ON CHEMICAL AND BIOLOGICAL EVALUATION

SUBMITTED TO,Dr. S RAJA,DEPT. PT. OF PHARMACEUTICS,BHARATHI COLLEGE OFPHARMACY.


2/22

APPLICATION OF COMPUTERS

IN QUALITY CONTROL LABCONTENTS:

Parts of computer

Advantage& Disadvantage.

Active application.

Passive application.

Other application.


3/22

COMPUTER is aC=Commonly

O=Oriented

M=Machine

P= ParticularlyU=Used for

T=Technology

E=Education and

R=Research


4/22

Various parts of typical computer:

A computer consists of various hardware components that work together withsoftware to perform various activities.

COMPUTER

INPUT DEVICES

Ex:keyboard mouse etc

OUTPUT DEVICES

Ex:monitor, printer,

speaker

Typical computer components

System Unit

CPU AND MEMORY

Storage DevicesEx. Floppy, CD, DVD..


5/22

A COMPUTER IS AN ELECTRONIC DEVICE WHICH

PERFORMS OPERATION SUCH AS:

COMPUTER TASKS

Accept the data

Process or manipulate the data output the result in the form that suitablefor Human understanding

Stores the input data results..

All these activities are performed based on the instruction that are stored inthe memory of the computer.

All these tasks are performed at tremendous speed & very high accuracy.


6/22

ADVANTAGE:

Easy to use

Simple & accurate

Very fast

Comparison

DISADVANTAGE:

It is very expensive

It fully depends on electricity

Expertization required

Some can lead to damage data

Application with analytical instrument:

ACTIVE APPLICATION

PASSIVE APPLICATION


7/22

ACTIVE APPLICATION

In this computer control the interaction with an instrument . Theoutput from computer control sequence of steps required for the

operation of the instrument.

FOR EXAMPLE:

IN spectroscopy determination the computer may be,

Choose a proper source & Active the source.

Adjusting the intensity of light& Correcting the base line

Allow the radiation to pass through the blank and sample&

control the monochromatic so choose proper wavelength.

Adjust the detector response and record the intensity level.

in addition computer may be programmed to vary the

experimental condition. So quality of the subsequent data is improved.


8/22

Example:2

Adjustment of slit width & wavelength

The temperature of chromatograpic coloumn

The potentiol applied to an electrode

The rate of addition of reagent

The time at which integration peak is to start

Initiate of data collction of a GC-MS instrument


9/22

Computer control can be relatively simple as can

be in this following example:

Determination of concentration of element by atomic

emission involves measurement of the heights of emision

peak, which are found at wave length that are chararectristic

of each element.

In above cause computer can make,

A monochromater to rapidly shift a range of wave length until a peak is

detected.

The rate of shift is then slowed to determine the exact wavelength at which

the height of peak occurs.


10/22

Intensity measurement is made at this point until an average is

obtained that gives a suitable signal to noise ratio.

The computer then causes the instrument to repeat the

experiment for each peak of interest in the spectrum.

Finally the computer calculates and print out the concentrationof element Present, because of its great speed. The computer can

after control variables more efficiently than human operation.


11/22

PASSIVE APPLICATION:

In this, computer does not control the interaction with an instrument,

but used for data handling, processing, file searching or display.

Data processing by computer may involve relatively simple mathematical

operation such as:

o Calculating of concentration, data storing.

o Sequence analysis, statistical analysis.

o More complex calculation may involve.

o Solving of non-linear equation.

o Performing Fourier transformation.(In, NMR, MASS Spectrometer).

o Determine of unknown concentration using calibration curve.


12/22

DATA STORAGE:

This function is very very useful especially in storing the results ofGLCMS Experiment.

The GLC separates components from the mixture and the mass

spectrometer identifies fragments of thee individual component basedon their mass.

GLC_MS may produce data for many spectra in a few minutes, each

spectrum being made up of few to hundreds of peaks & conversion of

these data into an interpretable form is often impossible.


13/22

Thus data are often stored in digital form for subsequent processing and

presentation in graphical form, this function is done by computer.

The HPLC-MS or HPLC-NMR data can also be handles in a similar way as

described for GLC-Ms various experiments in 2-DNMR are possible just

because of the use of computer because they involve complex calculation.


14/22

OTHER APPLICATIONS:

The connectivity through computer helps different department of institutes

to co-ordinate in a project.

Entering of goods received numbers like product name, source, batch

number and code numbers sampled by with date.

Taking of labels:

Under test.Passed.

Rejected.

Sample for analysis

Reserve sample.


15/22

To prepare test data sheet:

It should contain a test mentioned in a specification like description,

identification, LOD, LOQ, Assay, residual solves.

To preparing of specifications like good analytical methods ,sop, chemical

usage log, Working std usage log, instrumental usage log.

Connectivity through internet to a data base library helps in faster accession

of information from any part of the world.


16/22

SALVAGING OF RETURNED GOODS ANDREPROCESSING.

CONTENTS:

Definition

Advantage

Salvaging operation.

Reprocessing & Recoveries.


17/22

DEFINITION OF SALVAGING

Salvaging of returned goods may be defined as those goods which areto be disposed without causing to any harm to the living organism

Any rejection lying in the factory to obtained useful parts from them

are called salvaging of returned goods

ADVANTAGE:

It is the savings for advantageous use of disposal of

pharmacy companies property which is no longer economically

useful to its user in the present situation.

salvaging provides means of increasing cash income,

reducing the cost of the companies product or service and

conserving raw material.


18/22

SALVAGE OPERATION:

Proper collection of all material preferably at one place.

Storing them as systematically as other materials.

Storing in terms of quantity, size or specification so as to obtained maximum sale

value.

Reclamation of scrape material.

Restoring material to functional condition and transferring them to stores.

Selling the material immediately to buyer

Taking precaution for manufacturing waste products.

Procedure for salvaging of returned goods:

The finished goods which are sent to the market for sales may be returned back to

the stores


19/22

RETURNED GOODS:

The reason for the returned goods may include quality of the productpacking Problems, contamination of goods.

After receiving the returned goods to store, first we have to collect data

regarding date of receiving the goods, amount of the goods, types of

the goods, and due to which caution they are sent from the market.

We would also note about the stock exchange market of the product.

The returned goods are tested for quality control test once again and

compare with That of the standard limits.

If the goods have limited variations or if they can corrected.


20/22

If the returned goods are much variation when compared to the standard limits,They should be disposed in away that they are converted to harmless product

Which do not interfere the environment cycle.

Waste management legislation, Environment commities are formed on july2000.

This legislation made rules Reduce the waste.

These committees made rules and regulations to eliminate waste before it is

Produced reduce its quantity and toxicity.

Waste minimization can be used to reduce global waste problem.

The waste material is the biggest and major issue in the govt and community.

If we minimize waste by avoiding and reducing waste material we can control

up to 50 percent or more.


21/22

There are three problem which are invoved in the reduction of

waste material.

THEY ARE :Reduce

Reuse

Recycle.

REDUSE:waste should be reduced . The by -products or end products should be used in the

other manufacturing process and should be reduce the production of waste product

during manufacturing of the product.

REUSE:

The substances or the products which can be reused can be manufactured and reduce

the waste.


22/22

RECYCLE:

This process involves the converting the waste into useable products.

There are different types of material like GLASS, PLASTIC, ALUMINIUMwhich are used for packing the manufactured goods,

Eg; for glass- multi filling bottles and single filling bottles

REPROCESSING AND RECOVERIES

Where reprocessing is necessary, written procedures shell be established and

approved by the QA department that shell specify the conditions and limitation

of repeating chemical reactions, such reprocessing is validated.

If the product has to be processed the procedures shall be authorized and

recorded. An investigation shall be carried out into the causes necessitatingreprocessing and appropriate corrective measures shall be taken for prevention

of recurrence and then these are subjected to stability evaluation.

Recovery of product and control record by incorporating in subsequent batches

of the product.

Application of Computer in QC

Documents

Transcript of Application of Computer in QC