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Hafiz shoaib sarwar

PHARM-D

THE ISLAMIA UNIVERSITY OF BAHAWALPUR

INTERNSHIP REPORTGSK Lahore Factory

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OBJECTIVES OF INTERNSHIP

To get the insight of working as a professional pharmacist. To learn the working ethics in various fields of industry. To develop the basic skills regarding manufacturing and testing

drugs To improve the communication skills.

Brief History of GSK

In January 2001 Glaxo Wellcome plc and SmithKline Beecham plc

officially merged to become GlaxoSmithKline plc. GSKs history dates back

to 1715, when Plough Court pharmacy, a predecessor to SmithKline

Beecham, was opened in London.Glaxo Laboratories Limited (the predecessor to Glaxo Wellcome) was set

up in 1929, with director Alec Nathan. Nathan formed the company when

it was discovered that their dried baby food Glaxo was the cause of

rickets in children. The first product Glaxo Laboratories Ltd produced was

therefore Ostelin, a vitamin D concentrate to replace vitamins that were

destroyed in the food drying process.From the 1930s onwards there was

a flurry of mergers and acquisitions. The business of Glaxo Laboratories

Ltd expanded greatly with the new market created by the founding of the

National Health Service (NHS).And in 1972 Beecham Group Ltd made an

unsuccessful bid to buy Glaxo Group Ltd.

GSK facts

GSK dedicated to Research and Development for 80 years Cost of bringing a medicine to market: $800 million (Rs 4.8 billion) Average length of time to discover new drug: 10-15 years 5 out of every 10,000 compounds investigated reach clinical trial

phase and only 1 of those gets approved for patient use. GSK has industry's most extensive portfolio of R&D projects for

diseases affecting developing countries

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GSK Mission Statement

Our mission is to improve the quality of human life by enabling people todo more, feel better and live longer.

Documentation Management System

Documentation of all the procedures is being carried out effectively tokeep the record of every step involved in the purchase ,storage,manufacturing, testing of drugs . these documents are computer generatedand software used for this purpose are BPCS,LIMS and JD EDWARDS.By the use of these softwares each departments generate the documentsrelevant to them and the combination of all these documents is called adossier which provide the information of all the steps and activities being

carried out to complete a batch.

DOSSIER

Dossier is the documented record of a batch which provide the informationof all the steps and activities being carried out to complete a batch.

Dossier consists of followings

Manufacturing Documents

Analytical Documents Packaging Documents.

Manufacturing Documents

Shop packet manufacturing material

Batch manufacturing report(BMR)

Date of manufacturing certificate

Audit trial of R and I transaction

Fill weight record

Compression/filling record(for tablets and capsules)

Daily production/weight control sheet

Temperature and humidity record

In-process record sheet

Seal integrity and leak test record

Roller temperature record sheet

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Metal detector challenge record

Line clearance record

Analytical Documentation

Analytical test report for bulk(LIMS)

Analytical test report for filled(LIMS)

release pass label

Print outs of sample weights

Chromatograms of HPLC/UV spectrums

Pass label for approval of filling, coating or stripping

Packaging Documentation

Packaging material shop order Batch packing record(BPR)

R transaction

Cap seal check record

Fill weight check record sheet

In process packs/check record

Line clearance record

Overprinting record sheets with stereos

Bottle blowing record Fib rites weight record sheet

Empty bottle challenge record

Operational soft ware

These softwares are used to manage all the procedures going on in

factory.like purchasing transactions managing the inventory analytical

calculations. The documents generated by this softwares become the partof dossier as a batch record. There are three management softwares.

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These include.

LIMS (Laboratory Information and Management System)

BPCS (Business Planning and Control System)

JD-Edward

LIMSAn MS-EXCEL Based laboratory information management system (LIMS)

is a software-based laboratory and information management system that

offers a set of key features that support a modern laboratory's operations

and to meet the GSK core standards regarding the testing of drugs.

LIMS is connected between different sites of GSk to control various

analytical operations and calculations ..LIMS provide the following

advantages

Easy and rapid calculations of complex analytical functions .

People at different sites can communicate through LIMS .

Documents generated becomes the part of Dossier

Less chances of error .

BPCS

Business Planning and Control System is an Enterprise Resource

Planning (ERP) software used to control operations of the company like

finance, planning, manufacturing and distribution. Finance operation has

components like costing, accounts payable (ACP), accounts receivable

(ACR), billing and cash management etc. Planning function is associated

with manufacturing and distribution. Important BPCS uses regarding

distribution are inventory; purchasing and billing etc. and those regarding

manufacturing are manufacturing data management (BOM) and QMS etc .

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Financial Costing CST Accounts Payable ACP Accounts Receivable ACR Billing BIL Cash Management CSH Financial Assistant FIN Fixed Assets FXA Payroll PAY

Planning

Most planning functions can be used in either distribution or manufacturing.

Forecasting Master Scheduling MPS Material Requirements Planning MRP Capacity Planning CAP Distribution Resource Planning Just In Time JIT

Distribution.

Inventory

Purchasing Sales Analysis SAL Promotions and Deals PRO.

Manufacturing .

Manufacturing Data Management BOM Inventory Shop Floor Control Material Requirements Planning MRP

Repetitive Manufacturing Advanced Process (chemical) Industries API Performance Measurement (factory production) PRF

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PRODUCTS MANUFACTURED AT LHR FACTORYSuspensions:

Ceporex Suspension 125mg Ceporex Suspension 250mg Ceporex Suspension P. Drops 125mg

Capsules:

Ceporex Capsules 250mg Ceporex Capsules 500mg

Tablets:

Zinacef Tablets 125mg Zinacef Tablets 250mg

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EHS ORIENTATION

Environment

and Health Safety

First safe then operate

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EHS OrientationEHS stands for Environment & Health Safety.EHS is responsible for theprotection of environment and health of employees. It is necessary thatFIRST SAFE THEN OPERATE.

GSK has a sound environment, health and safety (E.H.S) policy and

department.

This department ensures that the activities at the site have minimum

hazards on our environment and also ensure the safety and of the

employs.

The engineering department ensures the maintenance of plant, its

machinery, health of employees. Like

Environmental engineers

Mechanical engineers

Doctors

Fire fighters

The EHS orientation includes

Assembly Points:

Every building is allotted an assembly point, when unfortunately there isfire then each member is advised to leave that area and enter into their

respective assembly point so that counting of people which have entered

into that building before fire and people standing in assembly point after

fire became easy.

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Assembly line:Assembly lines are fire exits in every building so that during fire movingout from building became easy.

Fire Zones:There are total 13 fire zones and each department has its own fire zone.

Smoke Detectors & Fire Alarms:Each building has its own fire alarms and each room contains its ownsmoke detector to detect minute quantity of smoke generated .

Medical centerBrief description about medical center to approach in case of any medical

emergency.

EHS incident Report Panel:

This panel is located at different locations. The purpose of this panel is to

inform about major or minor damage with equipment or with employees

himself and its remedial action is taken when suggested. When there is

unwanted incident then all the employees are advised to report that

incident in the form provided in that panel.

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QUALITY CONTROL

Analytical Laboratory

Quality is the heart of all activities that support

the discovery, supply and marketing of products

to our patients and customer. Quality is critical to

building trust with society and therefore our future

business success. (GSK Quality Statement)

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Quality control department is responsible to maintain the quality of

products .for this purpose GSK has established a well equipped analytical

lab to cary out the testing of products. for the testing of drugs GSK has its

own standards called GSK Core Standards and according to these

standards SOPs are developed which consist of IFS and TEST Methods.

Testing being carried out in analytical lab is

Raw material testing

Bulk testing

Finished product testing

Stability testing.

Raw Material Testing.

Testing of raw materials is carried out to ensure the compliance of

materials according to the standards laid down by the GSK for the relevant

material. This is to ensure the quality at very early stage of manufacturing

to produced quality products.

BULK TESTING.

Bulk testing is carried on products after their manufacturing but before thefinal packaging. this to ensure the compliance of products to the standards

and to resolve any problem, if any, before the final packing.

Finished Product Testing.

Testing carried on the final and finished form of products so as to ensure

the quality of product is maintained during packing and filling operations

and to resolve the problem, if any , before the distribution of products into

market.

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Stability Testing .

Stability is carried on to check the environmental effects on the stability of

products e.g. the effects of temperature and humidity. Samples are kept at

various temperature and humidity range for specific period of time and

stability testing of these samples are carried on according to a specific

schedules.

following tests are carried on

TESTS FOR TABLETS

Uniformity of Weight

Uniformity of Mass

Friability Tablet Coat Rupture Time

Dissolution Test

Disintegration Time

TESTS FOR CAPSULES

Appearance

Identity

Disintegration Time Assay by UV or HPLC

Uniformity of mass

In process tests of capsules include

Description

Filled weight

TESTS FOR SUSPENSIONS

Appearance

Identity

Water by Karl Fischer

pH

Uniformity of Content

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Microbial Limit Test

Deliverable Volume and Dissolution Time

In process tests of suspensions

Humidity

Temperature

Seal Integrity Test

Fill Weight of Bottle

Distilled water

Appearance pH

Hardness

Non-volatile metal

Chlorides

Sulphate

Nitrate

Ammonium

Heavy metal

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INSTRUMENTS AVAILABLE.

UV Spectrophotometer

Model :UV 1800

Software: UV Probe 3.2

Company: shimadzu

Designed in accordance with the governing European and Japanese

Pharmacopoeia, the new UV-1800 UV-VIS spectrophotometer achieves a

resolution of 1 nm, the highest in its class, in a compact design. Offering

an array of user-friendly features, the UV-1800 can be used as either a

stand-alone or as a PC-controlled instrument.

Modes :

Photometric mode

Measures the absorbance or transmittance at a single wavelength or at

multiple (up to eight)

Spectrum Mode

Obtains sample spectra using wavelength scanning.

Kinetics Mode

Measures the change in absorbance as a function of time, and thereby

obtains enzymatic activity values.

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KARL FISHER TITRATOR

Model : DL31

Company : Mettler Toledo

karl Fischer Titrator is widely used instrument

for determining of micro amount of water in variety

of products,invented by a German chemist Karl Fischer in 1930 .

In this reaction, the alcohol reacts with sulfur dioxide and base to form an

intermediate alkyl sulfite salt, which is then oxidized by iodine to an alkyl

sulfate salt. This oxidization reaction consumes water.

KF Reagents:The KF reagents includes

Imadazole

Iodine

Sulfur dioxide

Methanol

Function of Imadazole:Imadazole is used as basic reagent and it ligand it and can complex the

iodine and sulfur dioxide hence lower the vapor pressure of both iodine

and sulfur dioxide.

Function of Methanol:During titration sulfur dioxide can react with water so to control this side

chain reaction excessive amount of methanol is added to lower the

concentration of sulfur trioxide hence stops such unwanted reactions.

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Procedure:Firstly weight the sample like for example ceporex bulk testing we use 0.5

grams granules and print that weight and add in the flask gave sample

weight in instrument and analysis began then after few minutes it print

yours result.For TabletsGround 1 tablet in pastor and motor and take that tablet in the flask of

instrument then cover the flask with its cap and run sample analysis and

after few minutes it print your results.

PH Meter

Model :HI 9020 microprocessorCompany: HANNA

HPLC ( High Pressure Liquid Chromatography)

High-performanceliquid

chromatography(sometimesreferred to as high-pressure liquid

chromatography), HPLC, is a

chromatographic technique that

can separate a mixture of

compounds and is used in

http://en.wikipedia.org/wiki/Chromatographichttp://en.wikipedia.org/wiki/Chromatographic

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biochemistry and analytical chemistry to identify, quantify and purify the

individual components of the mixture.

TOC Analyzer

Total organic carbon (TOC) is the amount of carbon bound in an organiccompound and is often used as a non-specific indicator of water quality orcleanliness of pharmaceutical manufacturing equipment.

A typical analysis for TOC measures both the total carbon present as wellas the so called "inorganic carbon" (IC), the latter representing the contentof dissolved carbon dioxide and carbonic acid salts. Subtracting the

inorganic carbon from the total carbon yields TOC. Another commonvariant of TOC analysis involves removing the IC portion first and thenmeasuring the leftover carbon. This method involves purging an acidifiedsample with carbon-free air or nitrogen prior to measurement, and so ismore accurately called non-purgeable organic carbon (NPOC

To understand the analysis process better, some key basic terminologiesshould be understood and theirrelationships to one another(Figure 1).

Total Carbon (TC) all thecarbon in the sample,including both inorganicand organic carbon

Total Inorganic Carbon(TIC) often referred to asinorganic carbon (IC),carbonate, bicarbonate,and dissolved carbon

dioxide (CO2). Total Organic Carbon (TOC) material derived from decaying

vegetation, bacterial growth, and metabolic activities of living organismsor chemicals.

Non-Purgeable Organic Carbon (NPOC) commonly referred to asTOC; organic carbon remaining in an acidified sample after purging thesample with gas.

http://en.wikipedia.org/wiki/Biochemistryhttp://en.wikipedia.org/wiki/Analytical_chemistryhttp://en.wikipedia.org/wiki/Carbonhttp://en.wikipedia.org/wiki/Organic_compoundhttp://en.wikipedia.org/wiki/Organic_compoundhttp://en.wikipedia.org/wiki/Water_qualityhttp://en.wikipedia.org/wiki/Acidhttp://en.wikipedia.org/wiki/Nitrogenhttp://en.wikipedia.org/wiki/Carbonatehttp://en.wikipedia.org/wiki/Bicarbonatehttp://en.wikipedia.org/wiki/Solvationhttp://en.wikipedia.org/wiki/Carbon_dioxidehttp://en.wikipedia.org/wiki/Carbon_dioxidehttp://en.wikipedia.org/wiki/Metabolismhttp://en.wikipedia.org/wiki/Metabolismhttp://en.wikipedia.org/wiki/Carbon_dioxidehttp://en.wikipedia.org/wiki/Carbon_dioxidehttp://en.wikipedia.org/wiki/Solvationhttp://en.wikipedia.org/wiki/Bicarbonatehttp://en.wikipedia.org/wiki/Carbonatehttp://en.wikipedia.org/wiki/Nitrogenhttp://en.wikipedia.org/wiki/Acidhttp://en.wikipedia.org/wiki/Water_qualityhttp://en.wikipedia.org/wiki/Organic_compoundhttp://en.wikipedia.org/wiki/Organic_compoundhttp://en.wikipedia.org/wiki/Carbonhttp://en.wikipedia.org/wiki/Analytical_chemistryhttp://en.wikipedia.org/wiki/Biochemistry

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Dissolved Organic Carbon (DOC) organic carbon remaining in asample after filtering the sample, typically using a 0.45 micrometer filter.

Suspended Organic Carbon also called particulate organic carbon(POC); the carbon in particulate form that is too large to pass through afilter.

Dissolution Tester

Type of apparatus in use

USP Dissolution Apparatus 1 - Basket (37C) USP Dissolution Apparatus 2 - Paddle (37C)

In the pharmaceutical industry, drug dissolution testing is routinely used toprovide critical in vitro drug release information for both quality controlpurposes, i.e., to assess batch-to-batch consistency of solid oral dosage

forms such as tablets, and drug development, i.e., to predict in vivo drugrelease profiles

http://en.wikipedia.org/wiki/Micrometrehttp://en.wikipedia.org/wiki/Particulatehttp://en.wikipedia.org/wiki/In_vitrohttp://en.wikipedia.org/wiki/Quality_controlhttp://en.wikipedia.org/wiki/In_vivohttp://en.wikipedia.org/wiki/In_vivohttp://en.wikipedia.org/wiki/Quality_controlhttp://en.wikipedia.org/wiki/In_vitrohttp://en.wikipedia.org/wiki/Particulatehttp://en.wikipedia.org/wiki/Micrometre

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Weighing balance

Models: AE 160, AE163,PM4600

Company : Mettler Toledo

VISCOMETER

For the measurement of viscosity

GAS Chromatograph

For the determination of impurities in a given sample

Tintometer

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