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SYNOPSIS ON

Quality Control Practices in Pharmaceutical Industry:A Case Study of units Located in Haryana

QUALITY ASSURANCE IN

PHARMACEUTICAL INDUSTRIES -A CASE

STUDY OF HARYANA UNITS


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I) INTRODUCTION TO TOPIC

II) TQM IN INDIAN PHARMACEUTICAL INDUSTRY

III) Indian pharmaceutical industry is fourth largest industry in its

field by volume in the world. Industry is known for providing

quality products at lower price through out the globe. Most of the

companies who were acting as domestic player now trying to

expand their business in abroad. Due to globalization trade

barriers are removed day by day to facilitate the global trade.

Most of the pharmaceutical companies are trying to tap the

emerging markets in European Union and USA due to high

profitability and more paying capacity of the customer. To cope

with other competitor from abroad Indian companies can use

TQM as a weapon. Companies have understood the importance

of TQM that is why most of the companies are trying to get ISOcertification and USFDA approvals. India has the maxim number

of US DA approved Plants after Italy.

Good Manufacturing Practices (GMP):

GMP is that part of Quality assurance which ensures that products are consistently

produced and collected to the quality standards appropriate to their intended use and

as required by the marketing authorization or product specifications .GMP is

concerned with both production and quality control.

Current Good Manufacturing Practices (cGMP):

They are promulgated by the commissioner of federal Food and

Administration (FDA) , which specifies that the drug is deemed to be adulterated

if the methods used in , controls used for, its manufacture, processing ,


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packaging or holding do not conform to or are not administered in conformity

with Current Good Manufacturing Practices. The manufacture of pharmaceuticals

must be by current methods with current control as a requirement that which is

current or generally, accepted in drug industry as appropriate equipm

methodology controls and records. The standard is not only that practices be

current .but that they also be good. Thus if a new practice is introduced

anywhere in the industry which is better than what is current , then all

manufacturers may seem obligated to adopt the better practices. Therefore it can

be seen that being in compliance with the GMP is not a static situation, but

requires the manufacturer to be aware of innovations which may be good. Even if

current practices were available, the FDA holds that it has special technical &

scientific experience to determine which of the current practices are also good.

A current, although not necessarily predominant, practice is considered good if:

1) It is feasible for manufacturer to implement.

2) It considers to ensuring or added assuring the safety, quality or purity of the drug

product.

3) The value of the contribution or added assurance exceeds the cost in money of

implementing or continuing the practice.

Quality Assurance (QA):

QA is wide ranging concept which covers all matters which individually or

collectively influence the quality of the product. It is the sum total organized

arrangements made with the object of ensuring that medicinal products are of quality

required for their intended use. QA is related to all operations in

manufacturing, testing & records.

Quality control (QC):

QC is a part of GMP which is concerned with sampling, specifications and testing

and with the organizations, documentation and release procedures which ensures that

the necessary tests are actually carried out and that materials are not released for use,


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nor products released for sale or supply, until their quality has been judged to be

satisfactory.

In Process Quality Controls:

These are the checks performed during production in order to monitor & if necessary

to adjust the process to ensure that the product conforms to its specifications.

Environmentalcontrol & equipment controls are also considered as in process

control. Temperature, Humidity, Microbial count of area may be considered as

IPQC/IPC.

Certification for the pharmaceutical industries

Following are the certificates, which are applicable for pharmaceuticals

regulatory or commercial purposes.

1. Indian GMP (Schedule M) Statutory from June 1988 in India.

2. International Organisation for standards (ISO 9001 & 14001)

3. World Health Organisation (WHO GMP)

4. Therapeutic Goods Administration (TGA), Australia

5. Medicines Control Council (MCC), South Africa

6. cGMP Certification from US Food and Drug Administration

7. Medicines and healthcare products regulatory authority agency (MHRA), U.K

8. International Conference on Harmonization (ICH) USA, Europe & Japan

9. Certificate of Suitability (COS) Europe


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From early 20th century there has been a rapid increase in the rate of introduction of

pharmaceutical industries. Pharmaceutical is derived from Pharmacology. Pharmacologyis a branch of science about medicinal substances called pharmaceuticals. The field

encompasses drug composition, drug properties, interactions, toxicology and desirable

effects that can be used in therapy of diseases.

Pharmaceutical is referred to as formation of medicine or medicament for use in the

diagnosis, cure, mitigation, treatment or prevention of disease.Pharmaceutical industrycomprises establishments primarily engaged in one or more of the following:

(1) Manufacturing biological and medicinal products.

(2) Processing (i.e., grading, grinding and milling) botanical drugs and herbs.

(3) Isolating active medicinal principals from botanical drugs and herbs.

(4) Manufacturing pharmaceutical products intended for internal and extern

consumption in such forms as tablets, capsules, vials, ointments, powders, solutions and

suspensions.


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India is the forth largest manufacturer of pharmaceuticals in the global market. It clearly

depicts that the prices of medicines in India are lowest in the world. India is paying for

quality health care. India is the growth driver for global drug companies. Indian

pharmaceuticals industry has over 20,000 units. Around 246 pharmacy industrie

constitute the organized sector of pharmaceuticals in Haryana, while others exist in the

small scale sector. There has been a rapid increase in the rate of introduction of new and

potent medicines. The assessment of quality of the medicines rests with

manufacturers. Quality remains a main issue with the assurance of product to adhere

quality. A system of quality control performed at a manufacturing site is known as

Quality Assurance. It isthe sum total of the organized arrangements made to ensure that

all APIs (Active Pharmaceutical Ingredients) are of the quality required for their intended

use and that quality systems are maintained. In the face of a challenging regulatory

environment pharmaceutical companies have found ways to improve quality and costs

significantly. To drive benefits from change, companies had created a culture where

quality objectives are transparent, well understood and goals can be achieved by

following certain sets of procedures called as Standard Operating Procedures

(SOP). A Standard Operating Procedure (SOP) governed by World Health Organization

is a set of written instructions that document a routine or repetitive activity which is

followed by employees in an organization. A Pharmaceutical Industry has an average of

1200- 1300 SOPs and these SOPs are governed by ISO: 9000 series. There are many

leading pharmaceutical industries which adopts SOPs such as: Sun pharmaceuticals,

Torrent pharmaceuticals, pfizer India, Novartis India, glaxoSmithKline, AstrZeneca etc.

In a nut shell it can be said that Quality Assurance has undoubtedly evolve in

pharmaceutical industries stating quality from manufacturing processes, process control,

material, staff and training, organization of department to quality manuals.

IV) SIGNIFICANCE OF THE STUDY

This study will be conducted basically to provide a new perspective to research world.

The main idea to select this topic is to have in depth knowledge in the field of Quality

Management. The study will provide knowledge how pharmaceutical companies keep

health care dimensions important by maintaining quality. This research work will


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facilitate the knowledge for dimensions of quality in technical, personnel and material

terms. Pharmaceutical is the emerging field in the health care services therefore this study

is proposed to be done to touch in depth pillars of pharmacy.

TOPIC: Quality Control Practices in Pharmaceutical Industry:A Case

Study of units Located in Haryana

QUALITY ASSURANCE IN PHARMACEUTICAL INDUSTRIES-A

CASE STUDY OF HARYANA UNITS

V) EXPLANATION OF THE TERMS USED

Quality:

i) It is the totality of features and characteristics of a product or service that bear

on its ability to satisfy a given need.

ii) Quality means the degree to which a specific product satisfies a particular

class of consumers in general or the degree to which it conforms to a design

specification or the distinguishing feature of a products taste, co

appearance etc.

Definition:

An asset which may be offered to the potential customer of a product or service.-

C.D.Lewis

Quality Assurance

i) It is quality control with an emphasis on quality in the design of the

products, processes and jobs in the selection of personnel and their

training.ii) It is the system of setting the quality standards, apprai

conformance to the standards, actions taken when standards are not

met and planning changes in these standards.

Definition


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All actions taken to ensure that standards and procedures are adhered to and that

delivered products or services meet performance requirements is Quality Assurance.

PHARMACEUTICAL INDUSTRIES

i) Public and private organizations involved in the manufacture of drugs and

medications.

IV. OBJECTIVES OF THE STUDY

(i) To identify & analyze the different elements of a TQM system

pharmaceutical entity.

(ii) To study the impact of Quality Certification, Annual Turnover and Investment inthe Manufacturing Plant on each Quality Factor.

(iii) To determine the correlation between the Quality Certification, Annual

Turnover & Investment in the Manufacturing Plant.

VI. REVIEW OF LITERATURE

Proactive pharmacovigilance should be mandatory for pharmaceutical industrie

suggested by Pipasha Biswas (2007)An increase in drug safety concerns in recent years

with some high profile drug have led to raising the bar by various stakeholders more

importantly by the regulatory authorities. The number of Adverse Drug Reaction (ADRs)

reported have also resulted in a an increase in the volume of data handled and to

understand pharmacovigilance a high level of expertise is required to rapidly detect drug

risks as well to defend the product against an inappropriate removal. Pr

pharmacovigilance throuought the product life cycle is the way forward and the future

direction for drug safety. It is a challenge to codify and standardize the act of signal

detection and risk management in the context of clinical trials and post-marketing

pharmacovigilance. While major advancements of the discipline of Pharma have taken

place in west , not much have been achieved in India, there is an immense need to

understand pharmacovigilance .for this to happen in India, the mind of people working in

regulatory agency (DCGI office) and Indian Pharmaceutical companies need to change.


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various strategies are adopted for successful quality check: 1) making pharmacovigilance

mandatory and introducing pharmacovigilance inspections 2) list all drugs/ indications by

maintaining a standard database for every pharmaceutical company 3) Interaction with IT

sector in building a robust pharmacovigilance system for India.

Kishore Gnana Sam (2008) explained that readymade and informative knowledge in the

form ofStandard Operating Procedures (SOPs) enhances the clinical management.

Implementing quality requires collaboration across disciplinary, functional units. Hence a

survey was carried out among thirty pharmaceutical companies to assess the need of

Standard Operating Procedures which act as a supportive management guidelines. The

lab in charge accepted that guidelines can reduce inappropriate variations and support

quality and safety initiatives. Using guidelines document as a knowledge source promote

authentic translation of domain knowledge. With these SOPs better tools are created to

facilitate the process. Majority of lab incharges supported that clinical practice guidelines

should be collaborated with laboratories so as to create collaboration among the units.

D.H.Shah(2007), has explained in his book SOPs and explained that for centuries quality

has remained a complex problem. World Health Organization (WHO) SOPs as a global

initiative for controlling variability. As per the protocol published by WHO analysis of

each SOP is necessary. This method provides rapid assessment of the quality of the

products for mass distribution and currently recommended/ adopted statutory methods. A

decision tree stating the procedure of laboratory for quality assurance and control have

the following salient features: 1) efficient identification of good quality formulations ii)

assure batch-to-batch consistency with respect to quality and performance iii) facilitate

the reduction of development time and simplify the processes.

Dr. Aniruddha (2009) has reported that by encouraging pharmaceutical companies to

put their clinics and doctors online, the Indian Health Ministry can help the Indian

pharmacy Industry to export their specialized medical devices, medicines and knowledge.

A website has become an integral part of modern medical practice. Website benefits are

not restricted to practice promotion only but also to make sales online through online

clinics. For example: doctors sell ovulation test kits and self insemination kits on the


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companies website, allowing infertile couples in India to buy fertility tools. This is an

additional revenue stream.

While describing the status of Pharmaceutical companies in India Subodh Priolkar

(2009) analyzed that the global pharmaceutical market was around USD 735 bn in 2008.

China contributes around 2% and Indias contribution is a meagre1.8%. With such an

insignificant contribution not amounting to even double digits pressure on Indian

pharmaceutical companies has increased. There is a drastic reduction in drug approval

from USFDA. In 2007, there were only 19 approvals; the lowest in last 24 years.

Increased market of generics has lead to slow growth of pharmaceuticals. All of these

have led to tremendous escalation in the new drug development costs. galxoSmithKline

has already closed 28 plants since 2000. Novartis has reduced approximately 25, 00 jobs.

Pfizer close its in-house production and start outsourcing to china. The dream of making

India a hub of pharmaceutical requires overhauling of Indian pharma quality control

system.

A study done by Anuja. R. Shah (2008) has revealed the fact that on October 6, 2005,

the Government of India released the Gazette indicating sterile devices as drugs for

internal and external use in the diagnosis, treatment or research in human beings and

animals. In light of escalating use of medical devices, stringent regulatory standards are

made to ensure that the devices are safe, well studied and have least adverse reactions.

Drug and cosmetic act have boosted the global confidence in pharmaceutical industry in

India; pharmacy personnel can certainly play an important role in the regulation of medial

devices. Safety, risks, effectiveness and performance of the medical devices need to be

well established and regulated properly. According to WHO medical devices include

everything from highly sophisticated computerized medical equipment to simple wooden

cutter. Medical devices include medical gloves, bandages, syringes, disinfectant, surgical

lasers, machine appliances, software or other similar or related articles. The clinical

effectiveness of the devices used should be revised on parameters. Documentary of

standard devices containing technical specifications are to be recorded to ensure that

material, product, process and services are fit for their purpose and management

specifications meet their standards.


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Dr. Prashant Gargava (2009) an environmental engineer in central Pollution Control

Board (CPCB) explained thatQA integrates quality control, quality auditing,

measurement method validation, and sample validation in to the measurement process.

QC is intended to prevent, identify, correct, and define the consequence of difficulties,

which might affect the precision and accuracy, and or validity of the measurements. The

QC activities include: (1) modifying standard operating procedures (SOPs) to be followed

during sampling, chemical analysis & data processing by the respective organization; (2)

equipment overhaul, repair, acceptance testing & spare parts; (3) operator training,

supervision & support; (4) periodic calibrations and performance tests which include

blank (including field blanks) & replicate analysis; and (5) quality auditing. Quality

control activities begin with the design of the sampling and measurement strategy and

continue through the final validation of the database. Quality control has in fact been

identified as responsibility of the laboratory conducting the work. These activities

include:

The development of standard operating procedures with comprehensiv

measurement performance checks to ensure the quality of the measurements are

within established tolerance levels;

Proper training and certification of operators/analysts to ensure data quality; The inclusion of measurements for the estimation of accuracy, precision, and

detection limits to crosscheck analytical performance needed to ensure data

quality;

Verification of comparability with related measurements between

operators/analysts;

Documentation of field and analytical activities; and

Data validation

VII. RESEARCH METHDOLOGY

Contents of the Questionnaire:


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The final questionnaire will include almost every aspects of Total Quality Management

relevant to a Pharmaceutical Manufacturing Plant.

The areas covered:

Vendors control

Control of Purchased Material

Process Identification & Verification

In Process Control & Measurement Assurance

Maintenance of Production & Auxiliary Facilities

Post Production Functions- Handling, Storage, Packaging, Preservation &

Delivery

Quality Documentation; Records & Audits

Commitment & Leadership for Quality

Use of statistical tools & other tools for TQM

A) Data collection method

The plank on which the study rests is information, which will be procured of with a

judicious mix of both secondary data and primary sources of data.

1. Primary Data

Data which shall be collected specifically for this research includes: -

i) Interview and survey of pharmaceutical company personnel which will cover labmangers, lab technicians and scientists through a closed questionnaire with

informed ideas about the subject of the research.

ii) Observation, recognizing and recording relevant events and activities.

iii) One-to-one interview with employees.

iv) Group interviews.


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v) Observation.

2. Secondary data

i) Books

ii) Periodicals (magazines, journals)

iii) The World Wide Web for Information or the Internet

B) Sample Design

1. Sampling Element: The basic elements which shall be studied are Plant Managers not

lab mangers, lab technicians and scientists of organized and small scale pharmaceutical

companies.

2. Population: A sample size of pharmaceutical industries of Haryana will be surveyed.

3. Sampling Methodology:The probability-based approach of stratified random

sampling will be adopted, in order to give adequate coverage to the selected area.

4. Sample Size: A sample size of 10 companies will be obtained. It should be at least 30

to 35% of the population.

D) Tools Used:

A questionnaire will be formulated to collect data for the purpose to know the level of

Quality Assurance in organized and unorganized pharmaceutical companies. For the

purpose of analysis and interpretation of the data bar charts and table formats will be used

to concise the data. To calculate and analyze the results chi-square and percentagemethod shall be applied.

E) Statistics Used:

The collected data will be analyzed through following statistical tools:

(i) Frequency diagrams to analyze each attribute of TQM.


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(ii) Analysis of variance (ANOVA) between samples & within samples & carrying

out F-test at 5% level of significance for data collected across pharmaceutical

companies on each TQM attribute.

(iii) Chi-Square test to determine the correlation between attributes on

Nominal scale.

BIBLIOGRAPHY

Journals

1) Anuja.R. Shah & R.K.Goyal (2008), Current Status of the Regulations of

Medical Devices, Indian journal ofPharmaceutical Sciences Vol.14, pp.695-

700.

2) Kishore Gnana Sam(2008), Physician Need Assessment for Supportive Medical

Management Guidelines for Positioning in a Territory Care South Indian Hospital

IndianJournal of Hospital Pharmacy, Vol.7, pp.104-109.


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3) Pipasha Biswas & Arun K.Biswas (2007), Setting Standards for Proactive

Pharmacovigilance in India: The Way Forward ,Indian Journal of

Pharmacology, Vol.39, Issue:3, pp.124-128.

4) R.D.Garg & Nupur Kaul (2008) Growth of Pharmacy in Delhi, Indian Journal

of Hospital Pharmacy, Vol.7 (2008), pp.119-120.

5) Subodh priolkar (2009), Can India be Pharmaceutical Superpower in 2020?

Pharma Times, Vol.41, No.1, pp.9-14.

6) Y.Ashokraj & Shrutidevi Aggarwal (2008) A Decision Tree for Rapid Quality

Assurance, Indian Journal of Pharmaceutical Sciences Vol.14, pp.1-5.

Magazines

1) Dr Aniruddha (2009), Online Doctors, Modern Medicare Magazine pp.52.

2) Ramesh Subrahmanian (2009), Cover Story: Pharmaceuticals, Business World,

Vol.29, pp.32-36.

Books

1) D.H.Shah (2007), Introduction to Quality Assurance, QA Manual, Business

Horizons, New Delhi, ISBN: 8190078828,pp.1-5,

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