Total quality management (TQM), and current Good Manufacturing Practice (cGMP) for pharmacy students

Dr. P. Ravisankar M. pharm., Ph.D.Professor and HODDepartment of PAQAVignan pharmacy college,Vadlamudi

B. Sindhura

Total Quality Management (TQM) and current Good Manufacturing Practice (cGMP)

For Pharmacy students(B. Pharm, M.Pharm and

Pharm D)

Vignan Pharmacy College, Vadlamudi.

2

Introduction

To the better understanding the meaning of the total quality

management we should firstly understand the meaning of the

“Quality”.

“Quality is customer satisfaction” ,“Quality is Fitness for Use.”

Loss of quality means loss of customer satisfaction , public health

and loss of organization resource.


3

Definition

Total quality management (TQM) is a modern approach to the

management of the whole organization that emphasizes the role

of quality in meeting the needs and expectations of its customers.

TQM stresses the need for the whole company to manage quality

at every stage of production and interaction with the customer


4

TQM can also be defined as

1. Total : Every employ of the organization is involved.

2. Quality : Customer requirements are continuously satisfied.

The quality here focuses in 3 perspectives:

Quality of the products and services aligned with customer

specifications

Quality or amount of returns to satisfy the stakeholder needs

Quality of working conditions internal to the organization.


5

TQM can also be defined as

3. Management : Senior management is fully committed toward the

goals of total quality (customer satisfaction, effective employee

participation, doing things right first time, eliminating the wastes

and defects, increasing the efficiency and effectiveness of the work)

TQM ensures that the management adopts a strategic overview

of the quality & focuses on prevention rather than inspection.


6

Importance

Quality culture means prevention and elimination of errors,

waste, reworks. So, the concept of TQM has been developed

from inspection of quality control and quality assurence.

TQM is extremely important to business because it keeps a

company competitive and productive.

It not only focuses on quality but also on the continuous

improvement of process capabilities.


7

TQM framework

It covers all aspects of an organization

and the way it operates.

Performance is achieved by planning

the involvement of people in improving

the processes.

All this can be implemented by an

effective leadership, communication

and commitment.

Excellent performance of TQM

https://wzekry.wordpress.com/2013/01/10/total-quality-management-part-1/tqm-framework/


8

Key concepts

TQM

Systematic approach

Integrated system

Continuous improvement

Effective communication

trainingProcess thinking

Customer satisfaction

Total employee commitment

Team work and quality

chain


9

Key Principles of TQM

There are number of key principles that can be identified and

associated with the definition of the TQM, including:

TQM principle

s

Quality

oriented

management

Satisfy the

customer

Satisfy the

supplier

Continuous improvemen

t



10

Quality oriented management

Management should inspire and motivate the entire workforce

Communication strategy, method and timeliness must be well

defined to be followed by the entire workforce.

The mission and vision should balance the needs of the company

and customers.

Top management should act as the main driver for TQM and create an environment that ensures its success.



11

Satisfy the customer

Satisfaction is basically physiological state,

Satisfaction is a function of total experience with organization.

The research gives ten domains of satisfaction includes:

Quality, value, timeliness, efficiency, ease of access,

environment, inter-departmental team work, commitment to the

customer and innovation.



12

Satisfy the supplier

External suppliers: A company must look to satisfy their

external suppliers by providing them with clear instructions and

requirements and then paying them fairly on time.

Internal suppliers: A supervisor must try to keep his or her

workers happy and productive by providing good task

instructions, the tools they need to do their job and good working

conditions. The supervisor must also reward the workers with

praise and good pay.



13


It’s a never-ending improvement.

Continuous improvement, called kaizen by the Japanese,

requires that the company continually strive to be better through

learning and problem solving. Now let’s look at two approaches that can help companies with

continuous improvement: the plan–do–study–act (PDSA) cycle

and benchmarking.



14


The Plan–Do–Study–Act Cycle The plan–do–study–act (PDSA)

cycle describes the activities a company needs to perform in

order to incorporate continuous improvement in its operation.

Continuous

improvement



15

Specific steps in the cycle

1. PLAN:

Managers must evaluate the current process and make plans based

on any problems they find

They need to document all current procedures, collect data, and

identify problems.

2. DO (implementing the plan) :

During the implementation process managers should document all

changes made and collect data for evaluation.



16

Steps in the cycle

3. STUDY:

The data are evaluated to see whether the plan is achieving the goals

established in the plan phase.

4. ACT:

The best way is to communicate the results to other members in the

company and then implement the new procedure if it has been

successful.

Note that this is a cycle; the next step is to plan again, we need to

continue evaluating the process, planning, and repeating the cycle again.



17

Stone work of TQM

will focus on explaining the main steps (stages) that help in paving the way for the organizational transition to TQM…

https://wzekry.wordpress.com/2013/01/20/total-quality-management-part-3/paving-the-way-for-organizational-transition-to-tqm/


18

Benefits of TQM

Customer’s confidence.

Improvement of organization's reputations.

Increase in productivity.

Reduction in product cost.

Increase in profits.

Employ motivation.

Team spirit.

Improvement in attitude.


Vignan Pharmacy College, Vadlamudi. 19


20

Current good manufacturing practice

What is good manufacturing practice (GMP) ?.........

GMP is a part of quality assurence, which ensure that product

are consistently produced and controlled to the quality standards.

Every product should be manufactured pure, safe, effective…

FDA is also having this responsibility and one of the FDI work

and inspect, food , drug manufactured by the factories and other

health care organizations.

These controls & practices established in government regulations

called GMP.



21

Principles of GMP

1. Writing step by step operating procedures and work instructions.

2. Following written procedures and instructions.

3. Properly and accurately documenting our work.

4. Validating our work.

5. Designing & constructing facilities and equipment

6. Maintaining facilities and equipment.



22

Principles of GMP

7. Clearly defining, developing and demonstrating job competence.

8. Protecting our products against contamination.

9. Building the quality in to the product by system quality

controlling components and product related process. Such as

manufacturing, packing, labeling, testing, distribution, marketing.

10. Conducting planed and periodic audits.



23

why are GMP’s requirement?

Government requirement.

Ensure quality products.

Reduced rejects and recalls.

Satisfied customers.

Maintain manufacturing consistency.

Company image and reputation.



24

Importance of GMP

In the United States the Center for Drug Evaluation and Research

(CDER) promotes and protects public health by assuring that safe

and effective drugs.

There exits different types of risk with medicines..

one of which is a preventable adverse event, which can be

caused by different reasons.

One of the reasons for this event can be a product quality defect.

This risk can be avoided by effective implementation of GMP.



25

why good manufacturing practices (GMPs) established?...

GMP regulations were originally established over time after three

tragedies. They are as follows:

1. Elixir sulfanilamide disaster.

2. Sulfathiazole calamity. 3. Thalidomide disaster.



26

Elixir sulfanilamide disaster

In mid 1937 S.E Massengill company, a pharmaceutical

manufacturer has been selling, treatment for streptococcal

infections in tablets and powder form.

So, in 1937 the company’s chief pharmacist and chemist created the

liquid form by dissolving in the active ingredient.

By Diethylene glycol (CH2OH)2O as a solvent a new product was

formed. The preparation is called as “elixir sulfanilamide” by the

addition of raspberry as a flavoring agent



The company chemist who designed the cough syrup by mixing a

sulfa drug into the poisonous sweetener.

FDA scientists would quickly realize, the syrup was toxic because

it was sweetened by a compound known as DEG which kills by

causing acute kidney damage.

The first case of a death from ethylene glycol occurred in 1930

and studies had been published in medical journals stating DEG

could cause kidney damage or failure.

Although animal testing should have been routine in most drug

company operations, Massengill performed none .

https://en.wikipedia.org/wiki/Animal_testing


As FDA scientists would quickly realize, the syrup was lethal

because it was sweetened by a compound known as

diethylene glycol.

The company started selling and distributing the medication in

September 1937. By October 11, the

American Medical Association received a report of several deaths

caused by the medication.

Watkins, the chemist, committed suicide while awaiting trial.

Congress responded to public outrage by passing the 1938 Food,

Drug, and Cosmetic Act, which required companies to perform

animal safety tests on their proposed new drugs.

http://www.ncbi.nlm.nih.gov/pubmed/737988

https://en.wikipedia.org/wiki/American_Medical_Association


29

Sulfathiazole calamity

In 1940, a cross-contamination from equipment sharing resulted in

Winthrop chemical producing contaminated sulfathiazole tablets

contaminated with sedative phenobarbital.

An investigation by US Food and Drug Administration and the

findings resulted in actions. Therefore the agencies retrieve the drug

remaining on the market.

The incident was powerful in the introduction of GMP for drugs.

This results in more than 300 deaths and injuries.

https://en.wikipedia.org/wiki/Food_and_Drug_Administration



Thalidomide disaster 30

Thalidomide was first developed by a German pharmaceutical

company called Grunenthal in Stolberg.

Thalidomide, this first enter the German market in 1957 over the

counter as OTC for nausea.

The drug was marketed under the name Grippex, which contained

a combination of thalidomide, vitamin C, acetylsalicylic acid,

quinine and phenactin.

Researchers at Grunenthal also discovered that thalidomide could

relieve morning sickness in pregnant women



Thalidomide was found to cause deformity in children born to

mothers who took the drug and affected over 10,000 babies.

These babies were born with missing or abnormal limbs, feet or

hands. Other defects included abnormal or absent ears, heart and

kidney problems, cleft palate, spinal cord defects and digestive

system disorders.


In march 1962 the drug was banned in most countries where

previously sold. In July 1962 president Kennedy presented

“federal civilian service medal” to FDA inspector Frances Kelsy

who prevented drug approval in the U.S.

These three tragedies were responsible for the establishment of the

Good manufacturing practices (GMP’s).


33

GMP Vs cGMPs

GMP’s have been accepted and followed by most of the countries

to attain global standards, and to assist in giving people

healthcare and pharmaceutical products that are of similar

quality.

GMP’s have become a necessary to export healthcare products

between more than 100 countries of the world. It has become a

trend to refer to GMP as cGMPs.

Here, c refers to current rules and regulations that serve strictly

follow the guidelines and manufacturing procedures that are

current and most up to date.



The use of c as a prefix to GMP is a an attempt.

Regulating authorities especially manufacturers who agree to

follow the guidelines but still use 20-25 year old machinery and

equipment to produce healthcare products.

GMP forced many manufacturers to give up on old practices and

switch over to latest production processes.

It has also helped in avoiding contamination, errors and mix ups while at the same time helping in production of highest quality healthcare and pharmaceutical products.


35

Current good manufacturing practices

The WHO drafted its good manufacturing practices for the

manufacture and quality control of drugs in 1967.

QA & QC departments develop and follow standard internal

operating procedures directed towards assuring the quality, safety,

purity, and effectiveness of drug product.

GMP is also sometimes referred to as "cGMPs".

The FDA has issued a primary regulations to the industry entitled

current good manufacturing practice.

http://pharma.about.com/od/D/g/Drug-Master-File-Dmf.htm



36

cGMPs follows

cGMPs are followed by pharmaceutical and biotechnology

companies to ensure that their items are manufactured to specific

requirements including identity, strength, quality, and purity.

There are a number of federal regulations that relate to cGMPs

which, if not followed, can lead to criminal penalties.

Two specific regulations that relate to pharmaceutical

manufacturers.1.biological products,

2. Regulations that regulates of electronic records and electronic

signatures.



37

Good manufacturing practice Current good manufacturing practices

GMP refers to Goods

Manufacturing Practices that are

guidelines followed by over 100

countries

GMP applies to pharmaceutical

and healthcare products and help to

maintain high standards in these

products.

cGMPs is current goods

manufacturing practices that need

to be followed by participating

countries.

cGMPs is to remind accepting

countries that all guidelines must

be followed with latest and current

production processes.

Difference between GMP and cGMPs


Components of cGMPs The components of cGMPs are as the following-

1. Quality management.2. Quality control.3. Sanitation and Hygiene.4. Validation.5. Complaints. 6. Self-inspection and Quality audit.7. Personnel.8. Premises.9. Equipment.10. Documentation.


39

GMP (OR) cGMPs regulations

In March 1979, the FDA issued revised GMP regulations.

The federal Food, Drug, and cosmetic act states that a drug is

deemed to be adulterated during the production.

FDA ensures the quality of drug products by carefully monitoring

drug manufacturers' compliance with its Current Good

Manufacturing Practice (CGMP) regulations.

FDA can issue a warning letter against a company that fails to comply with Current Good Manufacturing Practice regulations.



40

Code of federal regulations

The regulations document the actions of drug sponsors that are

required under Federal law. 21 Code of Federal Regulations Part 210. Current Good

Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs.

21 Code of Federal Regulations Part 211. Current Good Manufacturing Practice for Finished Pharmaceuticals.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=210.1

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211



Some of federal regulations

211.42 design and construction features

211.46 ventilation, air filtration, air heating, and cooling

211.56 sanitation

211.58 maintenance

211.65 equipment construction

211.67 equipment cleaning and maintenance

211.87 retesting of approved components, drug product

containers, and closures.

211.111 time limitations on production


42

References

The science & practices of pharmacy volume-2 – Remington. (pg. no. 1018-1024)

Advanced pharmaceutical analysis – Dr. G. Devala Rao. (pg.no. 270-

272).

http://www.fda.gov/Drugs/DevelopmentApprovalProcess.

www.intechopen.com.

https://www.youtube.com/watch?v=GVyooqOYS7a

http://pharma.about.com/od/C/g/Current-Good-Manufacturing-Practices-Cgmps.htm

http://www.fda.gov/Drugs/DevelopmentApprovalProcess

http://www.intechopen.com/

https://www.youtube.com/watch?v=GVyooqOYS7a



Total quality management (TQM), and current Good Manufacturing Practice (cGMP) for pharmacy students

Education