Total Quality Management & current Good Manufacturing Practice

Prepared By:-
Shoab Malek
Certified Quality Auditor &
Pharma Consultnat
Total Quality Management (TQM) and
current Good Manufacturing Practice (cGMP)

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.
Email:- Shoab.malek@gmail.com 2

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

TQM can also be defined as
1. Total : Every employee 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.

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.

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.

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

Key concepts
TQM
Systematic
approach
Integrated
system
Continuous
improvement
Effective
communication
trainingProcess thinking
Customer
satisfaction
Total employee
commitment
Team work
and quality
chain

• There are number of key principles that can be identified and
associated with the definition of the TQM, including:
TQM
principles
Quality
oriented
management
Satisfy the
customer
Satisfy the
supplier
Continuous
improvement

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.

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.

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.

Continuous improvement
• 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.

Continuous improvement
• 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
plan
Do
Study
Act

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.

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.

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

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.

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. Email:- Shoab.malek@gmail.com 20

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.

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.

why are GMP’s requirement?
Government requirement.
Ensure quality products.
Reduced rejects and recalls.
Satisfied customers.
Maintain manufacturing consistency.
Company image and reputation.

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.

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.

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 .

• 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.

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.

• 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 womenEmail:- Shoab.malek@gmail.com
30

• 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).

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.Email:- Shoab.malek@gmail.com 33

• 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.

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.

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. Email:- Shoab.malek@gmail.com 36

Difference between GMP and cGMPs
Good manufacturing practice
• 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.
Current good manufacturing
practices
• 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.

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.

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.

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.

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

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