The document discusses quality management systems in the pharmaceutical industry. It provides an overview of key aspects of quality management including Quality by Design (QbD), Total Quality Management (TQM), ISO 9000 and ISO 14000 standards. The main points are: 1) Quality management systems (QMS) rely on regulations and guidelines to ensure product and process quality in the pharmaceutical industry. 2) QbD and TQM approaches aim to increase manufacturing efficiency and product quality through systematic process understanding and employee involvement. 3) International standards like ISO 9000 specify quality management principles for meeting customer and regulatory requirements, while ISO 14000 provides an environmental management system framework.

1. Presented by :- Nabi Hasan
B.Pharm. (7th Semester)
ASU2017010100233
Industrial pharmacy –II
( BP702T/PHS702 )

2. QMS allows documenting and implementing the procedures for an organization to
attain the goals.
Quality Management System (QMS) is one of the important aspect of a pharmaceutical
industry for maintaining the quality and safety for their products and services.
QMS relies on the regulations and guidelines to maintain the effective quality of a
product
QUALITY MANAGEMENT SYSTEM:
Proper implementation of QMS will ensure the better service and customers’ satisfaction

3. •Due to the effect of globalization, market competition, supply and demand, complexity of supply
chain system and development of international guidelines and regulations,
• The environment of pharmaceutical industry is changing day by day.
• The quality, safety and efficacy cannot be ignored or compromised as pharma industry is directly
concerned with the patients to provide them zero defect products.
Why QMS ?
Quality :- A/c to US FDA “Quality is a measure of product's or service’s ability to satisfy
the customer’s demand”

4. • ICH stabilished in 1990 in Brussel’s .
• Including members USA , European union , Japan .
•It is a unique agency in bringing together the Regulatory Authorities of various countries
and pharmaceutical industries to discuss the scientific and technical aspects of drug
registration.
•ICH guidelines is divided into four categories.
Q = Quality guidelines :- includes Stability , impurities testing, GMP.
S = Safety guidelines :- includes Carcinogenicity, genotoxicity , reprotoxicity.
E = Efficacy guidelines :- includes Clinical , Pharmacogenomics.
M = Multidisciplinary guidelines :- includes medical dictionary for regulatory
activity, electronic standards , non-clinical safety studies , common Technical
documents (CTD).
International Council for Harmonisation (ICH) :-

5. Total :- All employees have a common goal toward improving the quality of final product.
Management :- Top level management have to take proper decision toward a common
goal or objective.
8- Basic Principles of TQM:-
1. Consumer / Customer focus :- Management should understand customer needs &
Requirements.
2. Leadership :- management should create and maintain an environment in which
everyone can participate in achieving the organization goals.
3. Involvement of employee.
DEFINATION :-
 Total Quality Management (TQM) Is the continue process of detecting & reducing
or eliminating errors in manufacturing.
 Improving the customers- satisfaction and experiences.
 Streaming the supply chain management.
 Ensuring that total employees are involved in speed up quality of organization or
business.
Quality :- Quality as per customer demand .

6. 4. Process centered :- management should focus on process which is a series of steps from
input of raw materials from venders/suppliers to final products .
RAW MATERIALS MANUFACTURING QC TESTING
MARKETING TO CUSTOMER FINISHED PRODUCT
5. Integrated system :- responsibility of achieving quality in the business organization upon
each individual department
such as; R&D , Production , QA /QC , Marketing.
6. Strategic & Systemic approach :- To fulfill their ------ VISION , MISSION & GOALS .
7. Continuous improvement :- management should aim at steady incremental improvement .
8. communication :- proper communication with Raw material vendor's
Company staff's
Marketing team

7. Statistical Quality Control / Quality tools of TQM :-
It is implemented for the better quality in the organization :
a. Quality circle :- it includes a small group of human chain that are implemented to
do a particular quality task.
b. Cause and Effect diagram/ Fish bone diagram :- These are charts that identify
potential causes for particular quality related problems or
quality characteristics .
• Manager
• Supervisor
• Workers /labors

8. c. Flow chart :- Sequence of steps involved in an operation either production or quality
check. For eg. API production.
Input of Raw materials increase Temp. 40 degree Rxn. For 5 hrs
( at 40 degree )
(further process) add H2O Cool at 25 degree
d. Check list :- simple and effective tool to find common defects per shift per machine ,
per operator.
Through this method location of the particular defects can be identified
and the problems could be corrected in a focused way.
e. Control chart :- These are very important quality control tool used to evaluate weather the
process is operating within the defect values.
This chart has a certain value UPPER CONTROL LIMIT
LOWER CONTROL LIMIT
E.g. API production ; not less than 0.1% moisture & not more than 0.5% moisture .
here, 0.1% is lower limit
0.5% is upper limit

9. f. Scatter Diagram :- The scatter diagram graphs pairs of numerical data, with one variable on
each axis, to look for a relationship between them.
If the variables are correlated, the points will fall along a line or curve.
g. Pareto analysis :- few quality problems is important which need immediate attention where
as many others are not critical.
Advantages of TQM :-
1. Improve in quality and safety of the drugs.
2. Improvement of customer satisfaction.
3. Improvement of reputation of industry.
4. Total involvement of employee with higher moral and responsibilities.
5. Lower economic burden.
6. High Productivity & Decrease waste due to fewer defective products, etc.

10. Objectives of QbD :-
The main objectives of QbD are as follows:
1. Increasing manufacturing efficiency.
2. Increasing the efficiency in product development.
3. Enhancement of product quality and performances to meet patients’ needs.
4. Increase in process capability.
5. Avoidance of regulatory compliances.
6. Incorporation of risk management.
7. Reduction in production costs and waste.
8. Reduction in product variability, defects and rejections.
DEFNATION :-
According to US FDA and ICH Q8 (R2) the QbD is a systematic approach to development
which includes the prior knowledge of product and process understanding based on the
results of studies using design of experiments, use of quality risk management and use
of knowledge management.
The main outcomes of QbD are as follows:
1. Maintenance of product quality to meet expected clinical performances.
2. Maintenance of product quality by efficient manufacturing and formulation process.

11. Elements of QbD
The following elements can be included in the study of QbD:
1. QTPP (Quality Target Product Profile): This profile is related to quality, safety and efficacy.
2. CQAs (Critical Quality Attributes): The study of CQAs helps in the study and controlling of the
product characteristics that have impact on product quality.
3. Determination of CQAs of drug substances, excipients, etc. and the selection of the excipients to
attain the desired drug quality.
4. Suitable manufacturing process selection.
5. Risk assessment:
• CMAs (Critical Material Attributes)
• CPPs (Critical Process Parameters)
6. Defining a control strategy.
The pharmaceutical product should be produced with required quality in consistent fashion and the
control strategy ensures this. It includes the following elements:
1. Control of input material attributes viz., drug substance, excipients, packaging materials,
considering their utilization and effect on product quality.
2. Product specifications.
3. Controls of unit operations that have a role to maintain the product quality. The
operations may include granulation, drying, degradation, particle size distribution,etc.
4. In-process testing.
5. Finished product testing.
6. Testing of products at every stage at regular intervals (Monitoring program).

12. •The history of ISO though began in 1946, in 1947 ISO started officially its operation and
in 1951 the first ISO standard was published.
•International Organization for Standardization (ISO) is an international standard of QMS.
•This written international standard is implemented by ISO.
•It is an independent organization with more than 150 national standard bodies.
ISO 9000
• The ISO 9000 family of standards is designed to help organizations to ensure the
customers’ needs, the statutory and regulatory requirements.
• It does not certify any organization. It certifies the QMS of any organization.
• The basic quality management principles (QMP) of ISO 9000 are:

13. ISO 9000 Series
ISO 9000: Quality assurance and quality management concepts, guidelines for selection and use.
ISO 9001: Concepts for QA in design, production and development of the system, along with service
and installation.
ISO 9002: Concepts for QA in production, service and installation.
ISO 9003: Model for QA in final inspection and finished good testing.
ISO 9004: Guidelines for quality assurance and quality management planning, implementation,
efficiency and improvement.
Advantages of ISO Certification
1. Increment in marketability.
2. International recognitions.
3. Reliability in the market.
4. Capability of providing quality products to satisfy the customer.
5. Improvement in relationship with customers and stakeholders.

14. ISO 14000
• ISO 14000 family provides practical tools to manage the environmental responsibilities
of companies and organizations. It was initially published in 1996 and revised in 2004.
• This standard is related to Environmental Management System (EMS).
Principle of ISO 14000 :-
The principle of ISO 14000 is explained by PDCA Model ;
1. Plan: Designing of aim, objective and processes to achieve the desired result.
2. Do: Designed process should be performed step by step. The changes are noted and
data is stored to analyze the results.
3. Check: The evaluation of the data and results recorded in the previous steps.
4. Act: The evaluation of the data and results helps to improve the process.

15. Advantages of ISO 14000:-
• Better marketability.
• Better utilization of resources.
• Environmental responsibilities.
• Better quality of finished goods and products.
• Customers’ satisfaction.
• Enhancement of the reputation and reliability of the organization.
• Improvement of the relationship among management, employees, customers and
investors.
• Reduction in cost.
ISO 14000 Series :-

16. Process of ISO 14001 Certification :-

17. THE END