Industrial pharmacy Quality management systems

1. INDUSTRIAL
PHARMACY - 2
POWERPOINT PRESENTATION BY R. SHIVA SAI KIRAN
HALL. NO.256418881004
B. PHARMACY 4TH YEAR
MOTHER TERESA COLLEGE OF PHARMACY NFC NAGAR GHATKESER

2. TOPIC
Quality management
systems .

3. CONTENTS
1. Introduction
2. Quality assurance
3. Quality control
4. Good manufacturing practices (GMP)

4. INTRODUCTION
Definition of quality management :-
Quality management is the management function that
determines and implement s the quality policy . Which is
organized and authorized by top management .

5. INTRODUCTION
The basic elements of quality management :
1. A quality system having organizational structure, procedures,
processes and resources.
2. Is needed to ensure adequate confidence so, that the
product will satisfy the requirements of quality.
Quality management is interrelated to the concepts of Quality
assurance , Quality control and GMP .

6. QUALITY ASSURANCE
Definition of quality assurance :-
Quality assurance is a systematic and dynamic process of determining
whether a product or service which been developed meets the
specified requirements or not .
Quality assurance cannot assure the production of quality
products, but aims to maximizing the probability of production
process to continuously produce products that attain highest
standards of quality .
Quality assurance employes a set of policies and standard operation
procedures to regulate the quality .

7. QUALITY ASSURANCE
Like the quality of of raw materials ,product components ,
other services etc. In order to detect any defects before they
enter in to final product .
Quality assurance therefore increases the customers
satisfaction , company ‘s credibility , efficiency and work
process and enables a company to compete with the others

8. QUALITY ASSURANCE
Objective s of quality assurance :-
1. To achieve an effective quality assurance through continuous
self improvement and outcome assessment of performance .
2. To satisfy the customers with the service provided by the
company .
3. To determine whether the steps utilized to provide the
product or service are appropriate for the time and
condition .

9. QUALITY ASSURANCE
4. To achieve and maintain a level of quality that maximizes
industry’s. reputation with the customers .
5. To reduce the expenditure resulting due to reworking ,
delivery of faulty goods and call back action’s.
6. To ensure that each and every product reaching the
patient is safe , effective and of standard quality .

10. DEMING CYCLE
What is Deming cycle ?
It is the most important tool to determine quality assurance
is the PDCA cycle , which is also known as Deming cycle.
The cycle is considered as problem solving process
implemented by the pharmaceutical companies who aim at
continuous improvement .
Repetition of the cycle throughout the life time of the product
or service improves the company’s efficiency .

11. DEMING CYCLE
PDCA cycle for quality assurance stands for:
• Plan
• Do
• Check
• Act

12. DEMING CYCLE
1. Plan :- Objectives and processes required for the implementation
of the best alternative with quantifiable measure s of
improvement are established .
2. Do :- The established plans are implemented .
3. Check :- Implemented processes are monitored and evaluated by
testing the results against the predetermined factors .
4. Act :- If the results require any changes to be made, then the
action ‘s are taken for improvement .

13. QUALITY ASSURANCE RELATED TO WAREHOUSE
& STORAGE :
Why we need this ? (^_^)
To ensure the quality of the products, proper
warehousing and storage conditions are needed which are
according to GMP and other regulation ‘s .
The following conditions are to be adopted to ensure
proper storage of the goods .

14. QUALITY ASSURANCE RELATED TO WAREHOUSE
& STORAGE :
1. Storage premises
2. Specifications of the storage area
3. Receiving and dispatching area’s
4. Quarantine area
5. Sampling area

15. QUALITY ASSURANCE RELATED TO WAREHOUSE
& STORAGE :
6. Rejected product area
7. Instruments
8. Monitoring of the storage conditions
9. Record keeping / documentation
10. Stock rotation and control

16. QUALITY ASSURANCE RELATED TO WAREHOUSE
& STORAGE :
11. Stock dispatch and transport .
• Quality assurance related to manufacturing
process .
• Quality assurance related to packaging .

17. QUALITY CONTROL
• What is quality control ?
Quality control reefers to the process in which the product /
process quality is measured , compared with the standards and
is rectified if any differences arise.
Both QA and QC are mistakenly thought to be one , but have
certain basic differences. QA establishes the standard tests and
procedures which can help to ensure the quality of the products
and materials.

18. QUALITY CONTROL
Where as QC functions to test and measure the materials
and products. In simpler terms, QA is process – oriented
while QC is concerned with the product.
Both QA and QC groups follow the standard operating
procedures (sops) and GMP regulations. Which ensure the
achievement of pure ,effective, safe and quality products

19. QUALITY CONTROL
Requirements of a Quality assurance unit :-
1. QC unit should be staffed with highly qualified and well
experienced scientist and technicians.
2. The unit must possess appropriate equipment’s and
instrumentation.
3. Validated test methods should be made available to the QC
unit for testing raw materials and finished products.

20. QUALITY CONTROL
4. Detailed specifications relating to specific dosage forms
and manufacturing operations should be made available
based on these specifications, the tested raw materials and
products can be accepted (or) rejected.
5. It is necessary that the QC department is made to
operate freely, independent of any production demands.

21. QUALITY CONTROL
Roles and responsibilities of QC unit :-
1. Raw materials control
2. In – process quality control
3. Monitoring of environmental conditions
4. Control of packaging components
5. Finished products control

22. QUALITY CONTROL
6. Documentation (Record keeping)
7. Stability studies.
Good manufacturing practices (GMP) :-
The guidelines required for maintaining quality of drugs
are given under Good Manufacturing Practices (GMP) .

23. GOOD MANUFACTURING PRACTICES
In 1957 an outline of GMP was prepared which was modified
and implemented as Schedule M in1988. In December 2001,
Schedule M was again modified to the drugs and cosmetics
rules.
GMP refers to a series of principles and procedures for the
manufacture of drug substance’s, drug products, medical
devices,in vivo and in vitro diagnostic products and foods to
ensure that the products are consistantly Produced and
controlled to the quality standards appropriate to their use.

24. GOOD MANUFACTURING PRACTICES
Objective’s :-
1. To provide assurance of identity, quality and strength of
pharmaceuticals.
2. To assure that correct procedures have been followed.
3. To assure that pure, safe and effective products are
manufactured and distributed.
4. To provide the necessary documentation in a
comprehensible and accessible form.

25. GOOD MANUFACTURING PRACTICES
• Schedule M is mainly divided into two parts
Part-1(factory premises and materials)
1-A : specific requirements for manufacturing sterile
products.
1-B : specific requirements for manufacturing oral solid
dosage forms.
1-C : specific requirements for manufacturing of oral liquid
dosage forms.

26. GOOD MANUFACTURING PRACTICES
1-D : specific requirements for manufacturing topical
products.
1-E : specific requirements for manufacturing metered dose
inhalers.
1-F : specific requirements for premises, plant and materials
for manufacturing active pharmaceutical ingredients .
Part-2 (Requirements of plant and equipment)