Quality control and Quality assurance in Drug production How to design quality design improvement

1. Prepared by
MARUNGI ELISHA
At CITY COLLEGE OF HEALTH AND ALLIED SCIENCES
DAR-ES SALAAM, TANZANIA

2. Quality assurance (QA) is a way of preventing
mistakes or defects in manufactured products
and avoiding problems when delivering solutions
or services to customers OR part of quality
management focused on providing confidence
that quality requirements will be fulfilled.
Quality control (QC) is a procedure or set of
procedures intended to ensure that a
manufactured product or performed service
adheres to a defined set of quality criteria or
meets the requirements of the client or customer.

3. Quality Assurance
1. In quality assurance, you
plan to avoid the defect in
the first place.
2. Quality assurance is all
about prevention.
3. Quality assurance is a
process based approach.
4. Quality assurance involves
processes managing
quality.
Quality Control
1. On the other hand in quality
control, you try to find defects
and correct them while making
the product.
2. Quality control is all about
the detection.
3. Quality control is a product
based approach.
4. Quality control is used to
verify the quality of the
product.

4. Quality Assurance
1. Quality audit is an example
of quality assurance.
2. The goal of the quality
assurance process is to
develop a process so that
defects do not arise when
you are producing the
product
Quality Control
1. Inspection and testing are
examples of the quality
control process.
2. Quality control identifies
the defects after the
product is produced but is
not yet released or is still in
the production phase.

5.  Poor designed and developed of pharmaceutical
products in a way that not takes account of the
requirements of GMP and other associated codes
such as those of good laboratory practice (GLP)1
and good clinical practice(GCP)
 Improper storage and distribution of the products
maximizes any risk to their quality
 Lack of post-marketing surveillance that causes
difficult investigated quality defects and
appropriate measures not taken in respect of the
defective products to prevent recurrence

6.  Improper equipments and premises located,
designed, constructed, adapted, and maintained
to suit the operations to be carried out also
increase risk in control management system.
 Poor sanitation and hygiene from personnel,
premises, equipment and apparatus, production
materials and containers all become a source of
contamination to the product
 The manufacturer lack an adequate number of
personnel with the necessary qualifications and
practical experience.

7. Step 1: Identify Organizational Goals
The process of quality assurance starts by defining how employees’
jobs are tied to your company or organizations goals. Employees
need to know the organization’s mission, vision, values, how they
relate to the company and their role in it.
Step 2: Identify Critical Success Factors
The factors that make an organization’s quality assurance
system successful should be identified. These factors can be a well-
designed production process, great product, technical
support, customer support, financial security, or employee
satisfaction. Make a list of the primary factors that influence the
process of quality assurance in order to continuously and
consistently manage those factors.

8. Step 3: Identify Internal and External Customers
Identify the key groups of customers that make your quality assurance
system work. Knowing these customers and their needs can help
you develop programs and services for these people.
Often customers are vendors, suppliers, employees, volunteers or
direct customers.
Step 4: Customer Feedback
Customer feedback is essential in the process of quality assurance.
Consistent customer feedback enables organizations to detect and
solve quality problems before it become a serious issue.
Customer feedback could be obtained through regular customer
surveys, by phone, email, focus groups or in person.

9. Step 5: Implement Continuous Improvements
Quality assurance is synonymous with continuous improvement. The results or information
gleamed from an organization’s survey or other customer feedback tools must now be used
to make the necessary changes to the quality assurance process.
The essential factor is to study the feedback received and uses it to continuously improve the
organizations processes in delivering the products and services it sells to its customers.
Step 6: Select Quality Management Software
Select quality assurance software that not only helps you to implement a quality assurance
process, but also helps you to maintain and improve the process.
Step 7: Measure Results
Though there may be many reasons for implementing a process of quality assurance, one of your
main goals is to ensure your organization meets the needs of your customer. When an
organization does not reach this goal, it is difficult to show a positive ROI and the existence of
the organization is brought into question.
Right from the first moment make sure that there are measurable goals and everyone involved
knows what needs to be achieved. When they are not achieved, make sure everyone is clear
on what required corrective action is necessary to ensure customer assurance and
satisfaction

10.  Through strict documentation and procedures, our engineers
and operators maintain control of quality throughout every
step of production. The quality control process is divided into
three separate processes, ensuring that specialized expertise
is applied to each stage of our operation. This system also
provides the redundancy necessary to prevent any quality
problem from evading detection.

11. 1.Incoming Quality Control ( IQC )
 It is the job of the IQC process to conduct inspections and
handle quality issues before the assembly process starts.
Specific tasks of IQC include:
 Perform approved vendor list check
 Evaluate supplier quality records
 Perform sampling of incoming materials standard
 Perform dimension, visual and functional inspection of
material sample
 Monitor quality control chart of inspected properties and
alert engineering staff of significant deviations
 Continuously enhance the IQC process.

12. 2.In-Process Quality Control ( IPQC )
 Our IPQC process governs our quality systems during the
assembly process in order to detect and handle any
problems that may arise during assembly.
Specific tasks of IPQC include:
 Perform inspections on assembled and in-process materials
according to the standards
 Conduct in-line automated and manual inspections
 Apply first-article inspection after process setup
 Utilize statistical control techniques and watch for
significant deviations
 Perform in-process audits to ensure processes are up to
standard, and to identify factors needing improvement.

13. 3.Outgoing Quality Assurance ( OQA )
 Is the last process before products ship to customers, and
hence is very important in ensuring our shipment is defect-
free. Numerous redundancies with IQC and IPQC exist here
to ensure the validity of previous processes.
Specific tasks of OQA include:
 Perform visual and functional inspection
 Verify first-article inspection
 Repeat approved vendor list check;
 Apply sampling based on the standard
 Conduct reliability testing
 Submit failure analysis reports and alert engineering staff.

14. Quality by design (QbD) is a concept first
developed by the quality pioneer Dr. Joseph M.
Juran. Dr. Juran believed that quality should be
designed into a product, and that most quality
crises and problems relate to the way in which a
product was designed in the first place.
Woodcock defined a high-quality drug product
as a product free of contamination and reliably
delivering the therapeutic benefit promised in
the label to the consumer.

15. (1) A quality target product profile (QTPP) that identifies the critical quality
attributes (CQAs) of the drug product
(2) Product design and understanding including identification of critical
material attributes (CMAs)
(3) Process design and understanding including identification of critical
process parameters (CPPs), linking CMAs and CPPs to CQAs fig. below
(4) A control strategy that includes specifications for the drug substance(s),
excipient(s), and drug product as well as controls for each step of the
manufacturing process
(5) Process capability and continual improvement. QbD tools and studies
include prior knowledge, risk assessment, mechanistic models, design of
experiments (DoE) and data analysis, and process analytical technology.

17. The goals of implementing pharmaceutical
QbD are to reduce product variability and
defects, thereby enhancing product
development and manufacturing efficiencies
and post-approval change management. It is
achieved by designing a robust formulation
and manufacturing process and establishing
clinically relevant specifications