BTP4173

PROCESS CONTROL

QUALITY
ASSURANCE

BY GROUP 1, 3, 5, 7, 9, 11, 13 & 15

DEFINITION
The maintenance of a desired level of quality in a
service or product, especially by means of attention to
every stage of the process of delivery or production.

Quality assurance is a way of preventing mistakes and

defects in manufactured products and avoiding
problems when delivering products or services to
customers; which ISO 9000 defines as "part of quality
management focused on providing confidence that
quality requirements will be fulfilled".
 FOCUS

The system of quality assurance in manufacture of

pharmaceutical products focuses on the
proactive/preventive actions in the process of
manufacturing.

It is to prevent any defects before they occur when

manufacturing the product.
ACTIVITIES
PLANNING
Design a quality assurance plan template or procedures (tool to
assure quality in facilities) and monitor problems and drawbacks
that may appear during the implementation process.

AUDITING
A quality audit is a regular, systematic
PHARMACEUTICAL review of pharmaceutical activities to
identify whether these activities are
INDUSTRY performed in line with the procedures
and regulatory requirements.

Examine and investigate a certain project activity and identify

what enhances the activities value. Assuring process
performance, quality improvement plan and in documentation
program.
ANALYZING
GOALS

To set procedures and processes in place that will minimize risk.

Prevent. any predictable defects from happening.

Ensuring that pharmaceutical products are safe and

effective.
 OBJECTIVES

To identify product and process

improvements.

To ensure that the products are designed and

To ensure that the correct starting and
developed in accordance with GMP, GLP
packaging materials are implemented.
and GCP.

To ensure that the production and To determine that the consistency of

control operation are clearly specified the existing process is achieved.
in SOPs.
ROLE IN PHARMACEUTICAL INDUSTRY

Must determine that the product meets all the applicable specifications and that it
was manufactured according to the internal standards of GMP.
RO
LE
01
Helps to identify and prepare the necessary SOPs relative to the control of
quality. RO
LE
02

To coordinate with the manufacturing department in controlling their process and

products at every stage of manufacturing to meet the established specifications RO
through testing, auditing and reporting. LE
03

Responsible for the records and release functions of the QA department which
includes: RO
a. Maintenance of records of manufacturing procedures for each batch LE
manufactured, records.
04
b. b. Records of release, quarantine or rejection of components and finished
products based on QA test results.
ORIENTATION

PROCESS- ORIENTED
Quality assurance is process-oriented that aims to prevent
quality defects. Quality assurance mainly focuses on the
production by implementing quality policies and
procedures during the product is manufactured. The
organization tries to detect any issues in the quality at each
stage of production to ensure the defects can be detected
earlier and help to save cost and time.
THANK YOU