BTP4173 PROCESS CONTROL

QUALITY
CONTROL
GROUP 2,4,6,8,10,12,14
 DEFINITION

Quality Control is that part of Good

Manufacturing Practice which is concerned

with sampling, specifications and testing, and

with the organisation, documentation and

release procedures which ensure that the

necessary and relevant tests are actually

carried out and that materials are not released

for use, nor products released for sale or

supply, until their quality has been judged to be

satisfactory.
 FOCUS

QC aims to identify and improve the defects in

the finished product. Therefore, it is a reactive

process. Reactive means by which quality is

gauged and monitored.

 ACTIVITY

-Use control measurements to analyze and

evaluate the quality standards and

processes.

-Perform quality control assessments and

audits.

-Compare quality control measurements

against established control limits and

tolerances.

-Identify non-compliance and reasons for the

non-compliance.
 GOAL

-To identify defects after a product is developed

and before it's released.

-To test and verify the product quality against

predefined standards.
 OBJECTIVES

-To improve product quality to avoid the

-To test the drug at every stage of
poor quality products from reaching
production.
customers and reduce customer
-To identify and correct defects in the
complaints.
finished products.
-To optimize the technological procedures

used in manufacturing processes.

 ROLES IN PHARMACEUTICAL INDUSTRY

Evaluate the quality of raw materials and API, drug product, packaging components,

reassay and retain throughout the process.

Test the products and compare the results to the specification requirements by

performing the actual testing on raw materials and finished products.

Protect the consumer from defective products and the company from damage to its

reputation due to inferior manufacturing processes.

To coordinate with the manufacturing department in controlling the process and

products at every stage of manufacturing to meet the established specifications

through testing, auditing and reporting.

 ORIENTATION

PRODUCT-ORIENTED

Quality control is product-oriented, focusing on

identifying issues or defects in manufactured

products by testing to ensure the evaluation

seeks to assess performance through finalized

products meet the specific requirement. QC

also ensures that no material or product will be

released for sale or supply until their quality has

been evaluated and judged to be satisfactory.

THANK YOU