As per ISO 9000, Quality Control (QC) is defined as “A part of quality management focused on fulfilling quality requirements.”
WHO defines QC as, “The sum of all procedures undertaken to ensure
the identity and purity of a particular pharmaceutical.”
QC is the part of GMP that deals with developing specifications,
sampling input materials, intermediates, and finished products; testing them,
documenting results, and setting up release procedures to ensure that all
relevant testing has been performed and only products with ascertained quality
are released for use.
Objectives of Quality Control
The objectives of the QC department in the pharmaceutical industry
are to ensure that:
• There is a day-to-day control maintained over the quality
aspects of drug products.
• Incoming raw materials, in-process goods, and finished products
are all tested for compliance with predetermined quality specifications.
• Environmental monitoring is performed to make sure products are
manufactured, packed, and stored under prescribed conditions.
• Instruments are calibrated and working as expected.
• Analytical methods are developed and validated to ensure they
stay capable of providing results that are accurate and predictable.
Differences between QA and QC
|
Attribute |
QA |
QC |
|
Goal |
Preventing
defects. |
Identifying
defects. |
|
Focus |
Building
quality into the product from the design stage itself. |
Testing
if quality exists in the product after its manufacture. |
|
Workflow |
Establish
a quality management system and continuous monitoring of processes. |
Find the
source of problems in quality. |
|
Type of
tool |
Managerial. |
Corrective. |
Given the rapid pace at which the pharmaceutical environment is
changing today, companies must adapt to the quality requirements needed to
consistently manufacture and deliver products with zero defects. There can be
no compromise on the efficacy, quality, and safety attributes of drug products.
Developing, manufacturing, and selling a quality product is a collective
responsibility of everyone in an organization. This calls for an integrated
approach that includes building quality into a product by design, developing quality
management systems that are strictly monitored, and focusing on continual
improvement to meet consumers’ health requirements.