DIFFERENCE BETWEEN QA
AND QC
PRODUCT QUALITY REVIEW
QUALITY RISK MANAGEMENT
PRESENTED BY: MAHAM JAHANGIR
ROLL NO: 06331713013
• DIFFERENCE BETWEEN QC AND QA
QUALITY ASSURANCE QUALITY CONTROL
DEFINITION
• QA is a set of activities for ensuring • QC is a set of activities for ensuring
quality in the processes by which quality in products. The activities focus
products are developed. on identifying defects in the actual
products produced.
• QA is a managerial tool and overall setup • QC is a corrective tool and lab based
based only.
QUALITY ASSURANCE QUALITY CONTROL
THEIR GOALS AND MAIN FOCUS
• QA aims to prevent defects with a focus on • QC aims to identify (and correct) defects in
the process used to make the product. It is a the finished product. Quality control,
proactive quality process. therefore, is a reactive process.
• The goal of QA is to improve development • The goal of QC is to identify defects after a
and test processes so that defects do not arise product is developed and before it's released.
when the product is being developed.
QUALITY ASSURANCE QUALITY CONTROL
HOW DOES IT WORK
• Prevention of quality problems through • The activities or techniques used to
planned and systematic activities achieve and maintain the product quality,
including documentation. process and service
• Establish a good quality management • Finding & eliminating sources of quality
system and the assessment of its problems through tools & equipment so
adequacy. Periodic conformance audits that customer's requirements are
of the operations of the system. continually met.
QUALITY ASSURANCE QUALITY CONTROL
RESPONSIBILITY
• Everyone on the team involved in • Quality control is usually the
developing the product is responsible for responsibility of a specific team that tests
quality assurance the product for defects.
EXAMPLE
• Verification is an example of QA. • Validation is an example of QC
PRODUCT
QUALITY
REVIEW
• Regular periodic or rolling quality reviews of all licensed medicinal products should be conducted for
verifying the consistency of the existing process, the appropriateness of current specifications for both
starting materials and finished product to highlight any trends and to identify product and process
improvements.
• Such reviews should normally be conducted and documented annually, taking into account previous
reviews, and should include at least
REVIEW OF STARTING REVIEW OF CRITICAL REVIEW OF FAILED
MATERIAL IN-PROCESS BATCHES
• A review of starting materials • A review of critical in-process • A review of critical in-process
including packaging materials used controls and finished product controls and finished product
in the product, especially those from results results
new sources.
REVIEW OF REVIEW OF CHANGES REVIEW OF
DEVIATIONS • A review of all changes VARIATION
• A review of all significant carried out to the processes or • A review of Marketing
deviations or non-conformances, analytical methods. Authorization variations
their related investigations, and
submitted/granted/ refused,
the effectiveness of resultant
corrective and preventative including those for third
actions taken. country (export only)
REVIEW OF ADEQUACY REVIEW OF REVIEW OF STABILITY
• A review of adequacy of QUALIFICATION STATUS • A review of the results of the
any other previous product • The qualification status of stability monitoring program
process or equipment relevant equipment and and any adverse trends
utilities, e.g. HVAC, water,
corrective actions compressed gases, etc.
QUALITY RISK
MANAGEMENT
“Quality risk management is a systematic process for the
assessment, control, communication and review of risks to the
quality of the medicinal product”
• The quality risk management system should ensure that the
evaluation of the risk to quality is based on scientific knowledge,
experience with the process and ultimately links to the protection
of the patient
• The level of effort, formality and documentation of the quality risk
management process is commensurate with the level of risk.
STEPWISE APPROACH TO QRM IN PHARMACEUTICAL
INDUSTRY
Identify
Gather Analyze
risk and Commun
data and Organize and Control Risk
prepare icate the
knowledg the data evaluate the risk review
risk risk
e the risk
register
