Page 8 - QA and QC

GMP Training – Quality Assurance and Quality Control by www.gmpsop.com

completing manufacturing and testing records accurately and thoroughly
Responsibility for quality

Traditionally, GMP has emphasized that the responsibility for quality ultimately
rested with the QA and QC groups. However, managers, supervisors, process
operators, and support staff all have a role in assuring product quality. Every
time a product is handled. Inspected, tested, or processed, the potential exists
for quality to be affected. Therefore, GMP regulations require:

the need for suitably qualified personnel in every aspect of manufacture

production staff having a role in GMP compliance checking

QC testing being built into manufacturing processes

Despite quality being everyone's responsibility, all codes of GMP insist that a
separate department (independent of production pressures) oversee and manage
the QA systems, and take final responsibility for the quality of batches released
to the consumer.

Companies therefore will usually have some combination of a QA department
and QC laboratory.

GOOD TO KNOW – QA SYSTEMS

The QA systems:

implement checks and balances during operations

review documentation and master batch records

organize the systems that prevent errors and product failures

investigate defects and deviations jointly with production

organize and review auditing and corrective action programs

release product for sale

Knowledge and GMP behavior

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