Myth vs Facts cGMP Quiz

If it’s not written, it’s still done.

• Myth

• Fact

Answer explanation

If it’s not documented, it didn’t happen – documentation is proof of compliance.

GMP is only QA’s responsibility.

• Myth

• Fact

Answer explanation

GMP is everyone’s responsibility, from operator to management.

You can overwrite an entry with white ink if you made a mistake.

• Myth

• Fact

Answer explanation

Corrections must be made by striking through, not obscuring. Use a single line and sign/date.

Cleanroom garments should be worn only in designated areas.

• Myth

• Fact

Answer explanation

To prevent contamination, never wear cleanroom gear outside controlled zones.

It is acceptable to leave cleaning logs blank and fill them at the end of the shift.

• Myth

• Fact

Answer explanation

Entries must be real-time, accurate, and contemporaneous (ALCOA+ principle).

Sterile gloves can be reused between batches if they look clean.

• Myth

• Fact

Answer explanation

Gloves must be replaced per SOP, even if they appear clean. Visual inspection is not sufficient.

Line clearance before batch start is mandatory.

• Myth

• Fact

Answer explanation

To prevent mix-ups and cross-contamination, line clearance must be documented and verified.

Only critical deviations need to be reported.

• Myth

• Fact

Answer explanation

All deviations (minor or major) must be reported and investigated.

Labels can be handwritten if printed ones are not available.

• Myth

• Fact

Answer explanation

Handwritten labels increase risk of error and are not acceptable unless SOP-approved.

During an audit, it is okay to say “I don’t know” if you’re unsure.

• Myth

• Fact

Answer explanation

It is better to be honest and refer to your supervisor/SOP than to guess or give wrong information.