CMC QA
What is SISPQ?
This quality system ensures medicinal products are consistently stored, transported, and handled under appropriate conditions.
What is GOOD DISTRIBUTION PRACTICE (GDP)?
This license granted by regulatory authorities legally allows a site to manufacture or import medicinal products and perform QP batch release.
What is a MANUFACTURER'S & IMPORT AUTHORIZATION (MIA LICENSE)?
An unexpected event that departs from an approved process.
What is a DEVIATION?
Who is MANDY?
Her lovely small cockapoo dog is named Peggy.
Who is ANGELA?
Maria, Mandy, and Helge belong to this team.
Who are the QMS Team?
This document defines quality responsibilities between a sponsor company and a contract manufacturer.
What is a QUALITY TECHNICAL AGREEMENT (QTA)?
This event occurs when a medicinal product is exposed to temperatures outside its approved storage conditions.
What is a TEMPERATURE EXCURSION?
This formal step transitions a manufactured batch from 'quarantined material' to 'patient-ready' safe, commercial or clinical supply.
What is QP BATCH CERTIFICATION / RELEASE?
This document describes the instructions, requirements, and responsibilities for a controlled GxP process.
What is a STANDARD OPERATING PROCEDURE (SOP)?
Jumped from an airplane from 14,000ft high.
Who is FAY?
Who is DEANNA?
Deanna, Veronica and Kamila are on this team.
Who are the CMC QA Team?
These assessments evaluate suppliers, systems, records, and GMP compliance to ensure quality expectations are met.
What are QUALITY AUDITS?
This action should be taken when a medicinal product is suspected of being damaged, compromised, or unsuitable for distribution.
What is QUARANTINE?
This individual holds ultimate personal and legal responsibility for certifying that a medicinal product batch has been manufactured in compliance with GMP and Marketing Authorization.
Who is the QUALIFIED PERSON (QP)?
Before a controlled document becomes effective, it must complete this document control process.
What is a DOCUMENT CHANGE CONTROL (DCC)?
Her favorite show is I love Lucy.
Who is MARIA?
Earned her student allowance writing for a newspaper.
Who is GIANNE?
Fay, Pavlina, and Szymon hold this title.
Who are the QPs?
This company manufactures Setmelanotide API for Rhythm.
Hint: They are located in Belgium.
Who is POLYPEPTIDE (PPL)?
This exercise tests whether a company can rapidly trace and reconcile distributed medicinal products.
What is a MOCK RECALL?
This specialized area within a facility controls particulate and microbial contamination to meet strict air quality standards during manufacturing.
If a revised SOP that requires training impacts your job responsibilities, this ACTION is required.
What is RE-TRAINING?
Met Dan Levy from Schitt's Creek in a Karaoke Bar.
Who is SZYMON?
She skipped 4th grade and went straight to 5th grade.
Who is VERONICA?
Who are the RPs?
These documents are reviewed by QA to make sure a manufacturing process consistently works as intended.
What are VALIDATION PROTOCOL AND REPORTS?
In Great Britain, this role provides GDP oversight for certain medicinal products imported from approved countries for wholesale distribution.
What is the RESPONSIBLE PERSON FOR IMPORT (RP(i))?
This official document states that a product batch meets its required testing specifications and standards, signed by a qualified person or QA representative.
What is a CERTIFICATE OF ANALYSIS (CoA)?
A complaint lacking evidence that the product failed to meet specifications may be classified as this.
What is a NON-JUSTIFIED COMPLAINT?
Met her partner in a Sicily train station while on vacation.
Who is PAVLINA?
Originally from a tropical country and has lived in NC, SC, CO, and MA. Only planned to stay in MA for a year before moving to CA, but 12 years later, still in MA. No more CA in the plan :(
Who is KAMILA?
When they were the age that their son is now, they participated in rock 'n roll dance competitions.
Who is HELGE?