Documentation
In GMP environments, if it’s not written down, it didn’t happen.
What is documentation?
This “GMP” standard must be followed in manufacturing therapies for human use.
What is Good Manufacturing Practice?
This must be done to your hands before entering an aseptic cleanroom.
What is hand washing or sanitizing?
This alcohol solution is commonly used to disinfect surfaces and gloves in cleanrooms.
What is 70% isopropyl alcohol?
You must write clearly and in this color of ink for all GMP records.
What is Blue or Black Indelible Ink?
Before releasing a batch, this team reviews the data to ensure everything was done correctly.
What is Quality Assurance (QA)?
You must wear this type of clothing to avoid contaminating cleanroom environments.
What is gowning (or sterile gown/coveralls)?
The air in cleanrooms is filtered using this type of filter.
What is a HEPA filter?
When you make a mistake on a record, you should do this instead of using correction fluid.
What is cross it out with a single line, write the correction, initial and date it?
This type of deviation must be reported right away and can impact product safety or patient health.
What is a critical deviation?
Touching sterile surfaces with non-sterile gloves can lead to this.
What is contamination?
This type of contamination comes from people, surfaces, or tools.
What is non-viable (particulate) or viable contamination?
When documenting it's important to record data when the task is done.
What is contemporaneous (or on time)?
This investigation process determines why a deviation happened.
What is a root cause analysis?
In aseptic areas, movements should always be slow and this.
What is controlled?
These regularly scheduled tests check surfaces and air for bacteria or fungi.
What is environmental monitoring?
These two types of records must always match: the one doing the work and the one checking it.
What are the operator's and the verifier's records?
This document type defines how to perform a process step-by-step and is followed during production.
What is a Standard Operating Procedure (SOP)?
This invisible hazard is the main reason for strict aseptic techniques.
What are microorganisms (or microbes)?
This validated process kills microorganisms and makes tools or materials safe for aseptic use.
What is sterilization (e.g., autoclaving or gamma irradiation)?