Contamination
This is the unintended introduction of undesirable materials into a product.
What is Contamination?
Employees should always remove this before entering production.
What is jewelry?
The acronym GDP stands for this.
What is Good Documentation Practices?
Equipment should never be used if it contains this from a previous batch.
What is product residue?
This famous GMP saying reminds us that undocumented work is unacceptable.
Answer: What is "If it isn't documented, it didn't happen."
The first thing you should do after discovering an error.
What is report it immediately?
GDP stands for this.
What is Good Documentation Practice?
The primary reason pharmaceutical and supplement manufacturing companies maintain a strong quality culture.
What is patient protection.
Hair, glass, metal, and insects are examples of this type of contamination.
What is physical contamination?
You should change your gloves after doing this.
What is touch your face of anything that could potentially contaminate product?
Prefilling or backdating data fields on a batch record is considered this.
What is falsification?
This activity ensures all materials and labels from the previous product have been removed before the next lot of production begins.
What is line clearance?
These are to be documented when equipment is service.
What are repairs?
Preparing work, following procedures, and double-checking calculations support this philosophy.
What is Right First Time (RFT)?
True or False: Codis' Seymour Site manufactures medical devices.
What is True?
If you cannot confidently stand behind the quality of a product, do this.
What is stop work and report the concern?
Cleaning agents and lubricants are examples of this type of contamination.
What is chemical contamination?
Employees should do this if they symptoms of illness.
What is call in and stay home?
You should do this if you cannot follow your SOP or batch record as written.
What is STOP and notify your supervisor or Quality?
Missing labels, damaged equipment, and product residue are reasons for this.
What is stop, report the issue, and do not use the equipment?
Cleaning, inspections, deviations, and environmental monitoring should all be this.
What is documented.
Instead of asking "Who made the mistake?" ask this question.
"What allowed the mistake to happen?"
SISPQ stands for this.
What is Safety, Identiy (or Integity), Strength, Putiry, and Quality?
Besides patients, a strong quality culture also protects employees, compliance, reputation, and this.
What is business success?
Mold, yeast, bacteria, and biofilm are examples of this contamination category.
What is microbiological contamination?
Dirty gloves spread contamination just like these.
What are dirty hands?
Materials must be identified as _______ by Quality before use in Manufacturing.
What is released?
Before equipment can be used, it must be clean and this.
What is verified clean?
these are two things you should never do to GMP records.
What is backdate or obliterate data?
This phrase is often a warning sign of _________________: "We've always done it this way."
What is a weak quality culture?
ALCOA stands for this.
What are Attributable, Legible, Contemporaneous, Original, and Accurate.
Name the four questions you should ask before making a quality decision.
Is it safe? Is it compliant? Would I be comfortable explaining this during an inspection? Would I take this medication or give it to a loved one?
Name four common sources of contamination found in a pharmaceutical facility.
What are (any four, including but not limited to) personnel, equipment, facility, materials, dirty hands, HVAC failures, water leaks, poor housekeeping, damaged packaging.
Name four required gowning items commonly worn before entering production.
What are (any four) hair net, beard cover, gloves, lab coat, dedicated shoes or shoe covers, safety glasses?
Name 5 of the 10 qualities of good documentation.
What is permanent, legible, accurate, prompt, clear, consistent, complete, direct, accessible, and true?
List four items that must be verified during line clearance before production begins.
What is (any four) previous product removed, labels removed, packaging removed, equipment clean, documentation complete?
Name four situations that should be immediately reported because they may indicate contamination.
What are (any four) unknown material, damaged packaging, equipment leaks, pest activity, broken glass or plastic, missing labels, dirty equipment.
Name three positive GMP behaviors that strengthen quality culture.
What are (three of the following) report mistakes immediately, ask questions, stop work when indicate by issues, follow procedures, document accurately, help coworkers, learn from deviations.
If this cannot be trusted, then neither can the product.
What is data?
While dispensing raw material into an open product container, an operator notices that a screw has fallen from an overhead piece of equipment and cannot be located. What should they do?
What is stop the operation immediately, notify Quality and supervision (who will place the material on hold and ensure an investigation is initiated before production resumes)?