Following Procedures
Having Written Procedures
Document Your Work
Do You Know?
GMP is for Me
100
Use of gloves, safety glasses, and laboratory coats are a form of this.
What is PPE?
100
Procedures used by the facility for all materials and products.
What are SOP, TM, PMR, and Spreadsheets?
100
Generic form used to capture data and the form found in PMRs for data information.
What is Form # 0132 Test Data Sheet
100
Contaminated, mis-labeled, does not perform as expected, does not produce in compliance with FDA's regulations.
What is adulteration?
100
Voluntary registration that certifies the quality of our operation.
What is ISO?
200
Initial tasks performed daily before using an instrument.
What is Daily Maintenance?
200
The use of clear, legible, and correct documentation.
What is are GDP- Good Documentation Practices?
200
Used to request and document additional testing of materials.
What is IAR?
200
Any medical device (reagent, calibrator, control, instrument, or equipment) intended to be used outside of the body for the purpose of diagnosing a disease or health condition.
What is IVD (In-Vitro Diagnostics)?
200
This group controls the development, production, distribution, and use of products in the United States.
What is FDA?
300
This procedure is used to determine the compliance of data to specifications for product release and stability studies.
What is SOP QC-7086 for data review?
300
Blue and Black ink
What is the only colored ink allowed in paperwork?
300
Information required on every page of documented data.
What are Part #, lot #, initials, and date?
300
Any health care product that does not achieve its principle intended purpose by chemical action or by being metabolized
What is a Medical Device?
300
Regulations that establish minimum standards for the manufacture of our products to assist in preventing adulteration and protecting the health and safety of our customers.
What is GMP?
400
This procedure is used to investigate unsatisfactory results.
What is QC-1525 Verification of Out-of-Specification Performance Results?
400
Document that accompanies all raw materials.
What is COA?
400
The function in the electronic program, SAP, used to record results.
What is QE51N Results Recording?
400
Many international countries have now adopted this into their national regulations: Canada, European Union, Australia
What is ISO 13485?
400
A set of policies, procedures, and programs at Middletown that ensure the products we produce are safe, effective, and meet our customers' requirements.
What is a Quality System?
500
Single cross out line, initial/date
What is the correct way to mark-up a document?
500
This procedure is used to determine the continued suitability of raw materials for use in the manufacture of diagnostic materials.
What is QC-3502 Raw Material Re-test and Re-control?
500
A complete and careful examination of all records.
What is Audit?
500
Patients, doctor's offices, labs, etc........
What is our customers?
500
We, as employees of the Middletown facility, are committed to building and maintaining quality partnerships with our customers, suppliers and regulatory bodies. We will consistently produce and deliver quality products and services that meet or exceed our customer’s expectations and regulatory requirements. Our commitment to continuous improvement and the use of meaningful metrics will guild our business processes and our compliance to regulatory requirements.
What is our Quality Policy?
M
e
n
u