Principles of cGMP
Why is cGMP important?
To ensure QUALITY is built into the design and manufacturing process at every step.
We need to ensure _________ is built into the design and manufacturing process at every step.
Quality
Recall classification for dangerous or defective products that predictably could cause serious health problems or death.
Class 1 Recall
What type of Documents follow GDP?
2 examples
Multiple Answers:
Policies, Procedures, and Records, Training Documentation, Quality records (variance, incidents, etc.), Validation Documents (IQs, OQs and PQs), Laboratory Records, Test Records, Manufacturing records, product QC records, downtime donor qualification process
If I make a mistake on a record, I should...
• Drawing a single line through the error, initial and date.
• Write the correct information next to the error.
• Add a comment to clarify the mistake or correction if it is not clear.
The federal agency that developed cGMP regulations
Who is the FDA?
What evidence is used to show that an employee is trained and can adequately perform their assigned responsibilities?
Training Records!
A product has a minor violation that would not be subject to FDA legal action and is removed from the market or corrects the violation.
What is a Market Withdrawal?
Who is required to follow GDP?
Everyone who documents activities related to current Good Manufacturing Practices (cGMP)
If I notice a quality issue or don't understand something during a process, I should...
STOP the process and ASK/NOTIFY supervisor or management.
5 P's of cGMP
People, Premises, Product, Processes and Procedures.
Federal Food, Drug, and Cosmetic Act
3 main requirements
What are Pure, Safe, and Effective?
Name two (2) FDA imposed actions for violation to cGMP.
1. Fines paid
2. Jail sentences
3. Company Closure
What types of pens are acceptable when writing on any official document?
Non-water soluble blue or black pen
At what time should an operator sign and initial/date a step in a document?
Record all data at the actual date/time of performing the work.
Do not complete records in advance of performing the work (predating) or after the work has been performed (backdate) on any entry.
Elements of the Hologic Quality Policy
(List 4 Elements)
Quality excellence, product safety, regulatory compliance, and an effective Quality Management System.
What is the document number for the Quality Plan in ETQ?
POL-00114
What are two (2) repercussions of a recall?
Multiple Answers:
Costly to manage, Delayed Treatments, Lawsuits, FDA 483 Letter, Fines, Facility closure
All documentation must be
NEVER, NEVER, NEVER FALSIFY information
Falsification includes (3 parts!):
•Creating false statements
•Altering reports and records
•Omitting or modifying data intentionally
What can you and your team do to ensure that cGMP is being followed in your area daily?
(3 examples minimum)
Mulitple Answers:
Completing training, use of current procedures, accurate documentation, all equipment is maintained and calibrated, ensuring specifications and requirements are met, following GDP
Which documents must we have in the Quality Management Systemn(QMS) for compliance to the Quality System Regulation (QSR)?
(4 Part Answer)
The Quality Manual, Quality Policy, Quality Objectives, Training and Records.
What can happen when a document has GDP errors?
(3 examples minimum)
Multiple Answers:
Inaccurate data, Miscommunication, Delays in production and release, Nonconformance and Investigation, Nonconforming Product, Impact to customers, Lack of traceability.
How would you correct an calculation error on a document?
(3 Steps minimum)
1. Verify the calculation and the correct answer
2. Cross-out the error and initial and date
3. Enter corrected answer in the document
How do you verify a procedure that you are using is current?
(3 Steps)
1. Access the document in ETQ.
2. Verify Effective Date in ETQ matches the printed hard copy.
3. Print forms directly from ETQ when needed.