Quality Systems
Quality Control
Quality Assurance
Data Integrity
Quality Shmality
100
The Quality System that manages issuance, version-control, and archival of GMP documents and records.
What is Document Control?
100
This program monitors microbial and particulate levels within manufacturing facilities and utilities to ensure manufacturing areas are in a state of control.
What is Environmental and Clean Utilities Monitoring?
100
The group that reviews and approves all quality testing to ensure conformance to methods and specifications.
What is QA Analytical?
100
This is the practice of analyzing samples until the desired results are achieved.
What is Testing into Compliance?
When a result fails to meet specification, an investigation is required to determine result validity. A result cannot be invalidated without determinate laboratory error. Justification and quality approval are required prior to any resampling or retesting. SOP-0010 (AFS), SOP-1345 (MFG), 21CFR § 211.192
U.S. v. Barr Laboratories (1993): "...additional retesting for purposes of testing a product into compliance is not acceptable. "
100
FDA issues this record to document observations upon completion of a regulatory inspection.
What is FDA Form 483?
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
200
The Quality System that guides documentation and investigation of failures and assessment of impact.
What is Deviation Management?
21CFR 211.192
200
The documented process of ensuring that an analytical procedure, process, or system consistently produces results meeting predetermined accuracy and precision for its intended use. It confirms a method is suitable for its specific application, such as raw material testing or drug quality control.
What is Method Validation?
200
The group that collaborates with manufacturing on-the-floor to resolve any issues real-time, reviews and approves batch records, and manages resolution of internal and client comments in batch records.
Who is QA Manufacturing?
200
Identification, traceability, signatures, and context are all key aspects of this ALCOA principle.
What is attributable?
300
The Quality System that manages the implementation of corrective and preventative actions.
What is CAPA Management?
300
The routine, pre-analysis verification process confirming that an analytical system (instruments, reagents, columns, and analysts) is functioning correctly and capable of producing accurate, reproducible data for a specific test on a given day
What is system suitability?
PD-0010
300
This group ensures materials meet the appropriate specification to release for GMP use in manufacturing operations.
Who is QA Raw Materials?
300
Data that is available only at the time of observation and is not retrievable from a documented source.
What is transient data?
400
The Quality System that manages implementation of modifications to product processes, equipment, and utilities.
What is Change Control?
400
These samples are collected throughout our processes and must be tested within 24 hours of collection.
What is bioburden / host purity?
400
This group supports changes, equipment qualifications, NPI/PRIs to ensure suitability for use in manufacturing operations.
Who is Quality Engineering?
500
This Quality System is the formal, documented decision-making process by a Quality Unit to determine the final status of products—released or rejected —based on compliance with specifications, test results, and manufacturing records.
What is Batch Disposition?
500
This system enables the electronic tracking and management of sample chain of custody, testing, and results.
What is LIMS?
500
Person at KBI Boulder accountable for ensuring all quality and manufacturing operations are performed in compliance with industry standards and Health Authority regulations.
Who is Jeff Lee?
500
The contextual information required to understand, interpret, and validate data, often described as "data that describes data". It is an essential component of data integrity, providing the "who, what, when, and why" of a record, such as timestamps, user IDs, and instrument settings.
What is meta data?
500
Personnel responsible for ensuring quality of the design, manufacture, and testing of product, including document issuance, equipment qualification and reliability, results generation / review / approval, investigation and CAPA management, accurate documentation of all tasks executed, and immediate escalation of any concerns.
Who is everyone?