Quality assurance 4 Flashcards
What individual parts does the laboratory management programme cover?
Facilities are adequate
Equipment and instrumentation are qualified and well-maintained
Written procedures are in place
Personnel are adequately trained to do their jobs
Data are properly recorded, retained, and are readily retrievable
Substances are properly labelled, handled and stored
GLP documents are living and controlled
What does the laboratory management programme ensure?
Quality systems help management control the laboratory environment and ensure the proper resources (type and amount) are made available for the design, conduct and maintenance of all GLP studies in compliance with the regulations
What is the design and intention of GLP?
To provide a platform on which to conduct the study that facilitates inspection
Quality system designs have workings that are transparent and it is desired that they have built-in mechanisms for traceability and accountability
What is the main tool used by the FDA?
Inspection of laboratories by FDA field inspectors
The FDA will typically perform a facility audit of a contract research laboratory that is providing analytical or bioanalytical support to GLP studies under contract with a sponsor, every two years
What do inspections from the FDA include?
Inspection of the QAU
Inspection of one other quality system
Inspection of specific studies in the lab
The inspection will be within normal business hours and without giving prior notice
How are the results published?
The FDA does not certify laboratories, but will make public the results of all findings including all non-compliances found
Those laboratories that are not in good standing will receive a warning letter
Those that fail to remove the deficiencies cited in the warning letter will be disqualified
How are people trained for a GLP study?
Persons working on a GLP study must be qualified to do so
Qualification may come via a combination of education, prior job experience, in house training, outside professional training and other forms of training
Training may be general, such as training on the GLP regulations, or highly specific, such as training on the HPLC technique or even a specific HPLC analytical method
Personnel assignments
Each individual engaged in the conduct of a nonclinical laboratory study must be able to perform his or her assigned functions and there must exist documented evidence
Personnel assignments are provided on company job descriptions, which are kept in the employee’s training file along with their CV
Employee qualifications are documented in the employee training file as they develop
GLP samples
It is required that an area in the laboratory be designated and clearly marked off for the receipt of GLP samples (test articles and control articles)
Samples are logged in and inspected to ensure that that sample meets the description on the paperwork attached, check samples are not damaged
Sample log
Entries are made into the sample log indicating: the date of receipt, storage conditions, study identification number, lot number, and quantity of material received
Finally, the sample is placed into the proper storage condition and made available to the analyst for testing
Reagents and solutions labels
For reagents and solutions, the regulations are clear: the label on each must indicate identity, titer or concentration, storage requirements and expiry date
What is the metrology program?
Must know what instrumentation and equipment were used to generate study data or to serve as environmental chambers to store test and control articles and reference standards, the condition of all such instrumentation and equipment during the study, and their qualification status during the study
How is the metrology programme facilitated?
Each instrument or piece of equipment is tagged with a unique identification number and a record is made of them
A template for an instrument and equipment tag is: the name of the instrument custodian, the room number of the lab where the instrument is located, the date of the last qualification, and the date when the next qualification is due
Qualification and standardization
The terms qualification and standardization are used interchangeably and include the more specific case of calibration. Instrumentation and equipment in the lab that are not intended to be used to support any GLP study, or not qualified for regulated use, or out of order, must be identified as such with a marker in clear view for the user and inspector
Logbooks
Additionally, a logbook is created for each instrument and kept under document control, meaning that each page is numbered, the creation of the logbook is recorded against a document control unit, and eventually the logbook is archived. The instrument logbook holds the history on the instrument including when it was qualified, cleaned, inspected and repaired
Instrument use log
Controlled by the document control unit (DCU), captures the name of the person using the instrument, date of use, study number for the study being worked on at the time of use and the workbook number associated with the use
Trouble shooting
Instrument use logs help in instrument trouble shooting, for example, by helping the lab to identify analysts or analytical methods that may be causing an instrument problem, and they can provide valuable information in the event that the instrument becomes involved in an investigation
Investigation SOP
Study director management will have a formal procedure in place, described in an SOP that defines the following: when to investigate, how to investigate, how to document the investigation, getting proper approval of the steps taken, and what to do with the results of the investigation
Investigation quality criteria
The following criteria are used to judge the quality of the investigation:
Was it a scientific investigation starting with a provable hypothesis and ending with conclusions supported by the data?
Do the results from the investigation either justify invalidating previously generated raw data or keeping the raw data as they stand?
Was the investigation documented well enough that an independent, objective scientist can review it and come to the same conclusions?
Corrective and preventative actions
The lab manager is responsible for:
logging and tracking all issues
assigning personnel the task of completing such actions
allocating appropriate resources for the completion of each on an as needed basis
following each action to completion
Document control unit
Controlling documents is necessary to ensure that proper written instructions are transmitted to the laboratory as well as for positioning the company such that it can accurately and completely reconstruct any study for the sake of an audit
