Quality assurance 2

Question 1

What are the Good Laboratory Practice regulations?

Answer 1

They establish a standard of practice to ensure that results from the nonclinical laboratory study reported to the US FDA are valid and that the study report accurately reflects the conduct of the study

Question 2

What do the GLP regulations require?

Answer 2

They require that any test facility which conducts, or intends to conduct a regulatory study must be a member or prospective member of the UK GLP compliance programme

Question 3

What is regulatory study?

Answer 3

A study for which the regulatory authority, to whom the data will be submitted, requires that the study to be conducted in compliance with the principles of GLP

Question 4

Definitions of regulatory study

Answer 4

In which an item is examined under laboratory conditions or in the environment in order to obtain data on its properties or its safety with respect to human health, animal health or the environment
The results of which are for submission to the appropriate regulatory authorities
Compliance with the principles of GLP is required in respect of that experiment or set of experiments by the appropriate regulatory authorities

Question 5

What products do the FDA and the EPA regulate?

Answer 5

FDA- human drugs, medical devices, combination medical devices, biological products
EPA- pesticides, biocides, toxic chemicals

Question 6

Federal Food, Drug and Cosmetics act

Answer 6

Under the federal food, drugs and cosmetics act, the sponsor of the regulated product is responsible for establishing the identity, purity, strength, safety and efficacy of that product through appropriate laboratory testing

Question 7

What is a multifaceted study?

Answer 7

Many labs and investigators, complex analytical chemistry support etc.

Question 8

What is a disinfectant qualification?

Answer 8

The suitability, efficacy and limitations of disinfecting agents and procedures should be assessed. The effectiveness of these disinfectants and procedures should be measured by their ability to ensure that potential contaminants are adequately removed from surfaces

Question 9

Disinfectant qualification planning

Answer 9

Planning is an important part of the process of disinfectant qualification
Factors to consider when planning include:
Which chemical agent to use?
Which and how many microorganisms to use for the challenge test?
Which and how many hard surface to test?
What test method to use?

Question 10

Disinfectant qualification- choice of chemical agent

Answer 10

Factors to consider when choosing a chemical agent:
Operator safety
Cleaning ability of chemical agent
Compatibility with the surface to be disinfected
Types of in-house microorganisms in the aseptic facility
Residual activity of the disinfectant
Regulations

Question 11

Disinfectant qualification- test method

Answer 11

The US FDA expects evidence of efficacy of disinfectants. The validating data should support sanitization and disinfectant procedures
There are three basic methods for qualifying disinfectants: suspension test, carrier test, surface test
In order to validate the disinfectants effectiveness, manufacturers will often use a combination of test methods

Question 12

When does GLP apply?

Answer 12

Discovery of a potential drug: nonclinical laboratory studies- animal studies, including toxicological and safety pharmacological studies together with pharmacokinetic and bioavailability studies
Clinical human studies

Question 13

What is laboratory compliance?

Answer 13

Laboratory work in support of a GLP study is conducted by a qualified analyst, using a qualified instrument, and following a validated or verified analytical method or SOP

Question 14

The essentials to lab compliance

Answer 14

The procedure to qualify the analyst involves documenting in their training file proof of their qualification based upon a combination of their education, prior job experience and specific on the job training
The goal of qualifying the instrument is to show the instrument is fit for its intended use

Question 15

Lab compliance equipment

Answer 15

Equipment used for the generation, measurement or assessment of data shall be adequately tested, calibrated and or standardized

Question 16

Lab compliance analytical method

Answer 16

The procedure to validate or verify the analytical method may only require verifying that expected results are obtained when following the method as applied
When following a validation protocol in conformance with the appropriate ICH guidance to industry

Question 17

Lab compliance qualifications

Answer 17

All such qualification of either instruments or analysts must be thoroughly documented and the documents properly archived so that even years later it will be possible to demonstrate to the FDA the qualification status at the time of the study

Question 18

Roles and responsibilities

Answer 18

All aspects of a GLP study are regulated, from the experimental design, through sampling and performing chemical analyses, to recording, reporting, and archiving experimental results and conclusions
Those persons who have the power and responsibility to direct resources and to ensure that the study conduct is in compliance with GLP regulations are collectively called management

Question 19

What are the roles and responsibilities of management?

Answer 19

Management establishes a document control unit that ensures that any and all records used or generated in the conduct of the study and deemed necessary for its evaluation and reconstruction are controlled
Also establishes a quality assurance unit to monitor the study at appropriate intervals and report back on a timely basis any noncompliances to the study director

Question 20

What are the roles and responsibilities of the study director?

Answer 20

The study director serves as the single point of study control and is responsible for overall study conduct: study pan and design, technical conduct of the study, interpretation, analysis, documentation, reporting of the study results, archiving of study materials

Question 21

What are the roles and responsibilities of a principal investigator?

Answer 21

A principal investigator is the individual who is appropriately trained, qualified and experiences to supervise delegated phases of study
For a multi site study, PI acts on behalf of study director

Question 22

What are the roles and responsibilities of quality assurance personnel?

Answer 22

The site is inspected by QA personnel to ensure that the study is performed according to GLP
During the QA inspection the following documents are checked: SOPs, master schedule, study plan, final report
Type of inspections: study based, facility based and process based

Question 23

What is the purpose of written procedures?

Answer 23

Procedures provide written instruction to the user and are reviewed and approved by management and quality assurance
A periodic schedule of review and revision is established for all procedures
Furthermore, written procedures facilitate a quality audit that takes place after the study is complete

Question 24

What is the purpose of SOPs?

Answer 24

A testing facility shall have standard operating procedures in writing setting forth nonclinical laboratory study methods that management is satisfied are adequate to ensure the quality and integrity of the data generated in the course of a study

Question 25

Key SOPs include:

Answer 25

Document control
Training and qualification of analysts
Procedures for recording raw data
Corrective and preventative actions
Change control
Quality assurance monitoring of GLP studies

Question 26

Essential elements of SOP

Answer 26

Purpose
Responsibility of personnel
Reference to other related documents
Materials
Equipment
Procedure (step by step)
Approval

Question 27

What are analytical test methods?

Answer 27

Each laboratory shall have immediately available laboratory manuals and SOPs relative to the lab procedures being performed. Published literature may be used a s a supplement to SOPs.
Changes are annotated on the change control page of the method along with the justification for each change

Question 28

The study final report

Answer 28

Includes:
A statement of the objective of the study
A description of all methods employed
All of the experimental data and results generated in the conduct of the study
Descriptions of all calculations
All conclusions drawn