Inspections And OSHA Flashcards
Audits are periodic, data-based, assessments to verify a companys compliance with regulations and guidelines conducted by the Quality Assurance group or by hired contractors. Which of the following is not audited by a drug manufacturers QA group?
A) Contract manufacturing organizations
B) Quality Control group, their laboratories and records
C) Manufacturing group, the production suite and their records
D) Department of Health laboratories
E) Raw material suppliers
D) Department of Health laboratories
What is true about employer responsibilities under OSHA regulations?
A) Employers should conduct safety training only in English, to encourage workers to use and understand English
B) Employers should discourage workers from reporting safety issues to OSHA
C) Employers should not allow workers to see OSHA inspection results since those are confidential
D) Employers should inform workers about chemical hazards through training, labels, and chemical safety data sheets
E) Employers should provide personnel protective equipment to workers at fair market prices
D) Employers should inform workers about chemical hazards through training, labels, and chemical safety data sheets
What is true of OSHA requirements for safety training?
A) Safety training can include training in proper handling of bloodborne pathogens, especially viruses
B) Safety training is required of self-employed people
C) Safety training is only required of newly hired, incoming personnel
D) Safety training is not required of temporary contractual workers
E) Safety training does not include training on the proper use of personal protective equipment (PPE)
A) Safety training can include training in proper handling of bloodborne pathogens, especially viruses
OSHA regulations require that all work-related fatalities be reported to OSHA within 24hrs.
A) FALSE
B) TRUE
A) FALSE
Certain biotechnology workers handle human blood that could potentially harbor bloodborne pathogens. What applies to OSHA standards for worker exposure to bloodborne pathogens?
A) It is unacceptable to store food and drinking water in work areas with possible bloodborne pathogens
B) HIV or Hepatitis B contaminated materials and lab coats can be disposed of in regular garbage bins
C) If workers are trained on chemical safety, they do not need to be trained on bloodborne pathogen work practices
D) Handwashing and eyewash stations are not required in work areas; the ones in restrooms will do
E) Workers not trained on bloodborne pathogen handling are free to enter laboratories where bloodborne pathogens maybe present
A) It is unacceptable to store food and drinking water in work areas with possible bloodborne pathogens
What is true of chemical safety data sheets?
A) Safety Data Sheets are developed and written by the customer who will use the chemical
B) Safety Data Sheets describe procedures for the synthesis of the chemical
C) Safety Data Sheets contain regulatory information about chemicals
D) Safety Data Sheets contain list of companies that use the chemical
E) Safety Data Sheets specifies the date that the chemical will expire
C) Safety Data Sheets contain regulatory information about chemicals
Which statement is not true? Since the implementation of the OSH Act:
A) Rate of workplace injury have steadily decreased
B) Public employers, including state universities like UH, are required to provide their employees with information and training on the hazardous chemicals in the workplace.
C) All companies have been in compliance with OSHA’s safety standards
D) OSH Act compliance saves lives and jobs!
E) OSH Act implementation has been saving employers’ money in the long run
C) All companies have been in compliance with OSHA’s safety standards
What applies to the 1953 Factory Inspections Amendment to the FDCA?
A) The FIA resulted from a Supreme Court lawsuit won by Cardiff, president of a generic drug manufacturing company
B) FIA required FDA inspectors to present a notice of inspection, or FDA Form-482
C) FDA inspectors are not allowed to take out any samples for analysis outside of the company premises
D) With the FIA, FDA inspectors are required to present a judge-issued warrant prior to conducting inspections
E) The amendment required that the observations made during the inspection be made confidential and available only to FDA officials
B) FIA required FDA inspectors to present a notice of inspection, or FDA Form-482
Which statement applies to FDAs directed type of inspections of drug manufacturers?
A) Directed inspections may be conducted in response to violations reported to the FDA
B) Directed inspections are also known as surveillance inspections
C) Directed inspections are routine inspections normally conducted every 2 years
D) Directed inspections involve examining only one of the system in CDER’s six-system inspection model
E) Directed inspections are conducted under FDAs bioresearch investigative mentoring program
A) Directed inspections may be conducted in response to violations reported to the FDA
The FDA follows a six system inspection model to assess a companys compliance with cGMPs, where the quality system is always inspected. Which is not one of the remaining five systems?
A) Facilities and equipment system
B) Production system
C) Design system
D) Quality system
E) Packaging and Labeling system
C) Design system
Audits tend to focus on records and other written documentation as they are evidence of compliance or non-compliance with cGMPs. What would be an example of a recording practice that is not compliant with cGMP?
A) Accurate data entry
B) Back dating of lab notebook entries
C) Test results which are consistent when reported in different documents
D) Recording deviations from the SOPs
E) Complete recording of data in batch records
B) Back dating of lab notebook entries
What is true of FDA Form 483?
A) Form 483 is issued if a manufacturer chooses to ignore an FDA warning letter
B) FDAs form 483 is also known as notice of inspectional observations
C) Drug manufacturers are expected to respond to the FDA with their proposed corrective actions within 30 days after receipt of 483
D) Through a Form 483, all of a companys profits from the sale of violative products are disgorged
E) A Form 483 is presented by FDA inspectors to management upon arrival at the manufacturing site
B) FDAs form 483 is also known as notice of inspectional observations
The FDA Ombudsman is involved in:
A) drafting and passing food and drug laws
B) issuing warning letters to non-compliant drug manufacturers
C) inspecting drug manufacturing facilities for compliance with regulations
D) addressing issues drug manufacturers may have about certain FDA citations
E) performing analysis of drug samples obtained by FDA inspection teams
D) addressing issues drug manufacturers may have about certain FDA citations
Which workplace hazard is the OSH Act not designed to protect workers from?
A) Blood-borned pathogens
B) Loss of limb from poorly designed equipment
C) Caustic chemicals
D) Heat or cold stress
E) Compensation below the cost of living
E) Compensation below the cost of living
What does not apply to OSHA and OSHA-enforced regulations?
A) OSHA regulations apply to USDA, EPA and FDA workers also
B) OSHA regulations apply to most private sector workers
C) Main goal in drug manufacturing is to minimize risks to drug product quality
D) OSHA regulations do not apply to self-employed workers
E) Employers must report to OSHA if there are more than 3 people hospitalized due to a work-related incident.
C) Main goal in drug manufacturing is to minimize risks to drug product quality
