BTEC Quiz 12

Occupational Safety and Health Administration (OSHA) is an agency under the: a.Department of Labor b.National Institutes of Health c. Department of Energy d. Department of Defense e. Food and Drug Administration

a.Department of Labor

What does not apply to OSHA and OSHA-enforced regulations? a. "OSHA regulations apply to USDA, EPA and FDA workers also" b. "OSHA regulations assure the quality, safety, and efficacy of marketed drugs." c. Employers must report to OSHA if there are more than 3 people hospitalized due to a work-related incident. d. OSHA regulations apply to most private sector workers e. OSHA regulations do not apply to self-employed workers

b. "OSHA regulations assure the quality, safety, and efficacy of marketed drugs."

What does not apply to the 1953 Factory Inspections Amendment to the FDCA? a. FDA inspectors are to provide the factory with the results of analysis of samples the inspectors obtained b. "With the FIA, FDA inspectors are required to present a warrant prior to conducting inspections" c. "FIA required FDA inspectors to present a notice of inspection, or FDA Form-482" d. "Resulted from a Supreme Court lawsuit won by Cardiff, president of an association of dried fruit manufacturers" e.The amendment required inspectors to provide the manufacturer with a report of the observations made during the inspection

b. "With the FIA, FDA inspectors are required to present a warrant prior to conducting inspections

What is not true of OSHA requirements for safety training? a. "Can include training in proper handling of bloodborne pathogens, especially viruses" b. Includes communications on hazardous chemicals c. "Safety training is only required of newly hired, incoming personnel " d. Includes training on the need for and use of personal protective equipment (PPE) e. Safety training is not required of self-employed people

c. "Safety training is only required of newly hired, incoming personnel "

Audits tend to focus on records 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.Test results which are consistent when reported in different documents b. Accurate data entry c. Back dating of lab notebook entries d. Complete recording of data in batch records e. Recording deviations from the SOPs

c. Back dating of lab notebook entries

"Audits are periodic, data-based, assessments to verify a company's 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 manufacturer's QA group?" a. "Quality Control group, their laboratories and records" b. "Manufacturing group, the production suite and their records" c. FDA's Bioresearch Monitoring Office d. Contract manufacturing organizations e. Raw material suppliers

c. FDA's Bioresearch Monitoring Office

What is not included in workers rights under OSHA regulations? a. "Workers cannot be retaliated or discriminated and workers may file a complaint if punished or retaliated against for acting as a whistleblower, that is for reporting practices in the company that violate regulations" b. Workers may request to get or see copies of OSHA inspection results c. Workers can request payroll distribution statistics from management d. Workers can request OSHA to inspect work environment e. "Workers are to receive info and training about hazards, and methods to prevent harm from those hazards."

c. Workers can request payroll distribution statistics from management

"A typical audit of a company's quality system compliance takes 2-5 days, ends with a summary of observations, after which issues found are ____________________." a. swept under the rug until before the next audit date b. immediately sent to the nearest FDA office c. followed up to see what steps have been done to correct and prevent them d. hidden from regulators e. corrected by deleting them from documents

c. followed up to see what steps have been done to correct and prevent them

The FDA Ombudsman is involved in: a. drafting and passing food and drug laws b. performing analysis of drug samples obtained by FDA inspection teams c. resolving disputes between a drug manufacturer and FDA offices d. issuing warning letters to non-compliant drug manufacturers e. inspecting drug manufacturing facilities for compliance with regulations

c. resolving disputes between a drug manufacturer and FDA offices

Which workplace hazard is the OSH Act not designed to protect workers from? a. Caustic chemicals that can burn one's skin b. Loud equipment that can damage hearing c. Loss of limb from poorly designed equipment d. Co-workers who refuse to comply with cGMP e. The ergonomic hazards from repetitive movement and poor body positioning

d. Co-workers who refuse to comply with cGMP

"The FDA follows a six system inspection model to assess a company's compliance with cGMPs, where the quality system is always inspected. Which is not one of the remaining five systems?" a. Laboratory control system b. Production system c. Materials system d. Computer system e. Facilities and equipment system

d. Computer system

What is not correct about employer responsibility under OSHA regulations? a. Employers are required to prominently display the official OSHA Job Safety and Health Poster b. Conduct safety training in a language the workers can understand c. Provide required personal protective equipment (PPE) at no cost to workers d. Discourage workers from reporting safety issues directly to OSHA e. Report all in-patient hospitalization and deaths to OSHA

d. Discourage workers from reporting safety issues directly to OSHA

What is not true of FDA Form 483? a. Drug manufacturers are expected to respond to the 483 with their proposed corrective actions within 15 days after receipt of 483 b. Form 483 serves as a guide to the manufacturer for corrective actions c. Form 483 lists objectionable conditions or practices found by FDA inspectors d. FDA's form 483 is also known as "notice of inspectional observations" e. "Through a Form 483, all of a company's profits from the sale of violative products are disgorged"

e. "Through a Form 483, all of a company's profits from the sale of violative products are disgorged"

"_____________________is a secure electronic or computerized recording system where entries cannot be altered, or if they are altered, the history of the alterations can be tracked including who did it, why, and when." a. Secret lab b. Notice of inspection c. Laboratory automation d. Cloud computing e. Audit trail

e. Audit trail

What is not correct about FDA's directed type of inspections of drug manufacturers? a. Directed inspections include pre-approval inspections that are conducted after NDA filing and prior to NDA approval b. Directed inspections are sometimes conducted to follow up on earlier FDA observations c. Directed inspections may be conducted in response to violations reported to the FDA d. Directed inspections are conducted under FDA's bioresearch monitoring program e. Directed inspections are also known as surveillance inspections and conducted every two years

e. Directed inspections are also known as surveillance inspections and conducted every two years