BTEC 3317 Quiz 12

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?

Storage areas of store pharmacies

Quality Control group, their laboratories and records

Contract manufacturing organizations

Manufacturing group, the production suite and their records

Storage areas of store pharmacies

3 multiple choice options

What does not apply to the 1953 Factory Inspections Amendment to the FDCA?

Resulted from a Supreme Court lawsuit won by Cardiff, president of an association of dried fruit manufacturers

FIA required FDA inspectors to present a notice of inspection, or FDA Form-482

With the FIA, FDA inspectors are required to present a judge-issued warrant prior to conducting inspections

FDA inspectors are to provide the factory with the results of analysis of samples the inspectors obtained

With the FIA, FDA inspectors are required to present a judge-issued warrant prior to conducting inspections

3 multiple choice options

What is not correct about FDA's directed type of inspections of drug manufacturers?

Directed inspections include pre-approval inspections that are conducted after NDA filing and prior to NDA approval

Directed inspections are routine inspections conducted every 2 years

Directed inspections may be conducted in response to violations reported to the FDA

Directed inspections are sometimes conducted to follow up on earlier FDA observations

Directed inspections are routine inspections conducted every 2 years

3 multiple choice options

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?

Safety system

Production system

Quality system

Facilities and equipment system

Safety system

3 multiple choice options

An FDA systems-based full inspection which is typically conducted for a new drug manufacturing company prior to its first drug approval involves:

Inspection of the quality system plus at least 5 other systems

Inspection of the quality system plus at least 3 other systems

Inspection of the quality system plus at least 2 other systems

Inspection of the quality system plus at least 1 other system

Inspection of the quality system plus at least 3 other systems

3 multiple choice options

_____________________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.

Notice of inspection

Audit trail

Cloud computing

Laboratory automation

Audit trail

3 multiple choice options

What is not true of FDA Form 483?

A Form 483 is presented by FDA inspectors to management upon arrival at the manufacturing site

Drug manufacturers are expected to respond to the 483 with their proposed corrective actions within 15 days after receipt of 483

Form 483 serves as a guide to the manufacturer for corrective actions

FDA's form 483 is also known as notice of inspectional observations

A Form 483 is presented by FDA inspectors to management upon arrival at the manufacturing site

3 multiple choice options

_________________ issued by the FDA, would allow FDA field staff to detain or hold without the need for physical inspection, products that potentially violated FDA laws and regulations, to prevent their distribution in the US.

Import alerts

Notifications

Form-483

Warning letters

Import alerts

3 multiple choice options

The FDA Ombudsman is involved in:

inspecting drug manufacturing facilities for compliance with regulations

performing analysis of drug samples obtained by FDA inspection teams

addressing issues drug manufacturers may have about certain FDA citations

issuing warning letters to non-compliant drug manufacturers

addressing issues drug manufacturers may have about certain FDA citations

3 multiple choice options

Which workplace hazard is the OSH Act not designed to protect workers from?

Compensation below the cost of living

Blood-borned pathogens

Caustic chemicals

Loss of limb from poorly designed equipment

Compensation below the cost of living

3 multiple choice options

What does not apply to OSHA and OSHA-enforced regulations?

Main goal in drug manufacturing is to minimize risks to drug product quality

OSHA stands for Occupational Safety and Health Administration, a federal agency under the Department of Labor

OSHA regulations do not apply to self-employed workers

OSHA regulations apply to most private sector workers

Main goal in drug manufacturing is to minimize risks to drug product quality

3 multiple choice options

What is true about employer responsibilities under OSHA regulations?

Employers should conduct safety training in a language the workers can understand

Employers should discourage workers from reporting safety issues to OSHA

Employers should provide personnel protective equipment to workers at fair market prices

Employers should not allow workers to see OSHA inspection results since those are confidential

Employers should conduct safety training in a language the workers can understand

3 multiple choice options

What is true of OSHA requirements for safety training?

Safety training is not required of temporary contractual workers

Proper use of personal protective equipment (PPE) is not included as part of safety training

Safety training is required of self-employed people

Safety training includes communications on hazardous chemicals

Safety training includes communications on hazardous chemicals

3 multiple choice options

OSHA regulations require that all work-related fatalities be reported to OSHA within 24hrs.

TRUE

FALSE

FALSE

1 multiple choice option

Certain biotechnology workers handle human blood that could potentially harbor bloodborne pathogens. What applies to OSHA standards for worker exposure to bloodborne pathogens?

HIV or Hepatitis B contaminated materials and lab coats can be disposed of in regular garbage bins

Workers not trained on bloodborne pathogen handling are free to enter laboratories where bloodborne pathogens maybe present

It is unacceptable to store food and drinking water in work areas with possible bloodborne pathogens

If workers are trained on chemical safety, they do not need to be trained on bloodborne pathogen work practices

It is unacceptable to store food and drinking water in work areas with possible bloodborne pathogens

3 multiple choice options