BTEC reg envt final exam

What is not true of regulations concerning the control of the quality of components, containers, and closures?

Procedures on the sampling, testing and approval of components, containers, and closures should be verbally communicated all the time

True:

written procedures on RISH STARR- receipt, id, storage, handling, sampling, testing, approval, release/rejection

quarantine and inspect until release

prevent contam

store off floor

inspected for correctness of labels, contents, container damage or broken seals, and contamination.

What property of containers and closures will not preserve the quality of drug products?

Containers and closures should leach chemicals into the drug product

true

not reactive, additive, or absorptive

not allow loss of drug substance to the outside

not allow the entry of contaminants from the outside

minimally reactive with the drug product

clean and sterilized -> remove pyrogens

For the sampling of components, containers, and closures, there should be a written protocol that needs to be followed. What is not compliant with cGMPs for the sampling procedures and tests

The passing criteria for samples should be changed if samples fail to conform to the criteria

STAAR

Compliant:

labelled, dated, and personnel who did the sampling must sign

at least 1 test of conformity to specifications as to quality and identity

avoid contamination

sampled beginning middle end

Content uniformity

Which critical quality attribute of tablet measures the tablet-to-tablet variability in the amounts of API per tablet?

Bioburden

The microbial counts on raw materials, in-process materials, drug components, containers or closures, is referred to as:

Many production SOPs have time limitations on the performance of a process. What would not be a cGMP-related reason as to the need for time limitation?

Prolonged process can lead to workers missing meals

reasons

Prolonged drying can lead to degradation of an API

Prolonged holding of a raw material can increase risks of microbial contamination

Insufficient mixing may lead to failed content uniformity in tablets

Insufficient drying can lead to unacceptable moisture levels in tablets

The expiration dates found on labels of drug products are based mainly on:

Results of stability tests

depends on storage conditions

cGMP regulations on laboratory controls require that the accuracy, sensitivity, specificity, and reproducibility of methods used to test raw and in-process materials and drug products, be established and documented. What is a correct description of the required parameters for cGMP-compliant test methods?

Reproducibility is the ability of a test method to give the same results when samples are performed by different analysts.

accuracy, sensitivity, specificity, and reproducibility of methods established and documented

specificity- ability to tell that a chemical one is interested in quantifying is what it's supposed to be and not a different chemical

Sensitivity-ability of a test method to detect the presence of a certain impurity that may be present at low levels in the drug product

What is not true of cGMP regulations concerning laboratory records?

Data from failed test results should not be recorded in laboratory notebooks

true

records retained for at least 1 year after the batch expo, 3 years after distribution

readily available at site where activities occurred, or available electronically

includes

methods used, weights and measures, graphs, charts, and calculations

complete data from all tests done

signt of researchers and second person who did accuracy review

deviations from sop and justifications

What information would be found in an executed batch record but not in the master batch record?

Deviations from the original manufacturing instructions

master batch- execution based on small scale, manftr & control instructions, theoretical, insures batch uniformity

executed batch- execution process, steps followed and deviations, actual numbers, results

What is a general requirement for prescription drug labelling?

Prescription drug labels should not be promotion

summary for safe and effective use, informative and accurate, not false/misleading, no implied claims

In the drug interaction section of drug labels, there could be a warning to avoid eating grapefruit when taking a drug. In what way does grapefruit affect the safe and effective use of a drug?

Grapefruit can lead to either an increase or decrease in the amount of API in the target tissues

grapefruit blocks thinks

_______________________ is an FDA-ran website that provides high quality information about marketed drugs and includes information found on drug package inserts.

DailyMed

What is the fair balance requirement?

An FDA advertising rule mandating that the negative effects and advantages of a medication be equally apparent to both consumers and physicians.

What is not a violation of FDA's regulations on drug promotion and advertising?

Ad lacks a statement encouraging the patient to report negative side effects to the Better Business Bureau.

violations

false/misleading info, readibility of info, misleading packaging, off label promotion, fair balance of effects

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?

Department of Health Laboratories that perform drug product testing

periodic, data-based, assessments to verify a companys compliance with regulations and guidelines -> QA unit or independent contractor, fed ad

Audited: QC. manufacturing, warehouse, suppliers, clinical sites, contract labs

What is not correct about FDAs directed type of inspections of drug manufacturers?

Directed inspections examine two or less of the systems in CDER's six-system model

correct

pre-approval inspections conducted after NDA filing and prior to NDA approval

concluded under FDAs biosearch monitoring program

in response to reported violatons

re-inspection to follow up

inspections are unlike surveillance inspections which are intended to be conducted every 2 years

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?

design system

full inspection- QS + 3, abv- QS + 2

systems:

materials

production

facilities and equipment

packaging and labeling

laboratory control

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 3 other systems

conducted for a new drug manufacturing company prior to its first drug approval

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?

Avoid recording deviations from SOPs

compliant- SOP followed, record deviations, effected drug quality, accurate, complete & consistent

Audit trail

____________ 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.

What is not true of FDA Form 483? Notice of inspectional obsos

Drug manufacturers are expected to respond to the FDA with their proposed corrective actions within 30 days after receipt of 438

true

guide for corrective actions

not to derive company of profits

lists objectionable conditions

FDA warning letter, response w in 15 days

Consent Decree

When a company fails to follow cGMP regulations and implement appropriate corrective actions after repeated warning letters, FDA subjects the company to an agreement whereby all profits made by the company from the sale of violative drug products are disgorged. This agreement is referred to as:

Import alerts 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.

TRUE

The main purpose of audits is to:

guide the continuous improvement of a drug manufacturer

Occupational Safety and Health Administration (OSHA) is an agency under the US Department of Labor. What is true of OSHA and OSHA-enforced regulations?

OSHA regulations main goal in drug manufacturing is to assure the safety of workers

Recognized hazards- noise, mech, chemicals, temp, unsanitary

private sector workers

state osha

not self employed

What is not true about workers rights under OSHA regulations?

Workers can request payroll distribution statistics from management

true

inspect work envt

cannot be retaliated/discriminated

info and training

inspection results and med records

What is true of OSHA requirements for safety training?

Safety training includes training on the need for and use of personal protective equipment (PPE)

language they can understand

blood borne. pathogens

hazard communications

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

In work areas with possible bloodborne pathogens, it is not acceptable to be applying lip balm

exposure control, eng control, work practice control, ppe, Hep B and HIV, haz com, records

What does not apply to Safety Data Sheets (SDS)?

describe the procedures for synth of chemical

info on transport and disposal, reg info, toxicological info ab chemical, provided by manufacturter

What does not apply to medical devices:

Medical devices achieve their primary intended purposes through chemical action within the body

applies

use in the diagnosis, cure, mitigation, prevention or treatment of disease

Many marketed devices have not been proven to be safe and effective in human clinical trials.

exert effects locally, some dont contact patients

include diagnostic tests and instruments

no direct therapeutic effect

What is the center within the FDA that regulates medical devices to ensure that they are safe and effective to use?

Center for Device and Radiological Health

What crisis led to the passage of the Medical Device Regulation Act of 1976, a law that gave the FDA authority to regulate the safety and effectiveness of devices?

A birth control device that led to infections and abortions

Dalkon shield cotraceptive IUD, infection in uterus ect

Medical Device Regulation Act of 1976, a law that gave the FDA authority to regulate the safety and effectiveness of devices?

What does not apply to the premarket approval process?

Clinical trial sites are not routinely inspected by CDRH as a requirement for PMA approval

not SE or 510k -> non clinical tests, 90 day prior, clinical evidence, manufacturing section, site inspection (BIMO)

Which of these devices poses minimal health risks to patients and is least likely to be classified as a Class III device? Use FDA's product classification tool to find the answer. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm

snake bite suction kit

class 1- low risk, exempt 510k

class 2- med risk, ODE compliance

class 3- high risk, premarket, not SE class 2

An Investigational Device Exemption allows an unapproved device to be tested in human subjects. The IDE submitted to FDA is not expected to contain:

Clinical trial results

IDE- shipped lawfully for clinical trials

expected

Sponsors role and need to monitor study

Clinical study protocol

device design

investigators or trial sites

risk elim

eligibility

What does not apply to an approved IDE?

An approved IDE will allow the marketing of an unapproved device which is significantly superior to a already marketed device

applies

support of a 510k submission

to collect safety and effectiveness data

premarket approval application

humatiarian device exemption

approval of a device for the treatment or diagnosis of a rare disease even without effectiveness data.

Six months after CDRH accepts the filing of PMA application for a device, what type of letter will CDRH send the manufacturer if the application for mostly meets regulatory requirements except that the label information may need to be revised?

approvable letter

approval order- good

not approbable- sig info needed

denying approval- does not meet req

What is true about the Supreme Court case involving Riegel vs Medtronic?

The Supreme Court did not penalize the device maker, Medtronic, for the defective device

devices with PMA immune from lawsuit from state courts bc states cant go above FDA approval

can sue in fed

What does not apply to Quality systems regulations for medical devices?

QSR applies to development and manufacturing process for Class I devices

does not apply- class 1 dev, med device reseaech

applies

equivalent to cGMP for pharmaceuticals

QSRs are found in CFR21 Part 820

req Unique Device Identifier (UDI) and UPC in marketed devices to facilitate post-market surveillance

What is not a component of design controls?

Defining device decommissioning

components

defining deliverables for manu

intended use of the device

personel responsibility assignment

Evaluating conformance of finished design to user needs and intended use

Validation of device performance

human factors

Human factor

is a discipline that focuses on device design variables that can affect performance of individuals using the devices, whether the person is a health care practitioner or the patient.

CDRH follows a quality system inspection technique (QSIT) to assess a device manufacturers compliance with QSRs. Which is not one of the seven systems making up the QSIT?

Labelling controls

systems

Management

Design controls

Corrective and Preventive Actions

Production and process controls

Materials Control

Facility and Equipment Control

records/documents

Which statement applies about reporting of adverse events associated about the use of certain medical devices?

Reporting of adverse events concerning devices is voluntary for patients and caregivers

medwatch

required for manufacturers, importers, device user facilities

Advertising and promotion of approved medical devices normally do not require pre-clearance of the materials with the FDA. However, advertising of a device for a non-FDA approved use is illegal and is considered:

Misbranding