session 3 practice probelms

What does cGMP stand for?

 

Controlled Good Manufacturing Practice

 

Comprehensive Good Manufacturing Practice

 

Certified Good Manufacturing Practice

 

Current Good Manufacturing Practice

 

Common Good Manufacturing Practice

Current Good Manufacturing Practice

Which subpart of 21 CFR 211 covers the requirements for the organization and personnel involved in manufacturing?

 

Subpart A

 

Subpart D

 

Subpart E

 

Subpart B

 

Subpart C

Subpart B

What is the primary focus of the Quality Control Unit as defined in cGMP regulations?

 

Designing the product packaging

 

Accepting or rejecting anything related to the product

 

Conducting clinical trials

 

Managing the company's finances

 

Marketing and sales of the product

Accepting or rejecting anything related to the product

According to cGMP, what is one of the consequences of noncompliance during an FDA inspection?

 

Order to recall and remove product from market

 

Immediate market approval

 

Marketing incentives

 

Stock market boost

 

Increased production quotas

Order to recall and remove product from market

What is the purpose of Current Good Manufacturing Practices (cGMP)?

 

To establish requirements for drug marketing and sales

 

To define the legal framework for pharmaceutical patent applications

 

To ensure that pharmaceutical products are produced consistently and controlled according to quality standards

 

To set standards for the financial operations of pharmaceutical companies

 

To create guidelines for medical research protocols

To ensure that pharmaceutical products are produced consistently and controlled according to quality standards

The definition of a 'Drug Product' is included in 21 CFR 211 Subpart:

 

A

 

B

 

C

 

D

A

According to cGMP Regulations – 21 CFR 211, an inactive ingredient is:

 

any ingredient intended for use in the manufacture of a drug product, including those that may not be in finished product – for example - solvent.

 

any ingredient intended for use in the manufacture of an active pharmaceutical ingredient, including those that may not be in finished product – for example - solvent.

 

any component other than the active ingredients in a drug product.

 

any component other than the active ingredients and excipients in a drug product.

any component other than the active ingredients in a drug product

The documented evidence that demonstrates a system does what is claims is called:

 

Master record

 

Compliance

 

Validation

 

Verified

Validation

In GMP, all records must be reviewed and approved by the:

 

Quality officer

 

Quality Assurance unit

 

Quality Control unit

 

FDA

Quality Control unit

USP and NF are regulations.

 

True

 

False

False

A child resistant container is one that is significantly difficult for children under ___years of age to open or to obtain a ______ amount of its contents within a reasonable amount of ________ while not being difficult for ‘normal adults’ to use

5; harmful; time

Each of the following materials may be considered components according to CGMP definition:

 

Glycerin used as a co-solvent

 

Ethanol evaporated before making a tablet

 

Sucrose used in preparing syrups

 

All of above

All of above

A foreign facility manufactures a drug product that will be supplied to the United States. Which statement is correct?

A. cGMP applies only after the product reaches a U.S. distributor

B. cGMP applies only to manufacturers physically located in the United States

C. cGMP requirements apply to the foreign supplier and manufacturer

D. cGMP does not apply if the product has already been approved

cGMP requirements apply to the foreign supplier and manufacturer

A company collects documented evidence that its sterilization process consistently performs as intended. What is this activity called?

A. Verification

B. Process validation

C. Quality audit

D. Certification

Process validation

A raw-material lot fails its acceptance specifications, but the production department wants to use it to avoid a delay. Who has authority to reject the lot?

A. The Quality Control Unit

B. The marketing department

C. The distribution department

D. The equipment supplier

The Quality Control Unit

During storage, part of a drug moves from the product into or onto its plastic container, lowering the drug concentration. Which packaging problem occurred?

A. Leaching

B. Permeability

C. Sorption

D. Light transmission

Sorption