QA and QC IJNIP

Quality

It is the totality features or conformance to specifications of a product

Specifications

A list of detailed requirements or standards (acceptance criteria for the prescribed test procedures)

D

Which of the following statements will correctly define the principle of total quality in the manufacture of pharmaceutical products?

a. Strict adherence to standards combines with quality

b. Use of state of the art equipment and advance technology

C. Production department is responsible for quality

d. Quality is everybody's business in a pharmaceutical establishment

Total quality management

It is the combined team effort to develop, produce, market, distribute, and control products that are safe and will be effective for the time they remain in the marketplace

ISO 9001

Boards: What is the standard in quality management system?

B

It is the Totality of The organized arrangements made with the objective of ensuring that pharmaceutical products are of the quality required for Their intended use.

a. CGMP

b. QA

c. QC

d. QRM

Quality control

The part of cGMP concerned with sampling, specifications and testing and the organization documentation, and release procedures.

Product Quality review

Regular periodic quality reviews of all registered drug products  to verify consistency of the existing process and to identify product and process improvements

C

Functions of Quality Control Unit include the following, EXCEPT:

a. inspection control

b. analytical control

c. audit

d. stock control

B

This important document specifies all the tests to be conducted on a material and the expected results:

a. MSDS

b. Monograph

c. COA

d. SOP

A

A handbook that described the various elements of the QMS for assuring the quality of the test result

A. Quality manual

B. MSDS.

C. SOP

D. COA

C

An authorized written procedure giving step by step instructions for performing operations, both general and specific

A. Quality manual

B. MSDS.

C. SOP

D. COA

D

Document containing the actual results of all tests conducted on a specific material or product to show compliance or noncompliance with established standards

A. Quality manual

B. MSDS.

C. SOP

D. COA

B

Contains information on the on the potential health effects of exposure to chemicals and on safe working procedures when handling chemical products

A. Quality manual

B. MSDS.

C. SOP

D. COA

P-plan

The most common sampling plan used in the pharmaceutical industry is:

Sampling

The process of selecting a certain portion of a product for the purpose of testing and inspection

D

Control chart limit which alerts the operator to closely monitor the process being done:

a. Acceptable limit

b. Upper control limit

c. Action limit

d. Warning limit

C

Control chart limit which alerts the operator to closely monitor the process being done:

a. Acceptable limit

b. Upper control limit

c. Action limit

d. Warning limit

A

A chart that measures the non-proportion defectives

A. Np chart

B. Xbar chart

C. P-chart

B

A Chart used for measurable characteristics; measured  by mean and standard deviation

A. Np chart

B. Xbar chart

C. P-chart

C

Control chart limit which alerts the operator to stop the process and do corrective actions:

a. Acceptable limit

b. Upper control limit

c. Action limit

d. Warning limit

C

The following statements about qualification are true, EXCEPT: va.

A part of validation

b. Is mainly for equipment and instruments

C. Used to challenge The performance of processes

d. None of the above

B

Occurs during actual use of process

A. Retrospective

B. Concurrent

C. Prospective

C

Occurs prior to implementation:Preferred

A. Retrospective

B. Concurrent

C. Prospective

A

Occurs after production use has occurred; based on review of historic effect.

A. Retrospective

B. Concurrent

C. Prospective

D

Samples of vials of Hydrocortisone Injection were found to be contaminated with Bacillus subtilis. How will you classify this type of product defect?

a. Minor defect

b. Variable defect

c. Ocular defect

d. Critical defect

Out of specification

Test result that fall outside the specifications

C

It is the type of product defects that may endanger the life of patient

A. Minor

B. Major

C. Critical

D. Variable

E. Attributive

B

It is the type of product defects that do not endanger the life of patient but affects the function of the product.

A. Minor

B. Major

C. Critical

D. Variable

E. Attributive

A

It is the type of the product defects that does not endanger life of patient nor does it affect the function of the product

A. Minor

B. Major

C. Critical

D. Variable

E. Attributive

D

It is the type of product defects that can be measured by instrument

A. Minor

B. Major

C. Critical

D. Variable

E. Attributive

E

It is the type of product defects that can be measured by inspection

A. Minor

B. Major

C. Critical

D. Variable

E. Attributive

D

Certain batches of allopurinol 300-mg tablets were found to have discoloration. Which Type of recall should be iniliated by the manufacturer?

a. No need for recall

b. Class I

c. Class II

d. Class III

C

May cause temporary / medically reversible adverse health consequences

a. No need for recall

b. Class I

c. Class II

d. Class III

B

It is a type of product recall that may cause death or serious adverse health consequences

a. No need for recall

b. Class I

c. Class II

d. Class III

C

The period of stability of a preparation is the time from the date of manufacture of the formulation until its biological or chemical activity is no less than how many percent of the labeled potency?

a. 80%

b. 85%

c. 90%

d. 95%

Stability

It is the capacity of a drug to remain within specification

D

Which of the following is TRUE regarding the decomposition and stabilization of drug products?

I. Hydrolysis, oxidation, and photolysis are the most common causes of drug decomposition.

II. The addition of alpha-tocopherol can prevent oxidation of fixed oils.

III. Hydrolysis may be prevented by preparing the drug into a dry powder for reconstitution.

a. I, Il

b. I, III

c. II, III

d. I, II, II

Arrhenius equation

Board exam: What is the equation use to estimate the shelf life?

C

What do you call to the period of time during which a product is expected to remain within specification?

A. Expiration date

B. Decomposition date

C. Shelf-life

D. Stability studies

A

What do you call to the time  or date prior to which a product is expected to remain stable and after which it must not be used

A. Expiration date

B. Decomposition date

C. Shelf-life

D. Stability studies

D

According to the ASEAN Guidelines for Stability Studies, The Philippines belongs to which climatic zone?

a. Zone III

b. Zone IVa

c. Zone I

d. Zone IVb

C

Accelerated stability Testing of pharmaceulical articles is carried out at:

D

It is used to estimate the shelf-life of a drug product

A. Expiration date

B. Decomposition date

C. Shelf-life

D. Stability studies

B

What is the base guidelines for stability studies?

a. PIC/S Guidelines

b. ASEAN guidelines on stability studies

c. Military Standard 105 E

d. Square Root System

C

Which of the following stability studies follow zero-order kinetic?

A. Stress testing

B. Accelerated studies

C. Long term/real time studies

B

Which of the following stability studies follow first-order kinetic?

A. Stress testing

B. Accelerated studies

C. Long term/real time studies

C

In accelerated studies, what is the extrapolated t90?

A. 3 years

B.5 years

C. 2 years

D.  1 year

A

To control raw materials in the warehouse of a company, which distribution practice assures that the stocks brought in first are used first?

a. FIFO

b. LIFO

c. LEFO

D. FEFO

D

The products whose expiration dates are approaching are moved out of the warehouse first

a. FIFO

b. LIFO

c. LEFO

D. FEFO