Manufacturing Pharmacy -[Practice Question 1]

Proverbs 16:3

C) Lot

A specific identified portion of a batch
A) Batch Size
B) Batch Quantity
C) Lot
D) Lot Number
E) NOTA

D) A&B

• Research Department

• Parent Company

Personnel that are in charge of the preparation of the master formula.
A) Research Department
B) Parent Company
C) QA Department
D) A&B
E) NOTA

A) Dispensing Section

Area where raw materials for use in the production are weighed and/or measured.
A) Dispensing Section
B) Raw Material Section
C) In-Process
D) Production
E) NOTA

A) Rejected

Materials that are found to be substandard
A) Rejected
B) Approved for Use
C) Quarantined
D) Bulk
E) NOTA

B) Planning and Scheduling

Coordinates with the marketing department on what products are required for supply
A) Purchasing
B) Planning and Scheduling
C) Inventory
D) Warehouse
E) NOTA

A) SOP

This is a step-by-step method on how to go about a job
A) SOP
B) cGMP
C) Job order
D) Chart
E) NOTA

A) Certificate of Analysis

Document with the results of all tests conducted on material to show compliance or non-compliance with the standard specifications.
A) Certificate of Analysis
B) Master Formula
C) Manufacturing Order
D) Monograph
E) NOTA

B) Drug Trader

Registered owner of the drug product but subcontracts toll manufacture of such products to a licensed manufacturer.
A) Toll manufacturer
B) Drug Trader
C) Wholesaler
D) Distributor
E) NOTA

A) Wholesaler

Procures raw materials, AI, and or finished product from local establishment.
A) Wholesaler
B) Exporter
C) Importer
D) Retailer
E) NOTA

C) Manufacturing

The complete set of activities to produce a drug that comprise production and quality control from dispensing of materials to the release for distribution of the finished product.
A) Quality Assurance
B) Product Development
C) Manufacturing
D) Quality
E) NOTA

D) Price

The master formula consists of the following information, except:
A) Name of the product
B) Potency of the AI
C) Amount yield
D) Price
E) NOTA

B) QC head

In charged personnel for the preparation of the master formula if the master formula is not the actual amount to be manufactured.
A) QC staff
B) QC head
C) QA manager
D) RPh
E) NOTA

A) QC staff

In charged personnel that perform in-process tests while the product is compounded.
A) QC staff
B) QC head
C) QA manager
D) RPh
E) NOTA

D) Packaging

Section that is in charged with transferring the bottled, stripped, or packed products to the in-process area of the warehouse.
A) Production
B) Dispensing
C) Warehouse
D) Packaging
E) NOTA

C) US FDA

cGMP were first promulgated by the _____ in 1963 and finalized in 1979.
A) EU PIC
B) ASEAN Directive
C) US FDA
D) PIC/S
E) NOTA

D) Quality

Refers to the perception of the degree to which the product or service meets the customer’s expectation.
A) Quality Assurance
B) Product Development
C) Manufacturing
D) Quality
E) NOTA

D) cGMP

Part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.
A) Quality Assurance
B) PQS
C) Quality
D) cGMP
E) NOTA

A) Quality Assurance

The total of the organized arrangements made with the object of ensuring that medicinal products are of the quality for their intended use.
A) Quality Assurance
B) PQS
C) Quality
D) cGMP
E) NOTA

A) Quality Assurance

It is a wide-ranging concept which covers all matter which individually or collectively influence the quality of a product
A) Quality Assurance
B) PQS
C) Quality
D) cGMP
E) NOTA

A) Critical

_____- steps of manufacturing process and significant changes to the process validated
A) Critical
B) Minor
C) Simple
D) Secondary
E) NOTA

C) Man (Operators)

______ - are trained to carry out procedures correctly.
A) Machine
B) Material
C) Man
D) Method
E) NOTA

E) NOTA

Importance of the provisions of cGMP, except:
A) Prevents substandard, contaminated, or adulterated products.
B) Reduces batch-to-batch variation through standardized procedures.
C) Minimizes cross-contamination and labeling errors.
D) Allows tracing of errors, deviations, or product recalls when needed.
E) NOTA

A) Packaging

An economical means of providing presentation, protection, preservation, identification, information, containment, convenience, and compliance for a drug product
A) Packaging
B) Excipient
C) Final Adjuvant
D) Colorant
E) NOTA

B) PP (Polypropylene)

Plastic that is autoclavable
A) PVC
B) PP
C) PET
D) PE
E) NOTA

C) PET (Polyethylene terephthalate)

Plastic for beverages, have transparency and luster, can undergo gamma radiation.
A) PVC
B) PP
C) PET
D) PE
E) NOTA

A) PVC (Polyvinyl chloride)

Used for blister packaging.
A) PVC
B) PP
C) PET
D) PE
E) NOTA

D) Lightweight

The following are disadvantage of plastic, except:
A) Permeability
B) Leaching
C) Sorption
D) Lightweight
E) NOTA

D) General precautionary statements, such as “Protect from light” and or “Store in a dry place”, may be included, and should be used to conceal stability problems.

The following recommendations as to storage conditions can be prominently indicated on the label of the product, except:
A) The use of terms such as “ambient conditions” or “room temperature” is acceptable.
B) Where applicable specific requirements should be stated particularly for drug products that cannot tolerate freezing.
C) Recommendations should also be made as to the utilization period and storage conditions after opening and dilution or reconstitution of a solution
D) General precautionary statements, such as “Protect from light” and or “Store in a dry place”, may be included, and should be used to conceal stability problems.
E) NOTA

A) Stability

Capacity of drug to remain within specifications
A) Stability
B) Quality
C) Shelf-life
D) Sterilization
E) NOTA

B) Accelerated Stability studies

Assess the product’s stability under elevated stress conditions to predict its shelf life more quickly.
A) Real-time Stability Studies
B) Accelerated Stability studies
C) Forced Degradation Studies
D) Shelf-Life Extension Studies
E) NOTA