[MANUFACTURING PHARMACY] Introduction - Part 1

a. Primary

Manufacturing activity:

Manufacturing of API and excipients (raw materials)

a. Primary

b. Secondary

c. Tertiary

d. Toll manufacturing

a. Primary

Manufacturing activity:

Chemist are more involved than RPh.

a. Primary

b. Secondary

c. Tertiary

d. Toll manufacturing

b. Secondary

Manufacturing activity:

Manufacturing of drug product; RPh is more involved.

a. Primary

b. Secondary

c. Tertiary

d. Toll manufacturing

c. Tertiary

Manufacturing activity:

Packaging, labeling, repacking of bulk finished product.

Imported products

a. Primary

b. Secondary

c. Tertiary

d. Toll manufacturing

d. Toll manufacturing

Manufacturing activity:

Subcontract arrangement

They accept product of theirs that is not owned by them but is owned by the Marketing Authorization Holder (MAH)

a. Primary

b. Secondary

c. Tertiary

d. Toll manufacturing

a. Research and Development

Department of manufacturing company:

1) Formulate the new product

2) Improve the existing products

3) Clinical trials/other

4) Researches or Drug Discovery

a. Research and Development

b. Production

c. Quality Assurance (QA)

d. Quality Control (QC)

b. Production

Department of manufacturing company:

1) All activities involved in the manufacturing

2) From dispensing, compounding up to packaging

3) Heart of Manufacturing

4) Include storage and warehousing

a. Research and Development

b. Production

c. Quality Assurance (QA)

d. Quality Control (QC)

b. Production

Largest and deals with all the stages of manufacturing batches of finished drug products.

a. Research and Development

b. Production

c. Quality Assurance (QA)

d. Quality Control (QC)

b. Production

Plans production according to manufacturing order and accomplishes the BMR.

a. Research and Development

b. Production

c. Quality Assurance (QA)

d. Quality Control (QC)

b. Production

Heart of manufacturing:

a. Research and Development

b. Production

c. Quality Assurance (QA)

d. Quality Control (QC)

a. True

Warehouse is now more preferred to as storage area.

a. True

b. False

c. Quality Assurance (QA)

Department of manufacturing company:

1) Assure that all operation for the product meet the standard of safety and efficacy

2) Ensures that everyone follows/complies to the Good Manufacturing Practice (GMP)

a. Research and Development

b. Production

c. Quality Assurance (QA)

d. Quality Control (QC)

c. Quality Assurance (QA)

Department of manufacturing company:

1) Conducts the quality audit and monitoring of audit

2) Prepares the different SOPs or is responsible for the final approval of the SOPs

3) Cooperate with the regulatory agencies

a. Research and Development

b. Production

c. Quality Assurance (QA)

d. Quality Control (QC)

d. Quality Control (QC)

Department of manufacturing company:

1) Under QA

2) Conducts the test sampling whether it's inprocess test or test for approval of usage of raw materials

3) Documentation of the raw materials & their assay results

a. Research and Development

b. Production

c. Quality Assurance (QA)

d. Quality Control (QC)

d. Quality Control (QC)

Department of manufacturing company:

Performs IPQC and environmental testing.

a. Research and Development

b. Production

c. Quality Assurance (QA)

d. Quality Control (QC)

e. Warehouse

Department of manufacturing company:

1) Stores materials and finished products

2) Holds incoming components in the quarantine area

3) Involved in purchasing and logistics

a. Research and Development

b. Production

c. Quality Assurance (QA)

d. Quality Control (QC)

e. Warehouse

a. Marketing

Department of manufacturing company:

1) Study the current trends (demand & supply of consumer behavior, product status in the market)

2) Responsible for the product promotion & advertising

a. Marketing

b. Regulatory affairs

c. Engineering

d. Medical

b. Regulatory affairs

Department of manufacturing company:

Ensures the compliance to the rules and regulations that are mandates by the regulatory authorities such as in licensing.

a. Marketing

b. Regulatory affairs

c. Engineering

d. Medical

a. Samuel Zacate

FDA Director-General.

a. Samuel Zacate

b. Ted Herbosa

b. Ted Herbosa

DOH Secretary.

a. Samuel Zacate

b. Ted Herbosa

c. Engineering

Department of manufacturing company:

1) Installation

2) Maintenance and repair of the equipment or apparatus within the manufacturing premises

a. Marketing

b. Regulatory affairs

c. Engineering

d. Medical

a. Validation

Action of proving and documenting that any process, procedure or method actually and consistently leads to the expected results.

a. Validation

b. Qualification

b. Qualification

Action of proving that premises, systems or equipment work correctly and actually lead to expected results

a. Validation

b. Qualification

d. Medical

Department of manufacturing company:

1) In-house clinic

2) Physical exam of the employees

3) Help R&D in performing clinical trials

a. Marketing

b. Regulatory affairs

c. Engineering

d. Medical

a. Batch

Specific quantity of the product in a single cycle of manufacturing

a. Batch

b. Lot

c. Batch number/lot number

d. Master formula

e. Batch Manufacturing Record (BMR) / Master Batch Record

b. Lot

Part of the batch

a. Batch

b. Lot

c. Batch number/lot number

d. Master formula

e. Batch Manufacturing Record (BMR) / Master Batch Record

c. Batch number/lot number

Easy identification & traceability most applicable in Recall

a. Batch

b. Lot

c. Batch number/lot number

d. Master formula

e. Batch Manufacturing Record (BMR) / Master Batch Record

d. Master formula

Contains the formulation, specifications, procedures, QA as well as labeling requirements.

a. Batch

b. Lot

c. Batch number/lot number

d. Master formula

e. Batch Manufacturing Record (BMR) / Master Batch Record

e. Batch Manufacturing Record (BMR) / Master Batch Record

Ensures consistency of manufacturing procedures & if all procedures in QC test are completed

Checklist such as time it was done, who did it & etc.

a. Batch

b. Lot

c. Batch number/lot number

d. Master formula

e. Batch Manufacturing Record (BMR) / Master Batch Record

a. Master Batch Record

Parameter: mixing time, speed

a. Master Batch Record

b. Standard Operating Procedures (SOPs)

c. Manufacturing order

d. Overage

e. Quarantine

f. Validation

b. Standard Operating Procedures (SOPs)

Step-by-step instructions

a. Master Batch Record

b. Standard Operating Procedures (SOPs)

c. Manufacturing order

d. Overage

e. Quarantine

f. Validation

c. Manufacturing order

Instructions given to the Production department to produce a specific product

a. Master Batch Record

b. Standard Operating Procedures (SOPs)

c. Manufacturing order

d. Overage

e. Quarantine

f. Validation

d. Overage

Addition of API in an unstable preparation to compensate of loss during manufacturing process.

a. Master Batch Record

b. Standard Operating Procedures (SOPs)

c. Manufacturing order

d. Overage

e. Quarantine

f. Validation

E. Quarantine

Awaiting for the result if the product is approved or rejected.

a. Master Batch Record

b. Standard Operating Procedures (SOPs)

c. Manufacturing order

d. Overage

e. Quarantine

f. Validation

a. Yellow

Status: Quarantine

a. Yellow

b. Green

c. Red

b. Green

Status: Approved

a. Yellow

b. Green

c. Red

c. Red

Status: Reject

a. Yellow

b. Green

c. Red

F

1) Documented evidence that a system does what it is supposed to do.

2) If all procedures in the system has a consistent result.

a. Master Batch Record

b. Standard Operating Procedures (SOPs)

c. Manufacturing order

d. Overage

e. Quarantine

f. Validation

d. None

Significance of packaging except:

a. Identification of the product

b. Part of protection (to protect the product inside)

c. Aid in preparing because of the label

d. None

a. Primary or immediate packaging

Type of packaging:

Direct contact with the product.

a. Primary or immediate packaging

b. Secondary packaging

c. Tertiary packaging

b. Secondary packaging

Type of packaging:

Protect the primary packaging

a. Primary or immediate packaging

b. Secondary packaging

c. Tertiary packaging

c. Tertiary packaging

Type of packaging:

Bulk packaging

a. Primary or immediate packaging

b. Secondary packaging

c. Tertiary packaging

a. Primary or immediate packaging

Type of packaging:

Bottles, prefilled syringes caps, liners

a. Primary or immediate packaging

b. Secondary packaging

c. Tertiary packaging

b. Secondary packaging

Type of packaging:

Unit carton, product information leaflet (PIL)

a. Primary or immediate packaging

b. Secondary packaging

c. Tertiary packaging

c. Tertiary packaging

Type of packaging:

Boxes

a. Primary or immediate packaging

b. Secondary packaging

c. Tertiary packaging

a. Well-closed

Classification of container:

Protection against solids & to not let the product spill or fall down but there can be an entry of vapor.

a. Well-closed

b. Tight

c. Hermetic

d. Light resistant

e. Child resistant

f. Tamper resistant

b. Tight

Classification of container:

Protected against solids, liquids % some vapors.

a. Well-closed

b. Tight

c. Hermetic

d. Light resistant

e. Child resistant

f. Tamper resistant

c. Hermetic

Classification of container:

Protection against air and other gases.

a. Well-closed

b. Tight

c. Hermetic

d. Light resistant

e. Child resistant

f. Tamper resistant

c. Hermetic

Ampoules

a. Well-closed

b. Tight

c. Hermetic

d. Light resistant

e. Child resistant

f. Tamper resistant

d. Light resistant

Classification of container:

Protection from light e.g., amber bottles.

a. Well-closed

b. Tight

c. Hermetic

d. Light resistant

e. Child resistant

f. Tamper resistant

e. Child resistant

Classification of container:

Needs push and twist mechanism to open so it won't be easier for children 5 years old and below to open it.

a. Well-closed

b. Tight

c. Hermetic

d. Light resistant

e. Child resistant

f. Tamper resistant

b. False

Child resistant container is intended to not opened by children 10 years old and below.

a. True

b. False

f. Tamper resistant

Classification of container:

It's obvious if it's opened/used for there's an indicator of breaching or any missing.

a. Well-closed

b. Tight

c. Hermetic

d. Light resistant

e. Child resistant

f. Tamper resistant

f. Tamper resistant

Tape seal, bottle seal, shrink seal

a. Well-closed

b. Tight

c. Hermetic

d. Light resistant

e. Child resistant

f. Tamper resistant

a. Single unit or Unit dose

One time use.

a. Single unit or Unit dose

b. Multiple unit of Multiple dose

b. Multiple unit of Multiple dose

Needs to have antimicrobial agent to protect integrity of product because it is multiple use.

a. Single unit or Unit dose

b. Multiple unit of Multiple dose

a. Single unit or Unit dose

No antimicrobial agent or preservative is needed.

a. Single unit or Unit dose

b. Multiple unit of Multiple dose

b. Multiple unit of Multiple dose

USP limit volume is 30 mL.

a. Single unit or Unit dose

b. Multiple unit of Multiple dose

b. 30 mL

USP limit for volume of multiple dose.

a. 20 mL

b. 30 mL

c. 100 mL

d. 1000 mL

a. Single unit or Unit dose

Cannot be resealed.

a. Single unit or Unit dose

b. Multiple unit of Multiple dose

b. Multiple unit of Multiple dose

BWFI, Vials

a. Single unit or Unit dose

b. Multiple unit of Multiple dose

a. Single unit or Unit dose

USP limit is 1000 mL (some of LVPs)

a. Single unit or Unit dose

b. Multiple unit of Multiple dose

a. Single unit or Unit dose

WFI

SWFI

Ampoules

Pre-filled syringes

a. Single unit or Unit dose

b. Multiple unit of Multiple dose

d. 1000 mL

USP limit for volume of single unit dose.

a. 20 mL

b. 30 mL

c. 100 mL

d. 1000 mL

c. IV, V

Single unit except:

I. WFI

II. SWFI

III. Ampoules

IV. Vials

V. BWFI

VI. Pre-filled syringes

a. I, II, V

b. III, IV

c. IV, V

d. IV, V, VI

c. Silicon dioxide (SiO2)

Main component of glass.

a. Calcium tetraborate

b. Boric acid

c. Silicon dioxide (SiO2)

d. Silicon oxide (SiO)

e. Calcium hydroxide

d. Infragility

Advantages of glass except:

a. Strength

b. Inertness feels

c. Barrier protection

d. Infragility

e. None

c. Not strong

Disadvantages of glass except:

a. Fragile

b. Relatively heavier

c. Not strong

d. None

b. False

Common instability of glass is leaching which is transfer of constituents from product to container.

a. True

b. False

a. True

Common instability of glass is leaching which is transfer of constituents from container to product.

a. True

b. False

a. Glass Type I

Type of glass:

1) Highly resistant borosilicate glass

2) Contains boric oxide

3) Most resistant to heat, chemicals, and leaching

a. Glass Type I

b. Glass Type II

c. Glass Type III

d. NP (Non-parenteral)

c. Boric oxide

Glass Type I contains

a. Boric dioxide

b. Calcium hydroxide

c. Boric oxide

d. Calcium oxide

a. Glass Type I

Type of glass:

1) For buffered or non-buffered aqueous parenterals

2) Preferred for laboratory use

a. Glass Type I

b. Glass Type II

c. Glass Type III

d. NP (Non-parenteral)

b. Glass Type II

Type of glass:

1) Treated soda-lime glass

2) Surface is treated with Sulfur dioxide (SO2), making the surface dealkalized

a. Glass Type I

b. Glass Type II

c. Glass Type III

d. NP (Non-parenteral)

b. Glass Type II

Type of glass:

For buffered aqueous acidic parenterals.

a. Glass Type I

b. Glass Type II

c. Glass Type III

d. NP (Non-parenteral)

b. False

Glass Type II is for buffered aqueous basic parenterals.

a. True

b. False

c. Glass Type III

Type of glass:

1) Soda-lime glass

2) Less resistant to high temperature

a. Glass Type I

b. Glass Type II

c. Glass Type III

d. NP (Non-parenteral)

c. Glass Type III

Type of glass:

For dry solid for reconstitution, oily solutions

a. Glass Type I

b. Glass Type II

c. Glass Type III

d. NP (Non-parenteral)

d. NP (Non-parenteral)

Type of glass:

1) General purpose soda-lime glass

2) Least resistant to leaching, chemical attacks and heat shock

a. Glass Type I

b. Glass Type II

c. Glass Type III

d. NP (Non-parenteral)

d. NP (Non-parenteral)

Type of glass:

Not for parenteral

a. Glass Type I

b. Glass Type II

c. Glass Type III

d. NP (Non-parenteral)

d. a and b

Advantages of polymers:

a. Light to carry

b. Durable

c. Inertness feel

d. a and b

e. a and c

f. all

f. All

Disadvantages of polymers:

a. Permeability problem (in-and-out of gases)

b. Leaching

c. Environmental concern

d. a and b

e. b and c

f. All

a. True

Leaching is more prominent in plastics than glass.

a. True

b. False

a. True

One way to prevent leaching in plastics is by putting a lining.

a. True

b. False

b. Thermosets

Permanently hard.

a. Thermoplastics

b. Thermosets

a. Thermoplastics

Soft when heated, once cool harden afterwards.

a. Thermoplastics

b. Thermosets

a. High Density Polyethylene (HDPE)

Type of polymer:

Hard thermosets

a. High Density Polyethylene (HDPE)

b. Low Density Polyethylene (LDPE)

c. Polypropylene (PP)

d. Polyethylene terephthalate (PET)

e. Polyvinylchloride (PVC)

a. High Density Polyethylene (HDPE)

Type of polymer:

Usually for solid dosage forms

a. High Density Polyethylene (HDPE)

b. Low Density Polyethylene (LDPE)

c. Polypropylene (PP)

d. Polyethylene terephthalate (PET)

e. Polyvinylchloride (PVC)

b. Low Density Polyethylene (LDPE)

Type of polymer:

Flexible and durable

a. High Density Polyethylene (HDPE)

b. Low Density Polyethylene (LDPE)

c. Polypropylene (PP)

d. Polyethylene terephthalate (PET)

e. Polyvinylchloride (PVC)

b. Low Density Polyethylene (LDPE)

Type of polymer:

1) Usually for medicine droppers

2) Applicators for ophthalmic and otic solutions

a. High Density Polyethylene (HDPE)

b. Low Density Polyethylene (LDPE)

c. Polypropylene (PP)

d. Polyethylene terephthalate (PET)

e. Polyvinylchloride (PVC)

c. Polypropylene (PP)

Type of polymer:

1) High temperature resistance

2) Can be autoclaved

a. High Density Polyethylene (HDPE)

b. Low Density Polyethylene (LDPE)

c. Polypropylene (PP)

d. Polyethylene terephthalate (PET)

e. Polyvinylchloride (PVC)

c. Polypropylene (PP)

Type of polymer:

Mixed with polyethylenes to make collapsible bags.

a. High Density Polyethylene (HDPE)

b. Low Density Polyethylene (LDPE)

c. Polypropylene (PP)

d. Polyethylene terephthalate (PET)

e. Polyvinylchloride (PVC)

d. Polyethylene terephthalate (PET)

Type of polymer:

1) Bottle for water and beverages

2) Not important pharmaceutically

a. High Density Polyethylene (HDPE)

b. Low Density Polyethylene (LDPE)

c. Polypropylene (PP)

d. Polyethylene terephthalate (PET)

e. Polyvinylchloride (PVC)

b. False

Polyethylene terephthalate (PET) is the most pharmaceutically important plastic polymer.

a. True

b. False

e. Polyvinylchloride (PVC)

Type of polymer:

Least resistant to permeation.

a. High Density Polyethylene (HDPE)

b. Low Density Polyethylene (LDPE)

c. Polypropylene (PP)

d. Polyethylene terephthalate (PET)

e. Polyvinylchloride (PVC)

e. Polyvinylchloride (PVC)

Type of polymer:

Used in blister packs and collapsible bags

a. High Density Polyethylene (HDPE)

b. Low Density Polyethylene (LDPE)

c. Polypropylene (PP)

d. Polyethylene terephthalate (PET)

e. Polyvinylchloride (PVC)

d. I, II, III, IV

Composition of polyolefin.

I. LDPE

II. HDPE

III. PP

IV. Ethylene Vinyl Acetate (EVA)

a. I, II

b. I, II, III

c. II, III, IV

d. I, II, III, IV

b. False

Polyolefin is used for collapsible tube in replacement for flexible PVC.

a. True

b. False

a. True

Polyolefin is used for collapsible tube befor flexible PVC.

a. True

b. False

a. Polyethylene Terephthalate

Polymer No. 1

a. Polyethylene Terephthalate

b. High-density Polyethylene

c. Polyvinyl Chloride

d. Low-density Polyethylene

e. Polypropylene