Pharmaceutical Manufacturing Flashcards by Marah Joy M. FLORES

Preparation, processing, packaging, repacking, labelling, changing of container, wrapping or label.

PHARMACEUTICAL MANUFACTURING

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manufacturing that involves the production of Active Pharmaceutical Ingredients (APIs) and excipients?

a) Primary Manufacturing
b) Secondary Manufacturing
c) Tertiary Manufacturing
d) Toll Manufacturing

a) Primary Manufacturing

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manufacturing that involves the production of finished dosage forms?

a) Primary Manufacturing
b) Secondary Manufacturing
c) Tertiary Manufacturing
d) Toll Manufacturing

b) Secondary Manufacturing

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manufacturing that involves packaging, repacking, and labeling of bulk finished products?

a) Primary Manufacturing
b) Secondary Manufacturing
c) Tertiary Manufacturing
d) Toll Manufacturing

c) Tertiary Manufacturing

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a toll manufacturing arrangement?

a) A manufacturing process that produces APIs and excipients.
b) A process where finished dosage forms are produced.
c) A packaging and labeling process for bulk finished products.
d) An arrangement where a competent company manufactures products for another company.

d) An arrangement where a competent company manufactures products for another company.

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Specific quantity of product produced during a single manufacturing process

Batch
Lot
Batch/ Lot Number

Batch

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Specific portion of batch

Batch
Lot
Batch/ Lot Number

Lot

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For identification and traceability of a single batch/ lot

Batch
Lot
Batch/ Lot Number

Batch/ Lot Number

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Contains formulation, manufacturing procedures,
specifications, QA requirements, and labeling of a finished
product Master Batch Record or Batch Manufacturing

Master Formula
Batch Manufacturing Record (BMR)
Standard Operating Procedures (SOPs)
Manufacturing Order

Master Formula

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Ensures that batches were properly made and QC tests were performed; also includes the actual yield

Master Formula
Batch Manufacturing Record (BMR)
Standard Operating Procedures (SOPs)
Manufacturing Order

Batch Manufacturing Record (BMR)

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Step-by-step instruction for performing an operational task or activity

Master Formula
Batch Manufacturing Record (BMR)
Standard Operating Procedures (SOPs)
Manufacturing Order

Standard Operating Procedures (SOPs)

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Give instructions to production department to produce product

Master Formula
Batch Manufacturing Record (BMR)
Standard Operating Procedures (SOPs)
Manufacturing Order

Manufacturing Order

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Addition of API in an unstable preparation to compensate for loss during manufacture

Overaging

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Designated area for holding of incoming components prior to acceptance testing and qualification for use

Quarantine

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Yellow label

‘under quarantine’
‘approved’
‘rejected’

‘under quarantine’

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Green label

‘under quarantine’
‘approved’
‘rejected’

‘approved’

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Red label

‘under quarantine’
‘approved’
‘rejected’

‘rejected’

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Documented evidence that a system does what it is
supposed to do for consistency and quality)

validation

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Formulates new or reformulates existing products.
Facilities: Library, lab, animal house, pilot plant

Research and Development
Production Department
Quality Assurance Department
Quality Control Department

Research and Development

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Activities: Manufacturing, warehousing (including inventory
control), and storage

Research and Development
Production Department
Quality Assurance Department
Quality Control Department

Production Department

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Assures that all operations meet the required standards for safety and efficacy; ensures compliance to CGMP; conducts
quality audit and monitoring; cooperates with regulatory agencies; prepares SOPS.

Research and Development
Production Department
Quality Assurance Department
Quality Control Department

Quality Assurance Department

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Heart and soul of drug manufacturing; tests compliance of raw materials, packaging materials, In-process, and finished products (via inspection and assay); also conducts sampling and environmental testing

Research and Development
Production Department
Quality Assurance Department
Quality Control Department

Quality Control Department

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Promotion and advertisement

Marketing Department
Regulatory Department
Engineering Department
Medical Department

Marketing Department

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Ensures compliance with all pertinent laws and regulations (LTO and FDA registration, Batch certification of biologicals)

Marketing Department
Regulatory Department
Engineering Department
Medical Department

Regulatory Department

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Locates, installs, repair, maintains equipment. Ensures plan and personnel. Marketing Department Regulatory Department Engineering Department Medical Department

Engineering Department

Physical and medical examination of employees and applicants Marketing Department Regulatory Department Engineering Department Medical Department

Medical Department

Acquires and distributes raw materials or finished products on a wholesale basis Drug Trader Drug Importer Drug Exporter Drug Wholesaler Drug Manufacturer

Drug Wholesaler

Distribute raw materials of finished products to other countries Drug Trader Drug Importer Drug Exporter Drug Wholesaler Drug Manufacturer

Drug Exporter

Responsible for Drug production Drug Trader Drug Importer Drug Exporter Drug Wholesaler Drug Manufacturer

Drug Manufacturer

Registered owner of drug product but subcontracts to toll manufacturer Drug Trader Drug Importer Drug Exporter Drug Wholesaler Drug Manufacturer

Drug Trader

Distribute raw materials or finished products from other countries to other outlets Drug Trader Drug Importer Drug Exporter Drug Wholesaler Drug Manufacturer

Drug Importer

temperature range for storage in a freezer? a) -10 to 2 °C b) 2 to 8 °C c) -20 to -10 °C d) 8 to 10 °C

c) -20 to -10 °C

ideal temperature range for storage in a refrigerator? a) -10 to 2 °C b) 2 to 8 °C c) -20 to -10 °C d) 8 to 10 °C

b) 2 to 8 °C

cold storage condition a) -10 to 2 °C b) 2 to 8 °C c) -20 to -10 °C d) NMT 8 °C

d) NMT 8 °C

cool condition a) -10 to 2 °C b) 2 to 8 °C c) 8 to 15 °C d) NMT 8 °C

c) 8 to 15 °C

prevailing temperature in the work area

Room Temperature

Controlled RT 20 to 25 °C 30 to 40 °C >40 °C

20 to 25 °C

Warm Area 20 to 25 °C 30 to 40 °C >40 °C

30 to 40 °C

Excessive heat 20 to 25 °C 30 to 40 °C >40 °C

>40 °C

Immediate container; has direct product contact; affects stability; may provide means of administration. Ex. Bottles, caps, cap liners, filler, desiccant Primary Packaging Secondary Packaging Tertiary Packaging

Primary Packaging

Outer packaging; encloses primary packaging; optional. Ex. Pallets, shippers, carton box, conjugated box, label, inserts Primary Packaging Secondary Packaging Tertiary Packaging

Secondary Packaging

encloses secondary packaging. Ex. Large boxes Primary Packaging Secondary Packaging Tertiary Packaging

Tertiary Packaging

Impervious to air or any other gas

Hermetic packaging

contains Indicator in case of breach. seals are applied to the packaging in such a way that any attempt to open or tamper with the package will cause visible damage or alteration to the seal.

Tamper-resistant

less subject to thermal stress. Used for aqueous non-buffer solutions Type 1: Ultra-resistant borosilicate glass Type 2: Treated Soda-lime glass Type 3: Regular soda-lime glass Type 4/NP: General purpose soda-lime glass

Type 1: Ultra-resistant borosilicate glass

not resistant to leeching, high temp, chemical attack Type 1: Ultra-resistant borosilicate glass Type 2: Treated Soda-lime glass Type 3: Regular soda-lime glass Type 4/NP: General purpose soda-lime glass

Type 3: Regular soda-lime glass

suitable for acid and neutral preparations both for parental and other use. Type 1: Ultra-resistant borosilicate glass Type 2: Treated Soda-lime glass Type 3: Regular soda-lime glass Type 4/NP: General purpose soda-lime glass

Type 2: Treated Soda-lime glass

low hydrolytic resistance; for oral and topical use preparatins Type 1: Ultra-resistant borosilicate glass Type 2: Treated Soda-lime glass Type 3: Regular soda-lime glass Type 4/NP: General purpose soda-lime glass

Type 4/NP: General purpose soda-lime glass

Non-autoclavable Polypropylene (PP) Polyethylene (PE) Thermoplastic Thermoset

Polyethylene (PE)

For mineral water or beverage bottles, MOST COMMONLY USED Low-density PE (LDPE) PE Terephthalate (PET) High-density PE (HDPE) Polyvinyl Chloride (PVC)

PE Terephthalate (PET)

Hard thermoset; for solid dosage forms Low-density PE (LDPE) PE Terephthalate (PET) High-density PE (HDPE) Polyvinyl Chloride (PVC)

High-density PE (HDPE)

Flexible; for squeeze bottles, sprays bottles, and medicine droppers Low-density PE (LDPE) PE Terephthalate (PET) High-density PE (HDPE) Polyvinyl Chloride (PVC)

Low-density PE (LDPE)

Least resistant to permeation; for blister packs Low-density PE (LDPE) PE Terephthalate (PET) High-density PE (HDPE) Polyvinyl Chloride (PVC)

Polyvinyl Chloride (PVC)

High temperature resistance; for autoclavable plastics Polypropylene (PP) Polyethylene (PE) Thermoplastic Thermoset

Polypropylene (PP)

Soft: flexible and squeezable Polypropylene (PP) Polyethylene (PE) Thermoplastic Thermoset

Thermoplastic

Hard: firm or rigid Polypropylene (PP) Polyethylene (PE) Thermoplastic Thermoset

Thermoset

Flexibility, heat-sealability

Foils

Contains isoprene or neoprene

Rubber

Aluminum, tin, stainless steel

Metal

◆ Cannot be resealed once opened ◆ No antimicrobial agent ◆ Water for injection or sterile water for injection ◆ USP Limit: 1 Liter Single-dose container/Multiple-unit container

Single-dose container

◆ Can be resealed once opened ◆ Has antimicrobial agent ◆ Bacteriostatic water for injection ◆ USP Limit: 30 ml ingle-dose container/Multiple-unit container

Multiple-unit container

Protection from extraneous solids.

Well-closed container

Protection from solids, liquids and vapors

Tight container

Protection from phytochemical deterioration

Light-resistant container

PRINCIPAL DISPLAY PANEL

40%

Widely used because of its physiological compatibility, lack of toxicity and high dielectric constant.

Water

alternation of the polarity of solvent decreasing dielectric constant by the addition of another solvent that is both miscible with water and in which the compound is soluble.

Cosolvency

solubility of a weak base is increased by decreasing the pH; solubility of weak acid is increased by increasing the pH;

Control of pH

may enhanced solubility but may cause a decrease in the activity. Chemical modification Complexation Micellation

Chemical modification

leads to the formation of soluble intramolecular complex which Is usually macromolecular Chemical modification Complexation Micellation

Complexation

spontaneous passage of poorly water soluble solute molecules into an aqueous solution of a soap or a detergent in which a thermodynamically stable solution Is formed. Chemical modification Complexation Micellation

Micellation

for dimercaprolin

arachis oil

for miconazole eye drops and triamcinotone ear drops;

castor oil

alcohol limit for children under 6 yrs old 0.5% 5% 10%

0.5%

alcohol limit for children between 6-12 yrs old 0.5% 5% 10%

alcohol limit for children over 12 yrs old 0.5% 5% 10%

10%

clear, syrup liquid; with sweet taste; miscible with water and alcohol Dimethyl Sulphoxide Propylene Glycol Liquid Paraffin Glycerol

Glycerol

viscous fluid miscible with water and alcohol; Dimethyl Sulphoxide Propylene Glycol Liquid Paraffin Glycerol

Propylene Glycol

polar that is thought to aid in the penetration of drug (idoxuridine) through the skin Dimethyl Sulphoxide Propylene Glycol Liquid Paraffin Glycerol

Dimethyl Sulphoxide

mineral oil; thus used for topical preparation in emulsion form; Dimethyl Sulphoxide Propylene Glycol Liquid Paraffin Glycerol

Liquid Paraffin

solvents for cosmetics Xylene Glycofurol Isopropyl myristate & isopropyl palmitate

Isopropyl myristate & isopropyl palmitate

solvents for ear drops to dissolve earwax Xylene Glycofurol Isopropyl myristate & isopropyl palmitate

Xylene

solvents for parenteral products Xylene Glycofurol Isopropyl myristate & isopropyl palmitate

Glycofurol

added to resist change in the pH of the preparation; important to maintain pH Chelating Agents Preservatives Buffers Antioxidants

Buffers

provide electrons and easily available hydrogen atoms that are accepted more readily by the free radicals; involve in quenching (delay or retard oxidation by rapidly reacting with free radicals as they are formed) Chelating Agents Preservatives Buffers Antioxidants

Antioxidants

Sulfites, hydrophosphorous acids, and ascorbic acid

for aqueous solutions

BHT BHA, alpha-tocopherois, ascorbyl palmitate

for oleaginous preparation

complex or bind the metals to make them unavailable for participation in the oxidative process; calcium disodium edetate or EDTA Chelating Agents Preservatives Buffers Antioxidants

Chelating Agents

prevent the growth of microorganism Chelating Agents Preservatives Buffers Antioxidants

Preservatives

Aspartame; from Methyl ester dipeptide and aspartic acid 180-200

180-200 relative sweetnes

Saccharin from Phthalic anhydride a petroleum product

300 relative sweetnes

Sodium Cyclamate from Sulfonation of cyclohexylanine

30 relative sweetnes

Apricot, butterscotch, liquorice, peach, vanilla, maple, wintergreen

Salty

Anise, chocolate, mint, passion fruit, wild cherry, walnut

Bitter

Vanilla, fruits, berries

Sweet

Citrus fruits, liquorice, raspberry, root beet

Sour

Grape, lemon lime, barberry

Metallic

Alkaline, chocolate, cream, vanilla, mint combination

Alkaline

(water-soluble)

dyes

(water insoluble)

lakes

Acacia, bentonite, tragacanth , alginates, xanthan gum, cellulose derivates

as suspending agent; produce deflocculated system at low concentrations

inorganic used to alter zeta potential;

electrolytes

added to form tablets of a suitable size for handling

Filler (diluent)

added to drug filler mixture to ensure that granules and tablets can be formed with the required mechanical strength

Binder (adhesive)

to ensure that the tablet, when in contact with liquid, breaks up into small fragments, which promotes rapid drug dissolution

Disintegrant

to improve flowability of the powder

Glidant

to ensure that the tablet formation and ejection can occur with low friction between the solid and the die wall

Lubricant

for oils or oil drug solutions to compacted into tablets; microcrystalline cellulose and silica

Sorbents

to produce flexibility and elasticity of the coating and thus provide durability; 20-30%; glycerol, sorbitol, PEG, propylene glycol, diethyl phthalate, dibutyl subacetate, castor

Plasticizers

titanium dioxide; water gel

Opacifiers

to produce smooth, thin films reproducible under conventional coating conditions; cellulose acetate phthalate, HPMC, hydroxypropyl cellulose, methyl cellulose

Film Former

to provide luster to the tablet without a separate polishing operation; beeswax, carnauba wax

Glossant

oleaginous bases; with emollient effects; effective as occlusive dressings; difficult to wash off; limited amount of water and aqueous preparations may be incorporate ◆ Petrolatum ◆ White petrolatum ◆ White ointment ◆ Yellow ointment

Hydrocarbon Bases

→ Those that permit the incorporation of aqueous solutions resulting in the formation of w/o emulsion; hydrophilic petrolatum → Those that are w/o emulsions and permit incorporation of additional quantities of aqueous solutions; Lanolin

Absorption Bases

o/w emulsions resembling creams; easily washed; may be dilute with water or aqueous solutions, have the ability to absorb serous discharges; hydrophilic ointment. completely water washable; no oil; greaseless; not used to incorporate aqueous solutions; polyethylene glycol

Water Removal Bases

hydrogenated fatty acids of vegetable oils; glyceryl monostearate and glyceryl monopalminate

Fatty or Oleaginous Bases

melts between 30-60°C ; exhibit polymorphism; B form is stable; phenol and chloral hydrate may lower the melting point thus solidifying agents like cetyl ester wax (20%) or beeswax (4%) may be added

Cocoa Butter

triglycerides from palm, palm kernel and coconut oils with self-emulsifying glyceryl monostearate and polyoxyl stearate

Fattibase

triglycerides of saturated fatty acids C12 – C18 with varied portions of the corresponding partial glyceride

Witepsol Bases

to reduce adhesion or sticking between the powder and the punch face

Anti-adherent