Pharmaceutical Manufacturing Flashcards
Preparation, processing, packaging, repacking, labelling, changing of container, wrapping or label.
PHARMACEUTICAL MANUFACTURING
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
manufacturing that involves the production of finished dosage forms?
a) Primary Manufacturing
b) Secondary Manufacturing
c) Tertiary Manufacturing
d) Toll Manufacturing
b) Secondary Manufacturing
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
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.
Specific quantity of product produced during a single manufacturing process
Batch
Lot
Batch/ Lot Number
Batch
Specific portion of batch
Batch
Lot
Batch/ Lot Number
Lot
For identification and traceability of a single batch/ lot
Batch
Lot
Batch/ Lot Number
Batch/ Lot Number
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
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)
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)
Give instructions to production department to produce product
Master Formula
Batch Manufacturing Record (BMR)
Standard Operating Procedures (SOPs)
Manufacturing Order
Manufacturing Order
Addition of API in an unstable preparation to compensate for loss during manufacture
Overaging
Designated area for holding of incoming components prior to acceptance testing and qualification for use
Quarantine
Yellow label
‘under quarantine’
‘approved’
‘rejected’
‘under quarantine’
Green label
‘under quarantine’
‘approved’
‘rejected’
‘approved’
Red label
‘under quarantine’
‘approved’
‘rejected’
‘rejected’
Documented evidence that a system does what it is
supposed to do for consistency and quality)
validation
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
Activities: Manufacturing, warehousing (including inventory
control), and storage
Research and Development
Production Department
Quality Assurance Department
Quality Control Department
Production Department
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
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
Promotion and advertisement
Marketing Department
Regulatory Department
Engineering Department
Medical Department
Marketing Department
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
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%
5%
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
