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1
Q

large-scale production of drug products’ preparation, processing, packaging, labeling, repacking, changing wrapper, label or container of any drug products

A

manufacturing

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2
Q

Stages of Manufacturing

A
  • Dispensing of Raw Materials
  • Processing of Dosage Forms
  • Filling
  • Packaging and Repacking
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3
Q

manufacture of raw material (APIs and
Excipients)

A

Primary Manufacturing

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4
Q

manufacture of finished dosage form

A

Secondary Manufacturing

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5
Q

packaging, labeling, and repacking of bulk finished product

A

Tertiary Manufacturing

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6
Q

an arrangement whereby a competent company manufactures products for another company

A

Toll Manufacturing

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7
Q

Revised Regulations for the Licensing of Drug Establishments and outlets

A

AO 56 s.1989

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8
Q

Rules and Regulations on the Licensing of Establishments Engaged in the Manufacture, Conduct of Clinical Trial, Distribution, Importation, Exportation, and Retailing of Drug Products, and Issuance of Other Related Authorization

A

AO 2014-0034

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9
Q

involved in production of drugs products (preparatory processing, compounding, formulating, filling, packaging, repackaging, altering, ornamenting, finishing, labeling)

A

Manufacturer

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10
Q

involved in packaging of bulk drug product to its immediate container

A

Packer

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11
Q

involved in repackaging of finished product into smaller quantities in a separate container and/ or secondary packaging

A

Repacker

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12
Q

Registered owner of drug product and formulation but subcontracts manufacturing

A

Trader

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13
Q
  • Procures RM and PM
  • Provides monographs and QC protocols
A

Trader

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14
Q

Drug Manufacturers:

A

Manufacturer
Packer
Repacker
Trader

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15
Q

imports RM, API, and/or finished products for wholesale distribution to other licensed established

A

Importer

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16
Q

exports RM, API, and/ or finished products for wholesale distribution to establishments outside the country

A

Exporter

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17
Q

procures RM, API, and/ or finished products from a local licensed establishment for local distribution in wholesale basis

A

Wholesaler

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18
Q

Drug Distributors

A

Importer
Exporter
Wholesaler

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19
Q

• formulates new products

• involved in process development and scale-up

• prepares Master formula

A

Research and Development Dept

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20
Q

Stages of Drug Development

A

1) Discovery and Development
2) Preclinical Research
3) Clinical Research
4) FDA Review
5) Post-market Surveillance

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21
Q

contains the formulation, specifications, manufacturing procedures, QA requirements, and labeling of a finished product

A

Master formula

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22
Q

addition of an excess amount of API in an unstable preparation

A

Overages

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23
Q

• prepares Master formula
• justifies overages in the formula

A

Research and Development Dept

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24
Q

• deals with all stages of manufacturing batches of finished drug products

• Plans the production according to MO

A

Production Dept

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25
specific quantity of product intended to have uniform character and quality, produced during the same single cycle of manufacture
Batch
26
specific identified portion of a batch
Lot
27
gives instructions to manufacture a product
Manufacturing Order (MO)
28
• accomplish the BMR to ensure that batches were properly made and tests were conducted
Production Dept
29
document containing the details of the manufacture of each batch
Batch Manufacturing Record (BMR)
30
• stores materials and finished products • holds incoming components in the quarantine area • involved in purchasing and logistics
Warehouse Dept
31
status of materials which are isolated physically while a decision is awaited on their release, rejection, or reprocessing
Quarantine
32
• assures that all operations meet required standards for safety and efficacy, ensures compliance to cGMP • conducts quality audit and monitoring • prepares SOPs
Quality Assurance Dept
33
step-by- step instructions for performing operational tasks or activities
Standard Operating Procedures (SOP)
34
• tests compliance of raw materials, packaging materials, and finished products to specifications • conducts sampling of materials to be tested • performs IPQC and environmental testing
Quality Control Dept
35
• studies current market trends, consumer behavior and product status in market • promote and advertisement
Marketing Department
36
ensures compliance of company and its products with all pertinent regulations and laws about drugs and their marketing
Regulatory Dept
37
• installs, maintains and repairs of equipment and premises • conducts validation and qualification • ensures safety
Engineering Department
38
action of proving and documenting that any process, procedure or method actually and consistently leads to the expected results
Validation
39
action of proving that premises, systems or equipment work correctly and actually lead to expected results
Qualification
40
• concerned with physical examination and medical treatment of employees • performs clinical studies • publishes house organ/paper
Medical Dept
41
• inert substance added to increase tablet size or fill the capsule body
Diluent (Filler/ Bulking Agent)
42
• Most common diluent • No reaction with most drugs • Monohydrate, anhydrous, and spray-dried
Lactose
43
• Used as sweetener
Sucrose and Dextrose
44
• Good flow and very compressible • Disintegrates rapidly in water
Microcrystalline Cellulose (Avicel®)
45
• Used as diluent, binder and disintegrant
Starch
46
• Only inorganic salt used as diluent
Dibasic calcium Phosphate
47
• Used in chewable tablet s • Negative heat of solution
Mannitol and xylitol
48
• Imparts cohesiveness to powders causing them to from granules
Binder
49
• Binder of choice for wet gran
Starch Paste
50
• Natural guns
Acacia & Tragacanth
51
• an economic way of protecting, preparing, identifying, and containing the drug products • composed of container and closure
Packaging
52
• in direct contact with product • immediate container • affects stability • may provide means of administration
Primary Packaging
53
Examples of Primary Packaging
bottles, caps, liners, filler, desiccant
54
• outer packaging (not always present) • encloses primary packaging
Secondary Packaging
55
Examples of Secondary Packaging
carton box, sticker label, inserts, conjugated box
56
Types of Packaging
Primary Secondary
57
• protects content from extraneous solids
Well-closed
58
• protects contents from extraneous solids, liquids, and vapors • protects from deliquescence, efflorescence, evaporation
Tight
59
• impervious to air or any other gas
Hermetic
60
• protects from photochemical degradation • amber bottles
Light-Resistant
61
• difficult for children under 5 years of age to open • press down and turn 1. • squeeze and turn • alight the arrows • latch top
Child-Resistant
62
• uses an indicator which if breached or missing can provide evidence that tampering has occurred
Tamper-resistant
63
• shrink seal/ wrap • breakable caps • tape seal • bottle seal • aerosol
Tamper-resistant
64
only true temper-resistant packaging
aerosol
65
Containers According to Protection Ability
• Well-closed • Tight • Hermetic • Light-Resistant • Child-resistant • Tamper-resistant
66
• contains a single dose only and packaged in non- resealable containers • no antimicrobial agent; water: WFI or SWFI; USP limit: 1000 mL • ampoules, prefilled syringes
Single Unit
67
Advantages of Single Unit container
- low cost - not breakable - light weight - chemically inert
68
Disadvantages of single unit container
- permeable - low heat resistance - not as clear as glass - poor physical stability
69
• contains multiple doses and packaged in resealable containers • with antimicrobial agent; water: BWFI; USP limit: 30 mL • vials
Multiple unit
70
• most widely used, made up of inorganic compounds (major component: SiO2)
Glass
71
Advantages of Glass
- rigid and transparent - impermeable - chemically resistant - can be easily sterilized
72
Disadvantages of Glass
- high cost - fragile - relatively heavy - prone to leaching
73
• organic polymers of HMW
Plastic
74
Types of Glass
• Highly Resistant Borosilicate (Pyrex, Borosil) • Treated Soda Lime Glass • Soda Lime Glass • General Soda Lime Glass
75
soft when heated and hard when cooled; flexible and squeezable
Thermoplastic
76
permanently hard; rigid
Thermoset
77
Types of Plastic
Thermoplastic Thermoset
78
decrease coefficient of expansion
Boron
79
Types of Polymers for Plastic
• Polyethylene Terephthalate • High-density Polyethylene • Polyvinyl Chloride • Low-density Polyethylene • Polypropylene
80
used for beverages
Polyethylene Terephthalate
81
hard thermoset for solid dosage forms
High Density Polyethylene
82
used for blister packs
Polyvinyl Chloride
83
thermoplastic for squeeze bottles and medicine droppers
Low-density Polyethylene
84
used for autoclave containers
Polypropylene
85
Used in aerosol cans and collapsible tubes
metals
86
• Used in blister packs and strip packs
Foils, Films and Laminates
87
• Used in vial stoppers and syringe plugs
Rubber
88
• Used in vial stoppers and syringe plugs
Rubber
89
Storage Condition: Cold
NMT 2 to 8°C
90
Refrigerator SC
2 to 8 degrees C
91
Freezer SC
-20 to -10°C
92
Cool SC
8 to 15°C
93
Cool SC
8 to 15°C
94
Room Temperature SC
temperature prevailing in the area
95
Controlled Room Temperature
20 to 25°C
96
Warm SC
30 to 40°C
97
Controlled Room Temperature
20 to 25°C
98
used for divided powders
Paper
99
Excessive Heat
> 40°C

MANU (13 decks)

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