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Pharmaceutical Manufacturing > Lab - RMP,CAPA,SOP, equipment, etc. > Flashcards

Lab - RMP,CAPA,SOP, equipment, etc. Flashcards

1
Q

mix liquids, promote chemical reactions and increase heat or cooling transfers.

A

Agitators

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2
Q

solvent recovery and other evaporation applications.

A

Blowers

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3
Q

Apply heat energy to water to create steam

A

Boilers

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4
Q

filling polishing, and sorting capsules.

A

Capsule equipment

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5
Q

printing information like drug names or dosage on the capsules or tablets.

A

Capsule and tablet printers

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6
Q

Separate liquids of different densities, or for separation of liquids from solids.

A

Centrifuges

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7
Q

lower temperatures quickly

A

Chillers

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8
Q

coat tablets or capsules with films like a sugar film.

A

Coaters

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9
Q

cooling liquids or condensing steam.

A

Cooling towers

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10
Q

drying liquid preparations into powders or granules.

A

Dryers and Granulators

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11
Q

transfer heat from one medium to another.

A

Heat exchangers

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12
Q

Visual inspection of products as they move along through rotating rollers.

A

Inspection machines

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13
Q

Detect tramp metal (bits of metal like nuts, screws, or broken fragments of machinery) that may have contaminated the product.

A

Metal detectors

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14
Q

blending and particle size reduction.

A

Mixers

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15
Q

providing necessary heat or drying.

A

Ovens

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16
Q

Particle size reduction equipment for granules.

A

Pulverizers / Cone mills

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17
Q

produces tablets.

A

Tablet press

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18
Q

removes dust created in the tablet press also used to polish tablets

A

Tablet deduster

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19
Q

sieves powders or granules.

A

Sifters

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20
Q

spray coats liquid onto a powder.

A

Spray coating machines

21
Q

holds liquids.

A

Tanks

22
Q

pack tablets, capsules, softgels, injection solutions, syringes and other small medical items into blister packs.

A

Blister packers

23
Q

are also available to recover tablets, capsules or softgels from blister packs.

A

“Deblistering” machines

24
Q

fills bottles with liquids or containers with tablets, capsules or softgels.

A

Bottling and filling lines

25
Q

place caps onto filled bottles or containers of medicines.

A

Cappers

26
Q

fill small medicine boxes with blisters packs, fold and insert leaflets, and close, code, and seal the box.

A

Cartoners

27
Q

Counts capsules, tablets, softgels and any other small, solid items.

A

Counters

28
Q

Seals aluminum foil seals to the bottle mouth.

A

Induction Sealers

29
Q

attaches or prints labels onto the packaging of boxes, bottles, containers, tubes etc.

A

Labeling equipment

30
Q

fills and seals tubes of ointments, creams and gels.

A

Tube fillers

31
Q

Premises
➢ Situated in environment that protects manufacture, presents minimal risk of causing contamination and materials.
➢ Carefully maintained, ensuring that repair and maintenance operations do not present any hazard to the product’s quality. They should be cleaned and where applicable, disinfected according to written detailed procedures.
➢ Lighting, temperature, humidity and ventilation should be appropriate.
➢ Designed and equipped to afford maximum protection.
➢ Production, storage and quality control areas should not be used as right of way by personnel not working in these areas.

A

N/A

32
Q

Significant and highly catastrophic impact on product

A

CRITICAL - 1

33
Q

Significant losses and respectively addressed management intervention required

A

HIGH - 2

34
Q

Loss of operating capability, long term and problem causes adverse effect

A

MODERATE - 3

35
Q

Impact on operation and efficiency, but limited

A

MINOR - 4

36
Q

Very minor or no impact on operations and quality product efficacy

A

INSIGNIFICANT - 5

37
Q

Elimination of the cause or causes of an existing nonconformity or undesirable situation in order to
prevent recurrence.

A

Corrective Action

38
Q

Identification and elimination of the
cause(s) of potential nonconformities in order to prevent
occurrence.

A

Preventive Action

39
Q

CAPA FRAMEWORK:

A

PLAN - define root cause
DO - Research solution
CHECK - verify solution works
ACT - implement solution

40
Q

are used particularly in food
processing, medical device development and manufacturing, and pharmaceuticals.

A

CAPA processes

41
Q

is the quality system regulation that requires corrective and preventive procedures to be documented in
medical device manufacturing facilities.

A

FDA 21 CFR 820

42
Q

•Promptly identify and document the problem
•Implement a correction or containment or temporary repair
•Find the cause of the issue
•Determine the solution that will prevent a recurrence
•Implement the corrective action and ensure that everything is documented.
•Verify that the action continues to be effective and that the problem does not recur.

A

N/A

43
Q

Consequences of Noncompliance With Manufacturing SOPs:

A

Lack of quality control
Low productivity
Subjective performance evaluations
Communication breakdown
Increased risk of accidents

44
Q

Manufacturing SOPs help produce high-quality products consistently

A

Lack of quality control

45
Q

Manufacturing SOPs are designed to improve efficiency

A

Low productivity

46
Q

SOPs clearly define worker tasks and responsibilities

A

Subjective performance evaluations

47
Q

SOPs communicate process updates
to workers

A

Communication breakdown

48
Q

Safe work practices are often
integrated into manufacturing SOPs

A

Increased risk of accidents

49
Q

MODEL FORMAT FOR AN
EFFECTIVE SOP:

A

Header
1. Purpose
2. Scope
3. References and Related Documents
4. Definitions
5. Roles and Responsibilities
6. Procedure
7. Appendices
8. Revision History
Approval Signature

Pharmaceutical Manufacturing (9 decks)

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