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

Question 1

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

Answer 1

Agitators

Question 2

solvent recovery and other evaporation applications.

Answer 2

Blowers

Question 3

Apply heat energy to water to create steam

Answer 3

Boilers

Question 4

filling polishing, and sorting capsules.

Answer 4

Capsule equipment

Question 5

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

Answer 5

Capsule and tablet printers

Question 6

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

Answer 6

Centrifuges

Question 7

lower temperatures quickly

Answer 7

Chillers

Question 8

coat tablets or capsules with films like a sugar film.

Answer 8

Coaters

Question 9

cooling liquids or condensing steam.

Answer 9

Cooling towers

Question 10

drying liquid preparations into powders or granules.

Answer 10

Dryers and Granulators

Question 11

transfer heat from one medium to another.

Answer 11

Heat exchangers

Question 12

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

Answer 12

Inspection machines

Question 13

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

Answer 13

Metal detectors

Question 14

blending and particle size reduction.

Answer 14

Mixers

Question 15

providing necessary heat or drying.

Answer 15

Ovens

Question 16

Particle size reduction equipment for granules.

Answer 16

Pulverizers / Cone mills

Question 17

produces tablets.

Answer 17

Tablet press

Question 18

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

Answer 18

Tablet deduster

Question 19

sieves powders or granules.

Answer 19

Sifters

Question 20

spray coats liquid onto a powder.

Answer 20

Spray coating machines

Question 21

holds liquids.

Answer 21

Tanks

Question 22

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

Answer 22

Blister packers

Question 23

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

Answer 23

“Deblistering” machines

Question 24

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

Answer 24

Bottling and filling lines

Question 25

place caps onto filled bottles or containers of medicines.

Answer 25

Cappers

Question 26

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

Answer 26

Cartoners

Question 27

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

Answer 27

Counters

Question 28

Seals aluminum foil seals to the bottle mouth.

Answer 28

Induction Sealers

Question 29

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

Answer 29

Labeling equipment

Question 30

fills and seals tubes of ointments, creams and gels.

Answer 30

Tube fillers

Question 31

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.

Answer 31

N/A

Question 32

Significant and highly catastrophic impact on product

Answer 32

CRITICAL - 1

Question 33

Significant losses and respectively addressed management intervention required

Answer 33

HIGH - 2

Question 34

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

Answer 34

MODERATE - 3

Question 35

Impact on operation and efficiency, but limited

Answer 35

MINOR - 4

Question 36

Very minor or no impact on operations and quality product efficacy

Answer 36

INSIGNIFICANT - 5

Question 37

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

Answer 37

Corrective Action

Question 38

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

Answer 38

Preventive Action

Question 39

CAPA FRAMEWORK:

Answer 39

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

Question 40

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

Answer 40

CAPA processes

Question 41

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

Answer 41

FDA 21 CFR 820

Question 42

•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.

Answer 42

N/A

Question 43

Consequences of Noncompliance With Manufacturing SOPs:

Answer 43

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

Question 44

Manufacturing SOPs help produce high-quality products consistently

Answer 44

Lack of quality control

Question 45

Manufacturing SOPs are designed to improve efficiency

Answer 45

Low productivity

Question 46

SOPs clearly define worker tasks and responsibilities

Answer 46

Subjective performance evaluations

Question 47

SOPs communicate process updates to workers

Answer 47

Communication breakdown

Question 48

Safe work practices are often integrated into manufacturing SOPs

Answer 48

Increased risk of accidents

Question 49

MODEL FORMAT FOR AN EFFECTIVE SOP:

Answer 49

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