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Prod331 > Microbial Stability Of Formulations/GMP/GLP > Flashcards

Microbial Stability Of Formulations/GMP/GLP Flashcards

1
Q

What is a pharmaceutical raw material?

A

A substance that is used in the manufacturing of pharmaceutical products

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2
Q

What is it necessary to do under GMP regulations in the pharmaceutical industry?

A

Control microbiological contamination

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3
Q

What does GMP stand for

A

Good manufacturing practice

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4
Q

What testing does sterile and non sterile products have to undergo to meet the specifications in the pharmacopeia

A

Microbiological testing

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5
Q

What are tests based on?

A

Type and form of the dosage`

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6
Q

What are the methods for isolation of microorganisms from cosmetic products?

A

Direct colony counts and enrichment culturing

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7
Q

How can microbial contamination affect consumers and the product?

A

Can be a consumer safety concern and may adversely affect product stability

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8
Q

What does CFU stand for?

A

Colony forming unit

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9
Q

What is CFU used for?

A

CFU is used in microbiology to estimate the number of viable bacteria or fungal cells in a sample

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10
Q

What is the traditional method for quantitative population analysis?

A

Relies on plating of serial dilutions and subsequent counting of colony forming units

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11
Q

What are modern teqniques for quantitate population analysis?

A

High-throughput, methods relying on quantitative PCR

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12
Q

What is done with products that are not soluble in water?

A

They are treated to render them miscible before isolation techniques are conducted

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13
Q

Why is it important to have an effective preservation system for natural or sustainable products?

A

Natural ingredients may serve as growth media for bacteria, yeast and mold if not adequately preserved

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14
Q

Which critical factors should be considered when developing a preservation system for complex products?

A

The performance of a preservation system can be positively or negatively affected by the formulation composition and process conditions to which it’s exposed

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15
Q

How should a liquid sample be prepared?

A

Decimally dilute 1mL of liquid directly into 9mL of modified lee then broth (MLB) in screw cap test tubes for the 10-1 dilution

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16
Q

How should a solid/powder sample be prepared

A

Weigh 1g of sample into a screw cap test tube containing 1ml of sterile Tween 80. Disperse product with a sterile spatula. Add 8ml of MLB and mix thoroughly

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17
Q

How should cream/oil based samples be prepared?

A

Remove and weigh 1g of sample into a screw top test tube containing 1mL of sterile tween 80 and 5-7 glass beads. Mix contents with vortex mixer, adjust total volume to 10mL with sterile MLB.

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18
Q

How should areoles of powders/soaps/liquids/other materials be prepared?

A

Decontaminate nozzle of spray can, peel some product to flush out nozzle, spray appropriate amount into taped dilution bottle, mix product and broth, reweigh

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19
Q

Describe preservatives

A

They are antimicrobial compounds that are added to topical formulations to protect both the product and the consumer from microbial contaminants that may be introduced during normal use.

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20
Q

What do attributes of optimal preservation system include?

A

Broad spectrum antimicrobial activity at low concentration, efficacy over a wide range of pH and temperature, compatibility with other ingredients with the packaging material, high water solubility, relatively low cost (cost effective)

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21
Q

Which key factors should be considered when designing a topically applied formulation with an optimal preservation system?

A

Type of formulation (lotion, gel, emulsion), intended use (leave on, rinse off, eye area), consumer safety (no or minimal risk for skin sensitisation and irritation), regulatory limitations (global acceptance, if possible), type of packaging (open jar or enclosed packaging), manufacturing, storage and distribution conditions `

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22
Q

How is preservative testing done?

A

Similar to microbiolgy testing in the lab, averagee log reduction

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23
Q

Who is responsible for safety according to EU and FDA

A

The companies and individuals who market the product are responsible under normal, foreseeable conditions of use

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24
Q

At what point does a commercial cosmetic have to be free from microbial contamination

A

Moment of reaching the market through the product life

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25
Q

What does GMP provide?

A

Guidlines for production, control, storage and shipment

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26
Q

What must each product placed on the market have according to EU regulations?

A

Product information file (PIF)

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27
Q

What is a PIF?

A

Product information file contains a great deal of information about the cosmetic product, including the physiology-chemical stability traces, impurities, packaging interactions and microbiological quality of both raw materials and the cosmetic product

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28
Q

What does the PIF need to contain?

A

Description of the cosmetic product, cosmetic product safety report, method of manufacture, proof of the effect claimed, data on tested animal

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29
Q

What are the 2 categories for microbiological requirements?

A

Category 1 products specifically intended for children under 3 or to be used in the eye area and on mucous membrane. Category 2 other products

30
Q

In NZ what is cosmetics that contain hazardous substances regulated under?

A

Hazardous substance and new organisms legislation

31
Q

In NZ who manages the standards set by the hazardous substance and new organisms legislation?

A

EPA, environmental protection authority

32
Q

Are the most toxic compounds on earth natural or synthetic?

A

Natural

33
Q

What are NZ regulations based on?

A

EU regulations

34
Q

What is GMP?

A

A universal concept to make pharmaceutical products both safe and consistent in their effectiveness

35
Q

What is cGMP?

A

Current good manufacturing practise

36
Q

When was GMP first introduced?

A

1978

37
Q

How can biological products be defined?

A

By their source material and method of manufacture

38
Q

What are two factors that are critical in shaping the regulatory control for biological products?

A

Source materials and methods employed in the manufacture

39
Q

What are biological products?

A

Derived from cells tissues or microorganisms and reflect the inherent variability characteristic of living materials.

40
Q

What causes special considerations to be needed when manufacturing biological products, so to maintain consistency in product quality?

A

The active substance in biological products are often too complex to be fully characterised by utilising physiochemical testing alone and may show marked heterogeneity from one batch to the next.

41
Q

Who is the NZ medicine and medical devices safety authority?

A

Medsafe

42
Q

What is medafe responsible for?

A

The regulation of therapeutic products

43
Q

What is GLP?

A

Good laboratory practices

44
Q

Where and when was GLP first introduced?

A

NZ and Denmark in 1972

45
Q

Why was GLP introduced in the US?

A

In response to the industrial bio test lab scandal

46
Q

What is the intent of GLP?

A

To regulate the practices of scientists workingg on the safety of prospective drugs

47
Q

Are GLPs formal regulations? What does this mean?

A

Yes, this means they are laws

48
Q

What are the 5 steps in GLP

A

Resources, Charecterization, Rules, Results, Quality assurance

49
Q

Describe the resources step in GLP

A

Organisation and personnel GLP regulations require that the structure of R&D organisations and the responsibilities of R&D personnel be clearly defined. GLP also states there should be sufficient staff to perform the task required

50
Q

Describe the characterisation step in GLP

A

In order to perform a study correctly, it is essential to know as much as possible about the material used during this study

51
Q

Describe the rules step in GLP

A

Protocols and written procedures the main steps of research studies are prescribed win the study plan or protocol, being able to repeat studies to retain similar results

52
Q

Describe the results step in GLP

A

Raw data, final report, archives

53
Q

Describe the quality assurance step in GLP

A

A team of persons charged with assuring management that GLP compliance has been obtained with the lab

54
Q

What is IANZ

A

The operational unit of the testing laboratory registration council, they give guidance on GLP

55
Q

What are the 4 stages of drug development?

A

Discovery, non-clinical, clinical, post approval

56
Q

How long do the 4 stages of drug development take?

A

Approx. 12 years

57
Q

What is a product recall?

A

When a product doesn’t meet the required quality or safety standards, a company will often voluntarily recall the item by ensuring retailers no longer sell the impacted goods and imploring customers to discontinue the recalled product

58
Q

Why are products recalled?

A

Safety and quality reasons- Contamination, mislabeled product, undeclared ingredient, overall saftey

59
Q

Describe Contamination in terms of product recall

A

E. coli and other bacterial contamination are known but, this includes other contaminant such as a foreign object/unintentional ingredient addition (even if its not harmful) metal, plastic bits…

60
Q

Describe mislabeled product in terms of product recall

A

Improperly labeled foods, cosmetics, medicines can be recalled for incorrectly listing ingredients, having improper expiration dates etc.

61
Q

Describe undeclared ingredients terms of product recall

A

For example a product containing ingredients not present on the label, this can be especially important with potential allergens

62
Q

Describe overall safety in terms of product recall

A

We’ll see infant formula recalled for not maintaining the proper nutritional balance, dispensing medicine properly and many more potential safety issues

63
Q

How may drug recalls happen per year in the US market?

A

4500

64
Q

How many classes are drug recalls classified into?

A

3

65
Q

What is class 1 for drug recalls?

A

Recall of products which can prove fatal or lead to serious health problems

66
Q

What is class 2 for drug recalls?

A

Recall of products which can lead to temporary health issues or are not a huge threat for health

67
Q

What is class 3 for drug recalls?

A

Recall of product which do not pose any dangerous threat but are not complaints with the regulations HA

68
Q

Why are drugs recalled?

A

Hazardous nature, contaminated ingredients, defects in manufacturing, errors in labelling

69
Q

Which product category had the most product recalls?

A

Toys

70
Q

How much of an increase in recalls was was there in 2016 for cosmetics? What was the cause of these recalls?

A

63%, chemical and microbiology issues

Prod331 (6 decks)

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