(Lab) Act 1-5 Flashcards by Kim Grace

cGMP stands for

Current Good Manufacturing Practice

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ensures that medicines are made correctly and safely so that they work as they should and are safe to use.

cGMP

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CGMP rules are made by a government agency called the

FDA

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T/F: Production manager and QC manager should only be PRC registered pharmacis

False. Can be any other related profession (chemist, chemical engineer, etc

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T/F: Production Manager and Quality Control Manager should be two different persons to avoid bias.

True

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T/F; What is not written is not done.

True

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T/F: Production Area should have a sufficient space to minimize clutter and allow smooth flow of
traffic

True

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a process which provides a high degree of confidence or assurance that the said line or area is free from any unwanted residue or left over of previous processing’s before proceeding for next process.

Line clearance

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LABELING REQUIREMENTS A.O

AO 55 s 1988

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Prescribed rules and regulation for the packaging and labelling of food, drugs, devices and cosmetics distributed in the Philippines

Food, Drugs, Device and Cosmetics Art (RA 3720)

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Generics Act of 1988

(RA 6675)

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classification of drug

Pharmacologic/Pharmaceutical Category

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clinical use; use based on what was submitted to FDA

Indication

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GENERIC LABELLING REQUIREMENTS AND BRAND NAME CLEARANCE memorandum

Memorandum Circular No. 16-A s. 1994

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Guidelines to be observed by FDA in clearance of name relative to food, drugs and cosmetics

Bureau Circular No. 21 s. 1999

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Requirements for labeling materials of pharmaceutical products

A.O. No. 55 s. 1988

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Requirements for labeling materials of certain categories of certain categories of products containing 2 or more active ingredients

A.O. No. 85 s. 1990

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Requirements for labeling materials of categories of pharmaceutical products containing 4 or more active ingredients outside the coverage of A.O. no. 85 s. 1990

A.O. No. 99 s. 1990

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Revised rules and regulations governing the generic labeling requirements of drug products for human use

A.O. no. 2016-0008

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T/F: The unit content of each vitamin, mineral and/or herbal ingredient present shall no longer be required to be indicated in the generic box, but rather shall be reflected under FORMULATON

True

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T/F: For multivitamin products with non-vitamin components, or multi-mineral products with non-mineral components; the term “Multivitamin” or “Mineral” or “Herbs”, respectively, shall first stated, followed by the generic name of the specific additional individual components

True

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ALCOA stands for

Attributable, Legible, Contemporaneous, Original, and Accurate.

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Additional Alcoa Principles (+)

Consistent
Complete
Enduring
Available

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Identify the principle: Initials

Attributable

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Identify the principle: Full handwritten signatures (with date and/or time, when applicable/required)

Attributable

Identify the principle: Personal seal

Attributable

Identify the principle: written clearly and readable by both the writer and the reader

Legible

Identify the principle: prohibition of correction fluid/correction tape

Legible

Identify the principle: data superimposition

Legible

Identify the principle: Use of permanent, indelible ink

Legible

Identify the principle: Strict prohibition of use of pencil

Legible

Identify the principle: Strict prohibition of use of erasable pens

Legible

Identify the principle: "same time", two actions happening at the same time

Contemporaneous

Identify the principle: undocumented action is an action that did not happen

Contemporaneous

Identify the principle: Date and time of the action should be indicated when required

Contemporaneous

Identify the principle: NO back-dating ("ante-dating”)

Contemporaneous

Identify the principle:NO forward-dating ("advance dating”)

Contemporaneous

Identify the principle: all data required must be captured and explicitly recorded (brackets/braces/ditto marks (“) are not allowed to imply repetitive/same data. Use of N/A if field is not applicable.)

Complete

Identify the principle: data are presented, recorded, dated, in defined sequence (date/time stamps)

Consistent

Identify the principle: data and records must be sustained throughout their retention period

Enduring

Identify the principle: data must be available anytime it is requested to be reviewed during inspection/regulatory audit

Available

T/F: bioequivalence issues are minimally observed in liquid manufacturing

True (except for suspension)

T/F: For syrups, elixirs or solutions in which nothing is suspended, the particle size and physical characteristics of the raw material are not that significant but these can still affect the rate of dissolution during the manufacturing process.

True

Examples of heterogenous system

suspension, magmas, emulsion, lotions and gels

Most common solvent used

Purified Water, USP

pH of Purified Water, USP must be at

pH 5-7

commonly used % of alcohol

95% ethanol

Primary solvent for organic compounds

Alcohol, USP

At certain concentrations, what % of alcohol is self preserving

10-12%

% sufficient alcohol to maintain the drug in the solution

5-40%

Clear, syrupy liquid with a sweet taste

Glycerin

Used as stabilizer and co solvent

Glycerin

Substitute to glycerin

Propylene Glycol

Common used preservatives:

Benzoic acid, Sodium Benzoate, Parabens

T/F: Propylparaben and methylparaben can be used alone or in combination

In what ratio do propylparaben and methylparaben produce a synergistic effect that gives a higher total preservative concentration or action

1:10

employ something that has a stronger flavor to mask the unpleasant taste

Masking/Overshadowing

a barrier is utilized in order to reduce the contact of the drug with receptors present in taste buds

Physical Method

involves chemical reaction to mask the taste

Chemical method

using ingredients that either compete with the drug for the receptor site or by desensitizing taste buds

Physiological method

Clear, sweetened hydroalcoholic solution intended for oral use and are usually flavored to enhance their palatability

Elixirs

Sugar + alcohol

Elixirs

T/F: Elixirs are prepared by simple solution with agitation and/or by the admixture of two or more liquid ingredients.

True

T/F: elixirs are less effective in masking the taste of medicinal substances or APIs because they are less sweet and less viscous

True

Used to treat coughs and congestions usually caused by common colds

Guaifenesin Oral Solution or Elixir

Guaifenesin Oral Solution or Elixir Acts by _____________ the mucus in the airways and making coughs _____________

loosening; more productive

T/F: Turbidity in making elixirs is a wanted outcome.

False

What to do when Elixir turns turbid?

Add filtering aid , Stir, Stand overnight

T/F: The alcohol content when present in a pharmaceutical product must be expressed in % alcohol strength in the formulation.

True

Standard concentration of alcohol used:

95%

critical role in the control of microbial growth

Sucrose concentration

T/F: Diluted sucrose solution = prone to microbial contamination

true

>85% concentration (syrup)

prone to recrystallization

85% concentration (syrup):

self-preserving

65 to 80% concentration (syrup)

stable

<60% concentration (diluted conc.)

prone to microbial growth which serves as an excellent media for yeast

allow purified water or aqueous solution to pass slowly to a bed of crystalline sucrose packed or placed in a percolator thus dissolving the sucrose

Percolation

faster and requires a shorter time; produces yello syrups;

Solution with aid of heat

Excessive heat leads to

inversion of sucrose

If inversion happens, sweetness of product is greatly __________ because invert sugars are _________ than sucrose

altered; sweeter

Performed in order to ensure maximum stability; time consuming

Solution without aid of heat

ADR of paracetamol

hepatotoxicity

pharmaceutical category of paracetamol syrup

Analgesic/Antipyretic

(Paracetamol) Toxic dose

single dose of more than 10g

(Paracetamol) Children of 2 years of age

dose of more than 3g

Recommended maximum daily dose of paracetamol for adults is

4 grams

Green vitriol; Pale bluish green crystal; Hygroscopic

FERROUS SULFATE SYRUP

T/F: if ferric sulfate is brownish yellow, it can no longer be used as raw material

Ferric sulfate

Pharmacologic Category of FeSO4

Hematinic

For iron deficiency anemia; can increase hemoglobin content of RBC

Hematinic (FeSO4)

Iron is best absorbed on a/an __________ stomach usually taken 1 hour before meal or 2 hours after meal

empty

12% elemental iron by weight NH; least GI effect

Fe gluconate

33% elemental iron by weight; fortified in dry cereals; more stable than Fe sulfate

Fe fumarate

20% elemental iron by weight; most readily by the GUT but when added to dry cereals, it can promote spoilage and rancidity; most common S/E is constipation

Fe sulfate