Unit 5 Flashcards by Eb Nac

flow of quality drug product onto the market relies upon

controlled and consistent pharmaceutical
manufacturing practice

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Diff activities and processes we do in manufacturing firm to ensure the quality of out material s an equipment while they are being manufactured

Manufacturing control

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How to handle raw material

Material control

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Process of systematic examination of quality "official inspection" carried by an internal/ external quality auditor

Quality audit

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Manufacturers need to do to begine the manufacturing co troll

Audit

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Determine which steps in the production line have most impact on the quality and consistency of the final product

Risk analysis

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Failure in audit

Published publicly and result in dismissal of qc certification

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Need by industry to help control products from drug discovery through the manufacturing process

Data management approach

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Assure product for release to help ensure the final product meet the companys quality criteria, process use to design test will be done correctly

Quality Assurance

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Pahrmaceutical manufacturer challenges

Manufacturing
Pricing
Distribution
Drug discovery

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Regulatory body of the Philippines

FDA

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Effort of regulatory bodies try to allign what their requirements are

International conference on Harmonization

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Basic document form where the master formula and batch production records are based

Manufacturing Monograph

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Documents used in drug manufacture

Manufacturing Monograph
Master formula record/ master production Record
Batch Production Record
Quality Control Monograph
Standard operating procedures
In-process quality control

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Contain standard for medical dosage forms drug substances excipient, biologicals, compounded preparation, medical device, dietary supplement and other therapeutics

USP-NF

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Uses of standards of USP-NF

quality of medicine
Safety of patient

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USP NF includes

Quality standards for medicine
API
Excipient

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Aka: master batch record/ master manufacturing Formula

Master Formula Record/Master Production Record

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One of the most important aspect of any manufacturing procedure

Consistency

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Standards for satge 3 dissolution

Ave. 24 is nlt Q
2 tabs nlt Q-15
No tab nlt Q-25

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Documents when, how, by whom with what tools and in what environment a product was produced

Batch production Record

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Contents of BPR

Product formula
Manufacturing procedures
Production record
Raw material records
Packaging material record
Product experience reports

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All ingredients include amount

Product formula

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All steps in all stages of MP like sifting lubricating milling coating

Manufacturing procedures

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Processing batch record

Production record

All. Info regarding active pharmaceutical ingredients and excipient

Raw material records

List of packaging material with quantity

Packaging material record

History of each batch of product

Product experience reports

Specific amount produced in a unit of time Produced by one manufacturing order during same cycle

Batch

Specified portion of a batch having uniform character and quality w/in specified limits

Lot

Combination of markings, letters by which the history of a manufacture and control of a batch or lot can be determined

Batch number Lot number Control number

Letteres and numbers identified on the label

Control codes

Written document that reflects the quantity attributes of medicine approved by FDA To guarantee product quality

Quality control monograph

Articulate quality expectations for a medicine or identity and security and Performance Describe test to validate that medicine or drug and its ingredients meet criteria

Monograph

Rely on precision rigor and consistency to produce quality products to arrive the kind of culture that consistently and effectively produces result of nature

Pharmaceutical manufacturer

Generated to explain in detail the reason behind a procedure and proper sequence to be done and how an equipment is to be operated for maximum performance

Standard operating procedures

Set of written instructions document a routine or repetitive activity that is followed by the employees

SOP

Provide information to perform a job properly and consistently to achieve prederetmined specs and a quality end result

SOP

Test to control before manufacturing process completed to ensure products quality is meet before they approve for consumption

IPQC

Tets performed to determine if the product meets specifications through out the entire processing period

In-process Quality Control

Purpose is to determine any out or range measurement cann be corrected before further processing is continued

IPQC

Control tests is grouped into

Solid Liquid Semi solid Lyophilized Aerosol

Condected to sarisfy product identity, strength, purity and performance and safety Some are performed during processing and repeated in final product

Control test

Test to identify that particular substance is medicine that it claims to be

Identify

Testing method and accepted ranges for the potency of a medicine/drug as fda approval

Strength

Information on impurities

Purity

Preduct and demonstrate how a medicine will be released as it enters the human body

Performance

Preparation for tablets, capsules, powders cakes, sticks

Solid prep.

Measured by ruler or vernier caliper

Thickness

Particle scattering technique

Sieving

# of linear opening per square inch

Mesh #

Retained mesh#20

Coarse granules

Pass #20, retained in #40

Good granules

Pass #20 and 40

Fine granules

Flow characteristics

Angle of repose

<25 Angle of repost

Excellent

25-30 angle of repose

Good

30-40 angle of repose

Fair ( add glidant)

>40 angle of repose

Poor

Static angle of repose

Fixed funnel method Fixed bed cone Tilting box

Methods of angle of repose

Static and kinetic

Untapped volume also known as

Bulk volume

Ratio of the mass of untapped powder

Bulk density

Decrease bulk density after tapped

Tapped density

Other name or carr's index

Compressibility index

Excellent Carr's index

5-13

Good Carr's index

12-16

Fair to passable Carr's index

18-21

Very fluid Carr's index

23-28

Fluid cohesive Carr's index

28-35

Extremely poor, cohesive Carr's index

> 40

Good Hausner's ratio

<1.25

Poor Hausner's ratio

> 1.25

Fair to passable Hausner's ratio

1.25-1.5

High air space

High compressibility

Determining the air spaces

Porosity

High moisture

Sticking and picking

Low moisture

Capping chipping Lamination

Done through microscopic evaluation

Shape of the granules and powders

Hardness equipments

Stokes monsanto - spring Strong cobb - air pump Pfizer - pliers Erweka- susp weight Schleuniger - horizontal

Caused by certain mechanical shock because of materila from intact tablets

Surface erosion

Other name of powder fineness

Sieve analysis/ particle size analysis

Common problems in all manufacturing firm dur to spoilage of active ingredient

Microbial contamination

Minimum test that Need microbial testing

Microbial burden

Causes static build up that cause static charges that dry out the medication affecting the intended behavior

Low humidity

Cause the product to dry out or crumble or stick together

Excess static

Cause the product to absorb excess moisture in the air w/c low comodity

High humidity

Rate limiting test in absorption of the drug

Dissolution

Ability of product to breakdown in small particles or granules

Disintegration

Mixture of active drug and non- drug component and exipient dissolve in suitable solvents or mixtures of solvents

Liquid preparations

Size enlargement process in w/c primary particles clump together to form bigger mass or aglomerate

Agglomeration

Particles immediately set at the bottom part of the container

Suspendibility

Suspended particles of active ingredient should readily redispersed

Redispersibility

Resistance to flow

Viscosity

More than 0.9 of NaCl

Hypertonicity

Less than 0.9% NaCl

Hypotonicity

Instrument in refractive index

Refractometer

Purity determination with direct measurement of liquid measurement based on the refraction of light

Refractive index

Physical property of surface of liquid to resist an external coarse

Surface tension

Fever producing microorganisms

Pyrogen

Key for GMO for safe use

Sterility testing

Dye use in leak test

Methylene blue dye - Destructive methylene blue test

These products are applied topically to steam of mucus membrane such as the eye or face, buccal, nasal mucosa, rectal and vaginal tissues

Semi solid prep.

Test for suppositories

Softening range

State of all of the same kind

Homogeneity

Loss of weight of semi solid drug

Loss of water

Freeze drying

Lyophilized

Process w/c water is removed from the product after it is frozen and placed in a vacuum allowing ice to change directly from solid vapor w/o passing through a liquid phase

Freeze drying

Fast or slow the lyophilized product is dissolved

Rate of solution

Powder tending to form lumps or masses

Caking

Amount of consumable product

Net content

Enough pressure in the package that help product to come out to container

Pressure measurement

Compressed gas inside container in w/c product active ingredient are dispersed

Propellant

Part of package tru w/c product concentrate is expelled in the desired form and rate

Valve

Df composed of a solid or mixture of solids reduced to a finely divided state and intended for internal or external use

Powders

Df composed of dry aggregates of powder particles that may contain one or more APIs w/ or w/o other ingredients

Granules

Granules mesh sieve size range

4-12 mesh sieve size range

The sieves are arranged in nest with the ___ at the top

Coarsest

Maximus angle possible between the surface of a pile of the powder and horizontal planes

Angle of repose

Low angle or repose

Better flow property

Rough and irregular surface

higher angle of repose

Ratio of the mass of untapped powder sample and volume including the contribution of iner particulate void volume

Bulk density

Increased bulk density attained after tapping

Tapped density

Density formula

D=M/V

Angle of repose formula

∅= Tan-1 (h/r)

Demostrate the relationship bet. The flow and compressibility of powder

Carr's index/ compressibility index

Formula for Carr's index

CI = TD-BD/TD x 100

Preducts the flow property of powder by using inter particle friction

Hausner's ratio

HR formula

HR= TD/BD

Determine how many air spaces there are in a powder

Porosity

High porosity

High compressibility

True volume of porosity foluma

D=M/V

Void formula for porositty

Void = BV-TV / BV

Percentage of total volume in porosity

Void

Karl Fisher method

Method 1

Method 2

Azeotropic Distillation/Xylene/toluene method

Gravimetric method

Method 3

Prevents pyridine sulfur complex

Anhydrous methanol

Prevents reversal of action

Pyridine

Solvents in method 2 MC

Xylene and toluene

Used for vegetable drugs Biologics Crude drugs

Method 3

1k in N

9.807 newtons

1kg in G

1000 G

Basket apparatus

Type 1

Tyep 2

Paddle apparatus

Type 3

Reciprocating cylinder

Type 4

Flow through cell apparatus

Cylinder aparatus type

Type 6

Paddle over disk

Type 5

Reciprocating holder

Tyep 7

Unit 5 Flashcards

(150 cards)