unit 6 Flashcards by Eb Nac

the science, art and technology of enclosing or protecting products for distribution,
storage, sale, and use.

Packaging i

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can be defined as the economical means of providing presentation,
protection, identification, information, convenience, compliance, integrity and stability of the product.

Pharmaceutical packaging

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asses the totality of finish products before reach consumers

Packaging control

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The choice of packaging material will depend upon

The degree of protection required
Compatibility with the dosage form
Customer convenience e.g. size, weight of the dosage form
Filling method
Sterilization method to be employed and cost

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Characteristics of Ideal Packaging Materials

Must protect the preparation from environmental condition
Must not be reactive with the product
Must not impart taste or odors
Non toxic
FDA- approved
Meet applicable tamper resistancy requirements
Adaptable to commonly employed high-speed packaging equipment

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Purpose: to assess the totality of the product before it reaches the consumers

Packaging Control

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process w/c use review or evaluate the entire product w/ its package/ labelling materials to ensure

quality audit

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Reasons for quality audit

Distribution
prevention
correctness
identification

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Ways to prevent mix- ups and errors

clearing
separation
separation
Reconcillation

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quality audit s conducted by

independent specialist

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Emphasize term of quality control

who
cgmp
fda
ich guidelines

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required that only those products that have meet the standards and specs establish in master formula records shall be distrubuted to the market

quality audit

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proceedings to avoid confusion among personnel in change

line clearance

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blend of diverse elements mistake of taking one thing to another

mix-ups

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caused by cross proximity of products apparatus or instrumental used for multiple products can also due to know no proper segregation and storage of products during packaging and repacking.

mix-up and errors

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involve checking w many cntainers, closure and labels were used during the entire packaging

Reconcillation

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various test to ensure that result of important product with comply with specification

Packaging Operational Checklist

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Packaging products

containers
strips
closures
labels
package inserts
printing
accessory product unit

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quality of having uniform structure/ composition

Homogeneity

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used to test integrity of blister pack, package team, small sachets containing tablets

Leakers test

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physical contaminations

firewall and glass particles

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Biological contaminations

microorganism such as bacteria, fungi, viruses

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Chemical contaminations

vapor gasses miosture

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multidose containers that consist of 2 layers provied with perforation, suitable fo conaining single dose of semi solid/ solid preparation

Strips/Pouches

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reagent used in leakers test

Methylene blue

hint that it is opened and expose to environmental factors may cause drug degradation

Torn strip or pouch

Packaging Operational Checklist Products

1. Product mixed with another product 2. Wrong product/ strength 3. Homogeneity 4. Appearance/ color/ odor 5. Contamination with foreign matter 6. Fill/ weight/ volume 7. Heat marks on the product 8. Freedom from chapping, chips, cracks

Packaging Operational Checklist Containers

1. Freedom from cracks or chips 2. Freedom from dents, distortions 3. Contamination with foreign matter 4. Leakage 5. Fill/ weight/ volume

Packaging Operational Checklist Strips/ Pouches

1. Product name/ strength 2. Control code 3. Expiration 4. Rx symbol 5. Leakers in vacuum test 6. Weak seal 7. Empty or wrong count 8. Torn stirp or pouch 9. Freedom from dust or smears 10. Correct cutting 11. Powder in pouches and seals 12. Perforations of tear patches 13. Fill/ weight/ volume

Packaging Operational Checklist Closures

1. Sealing tightness 2. Freedom from dust/smears 3. Crimping 4. Correct design/color

Packaging Operational Checklist Labels

1. Product label/strength 2. Control code 3. Expiration date 4. Rx symbol 5. Registration # 6. Correctness of info 7. Gluing 8. Alignment 9. Torn/soiled 10. Freedom from dust/ smears 11. Missing info/ label

Packaging Operational Checklist Package inserts

1. Incorrect 2. Missing 3. Freedom from dirt/ smears 4. Torn/ soiled 5. Poorly folded/inserted

Packaging Operational Checklist Printing: control code / Exp. Date

1. Incorrect 2. Missing 3. Illegible 4. Mislocation 5. Smeared 6. Skipped printing 7. Misaligned

Packaging Operational Checklist Accessories

1. Missing 2. Mislocation 3. Freedom from dust and smears 4. Defective

Packaging Operational Checklist Product Unit

1. Incorrect packaging 2. Empty packaging 3. Incomplete package content 4. Incorrect counter per unit 5. Incorrect count per displace unit 6. Contamination with foreign material 7. Wrong size 8. Improper assembly of printed materials 9. Improper position of containers 10. Torn packaging component 11. Incorrect count per packs/ shipper 12. Ragged cuts

Finished products pending disposition should be separately stored from finished goods which have been approved by quality control for distribution.

Distribution Control

vulnerable and critical component of a container as far as stability and compatibility is concerned

closure

joining 2 or more process of metal or ductile material to hold the other

crimping

defines the closure, protection and functionality of container while ensuring safety or quality of the drug over the product shelf life

Container-closure system

externals factors that can cause smudging of labels

temperature, moisture, humidity

document included in the package of medication that provide information about the drug and use

Package inserts

automatic product identification and fast recognition and implementation of data

Control code

additional device included in final package form syrups and liquid DF

accessories

products that have accessories

Device packaging

whole unit product

Product unit

result to deficiency in the quality assurance system packaging and helpful with consequences can create problems that may result in drug recalls

bad packaging

prevent release of defective product

CGP and QC

refers to the goods and materials that a business holds for the ultimate purpose of sale and resale

Inventory

Significance of Distribution Control

Time § Uncertainty § Economy

“Just in time” System

Economy

receiving goods only as they are needed in the production process, thereby reducing costs -an inventory strategy companies employ to increase efficiency & decrease waste -items are delivered only when they are needed & used immediately

“Just in time” System

Systems of inventory where the information on the inventory quantity and availability is continuously updated

Perpetual Inventory

Used for relatively inexpensive goods

Periodic Inventory

This system achieves a good control over expensive goods

Perpetual Inventory

System of inventory which is updated on a periodic basis, depending on the manufacturer

Periodic Inventory

contain the following information: a unique stock card no., product name, package size, lot number, expiry date, date received, quantity received & the balance of the stock

Stock Card

contain the following information: a unique stock card no., product name, package size, lot number, expiry date, date received, quantity received & the balance of the stock

Stock Card

given to the distributor once the product has left the manufacturer’s warehouse & a stock transfer number should be indicated on the card

Stock Card

ensure perishable stock and identify by the dates received and moves on to each stage pf production in straight order Stock Card follow

FIFO/FEFO

“Just in time” System risk

out of stock

have more benefits in inventory

Perpetual Inventory

suited with small business inventory

Periodic Inventory

continuous tract of inventory balances

Perpetual Inventory

indicate the beginning and ending inventory w/in a given time period

stock card

aka Lean manufacturing

JIT system

Distribution cards usually contain the following information: a unique distribution number, receiver, product name, package size, lot number, quantity of the product received & expiry date of the product

Distribution Card

Used as an aid to recall of the product when necessary. In both cases of stock & distribution card, it is important that qualified personnel sign the papers.

Distribution Card

encompasses o to manage distribution of product to different pharmaceutical distributors, such as wholesaler and retailers to reach our consumers

Distribution Control

Always present in labels of either primary or secondary It is for every approved products

REGISTRATION #

unit 6 Flashcards

(69 cards)