unit 6 Flashcards
the science, art and technology of enclosing or protecting products for distribution,
storage, sale, and use.
Packaging i
can be defined as the economical means of providing presentation,
protection, identification, information, convenience, compliance, integrity and stability of the product.
Pharmaceutical packaging
asses the totality of finish products before reach consumers
Packaging control
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
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
Purpose: to assess the totality of the product before it reaches the consumers
Packaging Control
process w/c use review or evaluate the entire product w/ its package/ labelling materials to ensure
quality audit
Reasons for quality audit
Distribution
prevention
correctness
identification
Ways to prevent mix- ups and errors
clearing
separation
separation
Reconcillation
quality audit s conducted by
independent specialist
Emphasize term of quality control
who
cgmp
fda
ich guidelines
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
proceedings to avoid confusion among personnel in change
line clearance
blend of diverse elements mistake of taking one thing to another
mix-ups
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
involve checking w many cntainers, closure and labels were used during the entire packaging
Reconcillation
various test to ensure that result of important product with comply with specification
Packaging Operational Checklist
Packaging products
containers
strips
closures
labels
package inserts
printing
accessory product unit
quality of having uniform structure/ composition
Homogeneity
used to test integrity of blister pack, package team, small sachets containing tablets
Leakers test
physical contaminations
firewall and glass particles
Biological contaminations
microorganism such as bacteria, fungi, viruses
Chemical contaminations
vapor gasses miosture
multidose containers that consist of 2 layers provied with perforation, suitable fo conaining single dose of semi solid/ solid preparation
Strips/Pouches
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
- Product mixed with another product
- Wrong product/ strength
- Homogeneity
- Appearance/ color/ odor
- Contamination with foreign matter
- Fill/ weight/ volume
- Heat marks on the product
- Freedom from chapping, chips, cracks
Packaging Operational Checklist Containers
- Freedom from cracks or chips
- Freedom from dents, distortions
- Contamination with foreign matter
- Leakage
- Fill/ weight/ volume
Packaging Operational Checklist Strips/ Pouches
- Product name/ strength
- Control code
- Expiration
- Rx symbol
- Leakers in vacuum test
- Weak seal
- Empty or wrong count
- Torn stirp or pouch
- Freedom from dust or smears
- Correct cutting
- Powder in pouches and seals
- Perforations of tear patches
- Fill/ weight/ volume
Packaging Operational Checklist Closures
- Sealing tightness
- Freedom from dust/smears
- Crimping
- Correct design/color
Packaging Operational Checklist Labels
- Product label/strength
- Control code
- Expiration date
- Rx symbol
- Registration #
- Correctness of info
- Gluing
- Alignment
- Torn/soiled
- Freedom from dust/ smears
- Missing info/ label
Packaging Operational Checklist Package inserts
- Incorrect
- Missing
- Freedom from dirt/ smears
- Torn/ soiled
- Poorly folded/inserted
Packaging Operational Checklist Printing: control code / Exp. Date
- Incorrect
- Missing
- Illegible
- Mislocation
- Smeared
- Skipped printing
- Misaligned
Packaging Operational Checklist Accessories
- Missing
- Mislocation
- Freedom from dust and smears
- Defective
Packaging Operational Checklist Product Unit
- Incorrect packaging
- Empty packaging
- Incomplete package content
- Incorrect counter per unit
- Incorrect count per displace unit
- Contamination with foreign material
- Wrong size
- Improper assembly of printed materials
- Improper position of containers
- Torn packaging component
- Incorrect count per packs/ shipper
- 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 #
