basic CGMP guidelines for pharmaceutical packaging and labeling

label

a display of written, printed, or graphic matter upon the immediate container or the wrapper of a drug package

labeling

the term that designates all labels and other written, printed, or graphic matter upon an immediate container of an article or upon, or in, any package or wrapper in which it is enclosed except for any outer shipping container

identification of the product, provide ingredients, purpose/use of the product, child safety, provide other patient information

5 functions of pharmaceutical labeling

A.O. 55 s. 1989

pharmaceutical labeling principles; all labels of a drug should conform to the specifications under the FDA rules (___________________________)

labeled in accordance

pharmaceutical labeling principles; that no person sell or distribute any drug unless it is ______________ with the rules

compliance

pharmaceutical labeling principles; ____________ in labeling is achieved if ALL required content is found on the label

brand identification labeling, description labels, promotion, differentiation

4 objectives of pharmaceutical labeling

manufacture label

type of label; a label which contain drug information for the use of medical practitioners, pharmacists, or nurses supplied by the manufacturer, packer, or distributor of the drug

dispensing label

type of label; a label in all dispensed medicine

counterfeiting, safety

pharmaceutical labeling is more complex than ever, with increasing pressure from consumers and regulatory bodies to prevent ___________ and improve ____________

recognized, verified

manufacturers and packaging companies must ensure products can be ____________ and __________ quickly and easily throughout the supply chain, communicating vital information to retailers and distributors

automatic identification and data capture (AIDC) technologies, radio frequency identification (RFID) tags

today's drug manufacturers can choose from a wide selection for labels (2):

container labels, package inserts, patient labeling, medication guides, promotional labeling

all drug labeling, including ___________, ___________, ___________, _____________, ___________, is subject to FDA regulation

office of prescription drug promotion (OPDP)

FDA monitors prescription drug advertising and promotion through the ________________

new drug application (NDA)

no drug can be promoted until the ____________ has been approved by FDA

fair balance

all promotional materials must include a "__________________" of efficacy and risk information

reminder labeling

all promotional materials must include a "fair balance" of efficacy and risk information, with the exception of ______________

boxed warning

reminder labeling is not allowed for products with a _____________

major statement

broadcast advertisements must include a "_____________________" of risk

prescribing information

all non-reminder promotional materials must be accompanied by the full __________________

brief summary

advertisements require an accompanying "___________" of the full prescribing information (FPI)

adequate provision

broadcast advertisements must include "_______________________" for the dissemination of the approved labeling

package insert

a document in the medication package that provides information about that drug and its use

medical professionals

for prescription medications, the package insert is technical, providing information for _____________ about how to prescribe the drug

prescription drug product insert, professional labeling

2 other names for package insert

package insert

provides detailed drug information compiled and distributed by the drug manufacturer after FDA review and approval

2006

year when the standard format for the package insert was changed

user-friendly

in 2006, the standard format for the package insert was changed to make it more _____________ and a more efficient resource tool for practitioners

balanced, misleading

the FDA requires that drug labeling be __________ and not _____________

healthcare practitioners, consumers

the label must be scientifically accurate and provide clear instructions to _______________ for prescription drugs and to ____________ for over-the-counter drugs and supplements

used in the drug

labeling regulations require that the statement of ingredients must include all ingredients in the order in which they are ___________________

users

the safe use of all medicines depends on _________ reading the labeling and packaging carefully and accurately and being able to assimilate and act on the information presented

safe use

all labels must be clear and concise and bear all necessary information regarding the _______ of a product

counterfeit drug

bears an unauthorized representation of a registered trademark on a product identical or similar to one for which the trademark is registered

counterfeit drug

drug that has been falsely labeled regarding its identity and/or origin to fool consumers deliberately

counterfeit drug

drug that does not come from or are not offered in the same form as medicines from the original manufacturer

high, low

examples of counterfeited drugs are medications that: contain the correct active agent, however, either at a dosage that is too ____________ or too ____________

expiration dates

examples of counterfeited drugs are medications that: have manipulated ________________

active

examples of counterfeited drugs are medications that: possesses no _______ agents

active

examples of counterfeited drugs are medications that: contain an __________ agent other than the one specified

forged packaging

examples of counterfeited drugs are medications that: wrapped in ______________, blisters, and/or containing falsified patient information

scratch-off labels

ways to avoid drug counterfeiting: the use of _________________ containing a unique code can be done, which, if texted to a free number, provides a response from the company server, which will assure the product's authenticity

holograms, designs

ways to avoid drug counterfeiting: the use of unique _________ and ________ in labels, which cannot be easily copied

public education, technological solutions

2 strategies to fight counterfeit drugs

role of clinicians, involvement of authorities, social media interventions, telemedicine rather than self-medication/treatment

4 public education strategies to fight counterfeit drugs

visual inspections, anti-tampering packaging, laboratory analysis, non-counterfeitable production methods

4 technological solutions to fight counterfeit drugs

reliable suppliers

role of pharmacists in preventing distribution of counterfeit medications; ensure purchase of medications from known ______________

internet

role of pharmacists in preventing distribution of counterfeit medications; warn patients about the dangers of purchasing medications over the ____________

fraudulent

role of pharmacists in preventing distribution of counterfeit medications; beware of _________ distributors

alerts

role of pharmacists in preventing distribution of counterfeit medications; monitor counterfeit product ______________

faulty

role of pharmacists in preventing distribution of counterfeit medications; inspect all medication packages for __________ seals and labels

medwatch

role of pharmacists in preventing distribution of counterfeit medications; report any suspicious counterfeit medicines through ______________

packaging

economic way of protecting the product from the external environment

packaging

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

packaging

refers to the design, evaluation, and production process of packages

pharmaceutical packaging

the packaging process of any pharmaceutical preparation

pharmaceutical packaging

the economic means of providing presentation, protection, identification, information, convenience, compliance, integrity, and stability of the product

protect society, protect consumers, protect companies

3 intents of pharmaceutical packaging

product identification, product protection, product promotion, product preparation, facilitating the use of product

5 functions of pharmaceutical packaging

container, closure system

2 components of a packaging

primary, secondary, tertiary

3 types of packaging

primary packaging

packaging; the intermediate container of the product has direct contact with the product; thus, it directly affects the product's stability

primary packaging

packaging; the material that first envelops the product and holds it

primary packaging

packaging; usually is the smallest unit of distribution or use

primary packaging

packaging; can also provide a means of directly administering the product

primary packaging

packaging; bottles

primary packaging

packaging; vials

primary packaging

packaging; blister packs

primary packaging

packaging; aerosol can

primary packaging

packaging; pre-filled syringes

secondary packaging

packaging; the material that enclosed one or more primary packaging

outer packaging

other name for secondary packaging

secondary packaging

packaging; used as an additional protection

secondary packaging

packaging; carries the labeling requirements

secondary packaging

packaging; carton

secondary packaging

packaging; corrugated or collapsible box made of paper or board

tertiary packaging

packaging; contains many units of secondary packagnig

tertiary packaging

packaging; used to bulk handling and shipping

protection ability, quantity head, materials used

3 classifications of packaging containers

well-closed

packaging classification according to protection ability; protects from extraneous solids

tight

packaging classification according to protection ability; protects from extraneous solids, liquids, and vapors

tight

packaging classification according to protection ability; protects from efflorescence, deliquescence, and evaporation

hermetic

packaging classification according to protection ability; air-tight, impervious to air or any other gases

parenterals

packaging classification according to protection ability; hermetic example

light-resistant

packaging classification according to protection ability; protects from phytochemical degradation

amber glass, opaque materials

packaging classification according to protection ability; light-resistant example

child-resistant

packaging classification according to protection ability; containers which are difficult for children to open, especially under 5 years old

tamper-resistant

packaging classification according to protection ability; to prevent adulteration of the product

tamper-resistant

packaging classification according to protection ability; it is used as a barrier indicator which if breached or missing can provide evidence that tampering has occurred

single-unit container

packaging classification according to quantity held; holds a single dose only

single-unit container

packaging classification according to quantity held; non-resealable because it is consumed at once

single-unit container

packaging classification according to quantity held; no need to add antimicrobial agents

single-unit container

packaging classification according to quantity held; uses water for injection and sterile water for injection

1000mL/1L (max)

packaging classification according to quantity held; single-unit container USP limit

infusion bag, ampules, pre-filled syringes

packaging classification according to quantity held; single-unit container 3 examples

multiple-unit container

packaging classification according to quantity held; holds more than a single dose

multiple-unit container

packaging classification according to quantity held; resealable because it has to be stored again if there is still left

multiple-unit container

packaging classification according to quantity held; needs antimicrobial agents

multiple-unit container

packaging classification according to quantity held; uses bacteriostatic water for injection

30mL (max)

packaging classification according to quantity held; multiple-unit container USP limit