WEEK 4 (CHAPTER 3) Flashcards
- regulations are established by FDA
- To ensure that minimum standards are met for drug product quality in the US
- this regulations establish requirements for all aspects of pharmaceutical manufacture
- ensure compliance-FDA inspects
CURRENT GOOD MANUFACTURING
PRACTICE (cGMP)
- Requirement for “Current Good Manufacturing Practice
for Finished Pharmaceuticals” - Additional cGMP requirements for biologic products,
medicated articles and medical device
CODE OF FEDERAL REGULATIONS
Contains the minimum requirements for the preparation of finished pharmaceutical product
CGMP FOR FINISHED
PHARMACEUTICALS
-Any component that is intended to furnish pharmacologic activity
Active ingredients
A specific quantity of a drug uniform specified quality produced accdg to a single manufacturing order
Batch
The use of validated in-process sampling and testing methods in such a way that results prove that the process has done what it purports to do for the batch concerned
Batchwise control
Documented testimony by qualified authorities that a system qualification has been performed appropriately
Certification
Determination through inspection in which a manufacturer is acting in accordance to the regulation
Compliance
A finished form that contains active or inactive ingredients
Drug product
Any other component other than the active ingredient in a drug product
Inactive ingredient
Any portion of a batch having uniform specified quality
Lot
Any distinctive combination of letters, numbers, or symbols from which the complete history of the manufacture, processing, packaging, holding, and distribution of a batch or lot of a drug may be determined
Lot number, control number, batch number
provision to all concerned the evidence needed to establish confidence that the activities relating to quality
are performed adequately
Quality assurance
A documented activity performed in accordance with established procedures to ensure compliance
Quality Audit
The regulatory process through which industry measures actual quality performance, compares it with
standards, and acts on the difference
Quality control
an area that is marked, designated or set aside for the holding of incoming components prior to acceptance
testing and qualification for use
Quarantined
concentration of a drug substance per unit dose or volume
Strength
document evidence that a system does what it purports to do
Validation
- documented evidence that a process does what it purports to do
Process validation
- a prospective experimental plan to produce documented evidence that the system has been validated
Validation protocol
Deals with the responsibilities of the quality control unit, employees, and consultants
- All personnel engage in the manufacture required to have the education, training, and experience to fulfill the
assigned responsibility
Organization and Personnel
authority and responsibility for all
functions that may affect product quality
Quality control unit
must be planned for easy cleaning, maintenance, and freedom from congestion and traffic
Buildings
used for the manufacture, processing, packaging, holding, testing, or
control of drug and cosmetics
Equipment
required for production and process controls to ensure that the drug products have the correct identity, strength, quality, and purity
Written procedures
destroyed
Obsolete labels
- Determined by appropriate
stability testing - Assure that a drug product meets
applicable standards of identity,
strength, quality, and purity at the
time of use
Expiration dating
- “one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected
to provide visible evidence to consumers that tampering has occurred”
TAMPER-EVIDENT PACKAGING
important to maintain the physical and chemical stability of the product by being an effective barrier to light, moisture, oxygen, bacteria, volatiles and etc
Packaging
Accdg to USP: holds the article and it may come in direct contact with the article
- must not interact physically or chemically with the drug so as to alter strength, quality or purity
Container
- protects the contents from extraneous solids and loss of the article under ordinary conditions of handling, shipment, storage and distributions.
Well-closed container
- protects the contents from contamination by extraneous liquids, solids, or vapors; from loss of the article under ordinary conditions
Tight container
impervious to air or any other gas under ordinary conditions
Hermetic container
one that holds a quantity of drug intended as a single dose
Single dose container
- hermetic container that permits
withdrawal of successive portions of contents without changing
the strength or endangering the quality or purity
Multiple dose container
- amber glass/opaque
plastics will reduce light transmission
sufficiently to protect a light sensitive product
Light-resistant containers
Highly resistant Borosilicate Glass
SiO2 + B2O3
TYPE I
Treated Soda Lime Glass
Na2O + CaO
SO2 Treatment
TYPE II
Soda Lime Glass for Dry Products
Na2O + CaO
TYPE III
General Purpose Soda Lime Glass
Na2O + CaO
Non parenteral
TYPE NP
High molecular polymers such as Polyethylene, Polystyrene,
Polypropylene, Polyvinyl chloride
Plastic containers
-binding of drug molecule to the
polymer material
Sorption (ab or ad)
- describe the movement of components of a container into the contents
Leaching
binding of molecules to polymer
materials includes both adsorption and absorption.
Sorption
STORAGE
- Freezer: -25ºC and -10ºC
- Cold: Any temperature not exceeding 8ºC
- Cool: 18ºCand 15ºC
- Room temperature: temperature prevailing in a working area
- Controlled Room temp: 20ºC to 25ºC
- Warm: 30ºC and 40ºC
- Excessive Heat: Above 40ºC
