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
