current good manufacturing practices Flashcards
to ensure that minimum standards are met for drug product quality.
Current Good Manufacturing Practice (cGMP or GMP)
Any component that is intended to furnish pharmacologic activity
Active ingredient or active pharmaceutical ingredient (API)
specific quantity of a drug of uniform specified quality
Batch
prove that the process has done what it purports to do for the specific batch concerned
batchwise control
Documented testimony
Certification
acting in accordance with prescribed regulations, standards, and practices
Compliance
Any ingredient used in the manufacture of a drug product
Component
A finished form that contains an active drug and inactive ingredients.
Drug product
A batch or any portion of a batch having uniform specified quality
Lot
Any distinctive combination of letters, numbers, or symbol
lot number, control number, or batch number
The regulatory process through which industry measures actual quality performance, compares it with standards,
Quality control
documented activity performed in accordance with established procedures on a planned and periodic basis to verify compliance with the procedures to ensure quality
Quality audit
activities relating to quality are being
performed adequately
Quality assurance
A sample that accurately portrays the whole.
Representative sample
Record containing the formulation, specifications, manufacturing procedures, quality assurance requirements, and labeling of a finished product
Master Record
responsible for the duties relating to quality control
Quality control unit
area that is marked, designated, or set aside for the holding of incoming components prior to acceptance
Quarantine
finished product or any of its components
is recycled through all or part of the manufacturing process.
Reprocessing
concentration of the drug substance
Strength
Signed by a second individual
Verified
Documented evidence that a system (e.g., equipment, software, controls) does what it purports to do.
validation
evidence that a process (e.g., sterilization) does what it purports to do
Process Validation
prospective experimental plan to produce documented evidence
Validation Protocol
Deals with the responsibilities of the
quality control unit, employees, and
consultants.
ORGANIZATION AND PERSONNEL
authority and responsibility for all functions
Quality control unit
appropriate design and size and suitably located to facilitate operations
EQUIPMENT
quarantine system to prevent their use in manufacturing and processing operations
Rejected components
enable thorough cleaning, inspection, and safe and effective use for the designated
operations.
Design and Construction Features
In-process controls are of two general types:
Performed by production personnel
Performed by the quality control laboratory
personnel
at the time of operation to ensure that the machinery is producing output within preestablished control limits
Performed by production personnel
to ensure compliance with all product
specifications
Performed by the quality control laboratory
personnel
Each label must contain:
o expiration date
o production batch or lot number
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 PACKAGE
To ensure that a drug product meets applicable standard
EXPIRATION DATE
quarantined in storage until released
Finished pharmaceuticals
maintained for 1 to 3 years after the expiration date of the last lot of the drug product.
Reserve samples
Computers are used extensively in plant operations such as:
o production scheduling,
o in-process manufacturing,
o quality control, and
o packaging and labeling.
must be maintained for at least a year following the expiration date of a product batch.
Production, control, and distribution records
must be identified by lot number and product quality determined through appropriate testing.
Returned drug products
must be produced in compliance with the cGMP regulatory requirements and standardized as to identity, purity, strength, and quality.
Clinical trial materials
regulatory requirements are applied with flexibility.
during preclinical testing
the manufacturer must produce a batch of the drug that is at least one-tenth the size of a commercial batch.
To demonstrate process optimization
customization of a medication to fulfill the precise requirements outlined by the prescriber
Compounding
