Samaan Pharmaceutics Chp. 3
Any component that is intended to furnish pharmacologic activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body of man or other animals.
Active Ingredient / Active Pharmaceutical Ingredient (API)
Gives a constant real-time update of the process on a series of screens and allows an operator to perform programmed operations at the push of a button.
Advisor 21
Tamper-resistant by design
Aerosol Container
It is during Phase ___ that clinical trials are expected to meet all regulatory requirements.
3
It is during Phase ___ that process optimization is demonstrated to the FDA by the production of at least one tenth of a commercial-size batch.
3
The manufacture of _____ comes under the aegis of cGMP regulations and requirements.
APIs
What does ANDA stand for?
Abbreviated New Drug Applications
The first GMP regulations were under the provisions of the ________ .
Kefauver-Harris Drug Amendments
The requirements for the establishment of and conformance to written specifications, standards, sampling plans, test procedures, and other mechanisms.
Laboratory controls
Provide automation in areas such as sample preparation and handling, wet chemistry procedures, laboratory process control, and instrumental analysis.
Laboratory robotics
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 product may be determined
Lot number, control number, or batch number
record containing the formulation, specifications, manufacturing procedures, quality assurance requirements, and labeling of a finished product
Master records
"The Good Compounding Practices Applicable to State-Licensed Pharmacies" was developed by ________ and it discusses 8 recommendations.
National Association of Boards Pharmacy
What does NDA stand for?
New Drug Applications
What regulations have to be followed to enable thorough cleaning, inspection, and safe & effective use for designed operations?
Occupational Safety and Health Administration regulations
Carton flaps sealed; carton cannot be opened without damage.
Sealed carton
Seal over mouth of tube; must be punctured to reach product
Sealed tube
Band or wrapper shrunk by heat or drying to conform to cap; must be torn to open package
Shrink seal, band
In clinical trial materials, the _______ is different from the commercial scale used in the production of an FDA-approved product
batch size
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 specific batch concerned
batchwise control
while the basic regulations for finished pharmaceuticals apply to biologic products as well, the nature of _________, ______________, and _________ products requires specific mandates.
blood, viral, bacterial
It is during Phase 3 that process _______ is demonstrated to the FDA by the production of at least one tenth of a commercial-size batch.
optimization
_____ is a large-scale production of drugs or drug products for distribution and sale. This was affirmed by provision in the Food and drug Administration Modernization Act.
pharmaceutical manufacturing
documented evidence that a process (e.g. sterilization) does what it purports to do
process validation
During preclinical testing and the early phases of clinical evaluation, a product's formulation and many of the ______ and ______ are under development.
production processes, analytical controls
provision to all concerned the evidence needed to establish confidence that the activities relating to quality are being performed adequately
quality assurance
a 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
the regulatory process through which industry measures actual quality performance, compares it with standards, and acts on the difference
quality control
All materials must be withheld for use in the packaging and labeling of product until approved and released by the _____
quality control unit
an organizational element designated by a firm to be responsible for the duties relating to quality control
quality control unit
The organization and personnel section of the regulations deals with the responsibilities of the _____, ____, and ________
quality control unit, employees, and consultants
an area that is marked, designated, or set aside for the holding of incoming components prior to acceptance testing and qualification for use
quarantine
a sample that accurately portrays the whole
representative sample
the activity whereby the finished product or any of its components is recycled through all or part of the manufacturing process
reprocessing
Drug products that meet specifications may be _________ or ________
salvaged, reprocessed
Expiration dating is determined by appropriate _____ testing
stability
the concentration of the drug substance per unit dose or volume
strength
Examples of in-process samples performed by the quality control laboratory personnel to ensure compliance with all product specifications and batch-to-batch-consistency.
tablet content, dissolution, etc.
Examples of in-process samples performed by production personnel at the time of operation to ensure that the machinery is producing output within preestablished control limits.
tablet size, hardness, etc.
Access to the storage area must be limited to ______
authorized personnel u ain't gettin in k
All records of inspections and controls must be documented in the ________
batch production records
What products are exempt from expiration dating?
homeopathic drug products, allergenic extracts, investigational drugs
any component other than the active ingredients in a drug product
inactive ingredient
a batch or any portion of a batch having uniform specified quality and a distinctive identifying lot number
lot
Returned drug products must be identified by _______ and ______ determined through appropriate testing.
lot number, product quality
Examples of children's medication that are under Current Good Compounding Practices
lozenges, gumdrops, Popsicles, lollipops
Drug products that do not meet specifications will be returned to the _____
marketplace
During Phase 3, the clinical trials are expected to _____
meet all regulatory requirements
Compliance with cGMPs is a critical part of the FDA's preapproval inspection program for_____ and ______
new drug applications (NDAs), abbreviated new drug applications (ANDAs)
The ______ (oldest/youngest) approved stock is distributed first.
oldest
It is during Phase 3 that process optimization is demonstrated to the FDA by the production of at least _______ of a commercial-size batch.
one-tenth
The application of the regulations is focused on all of the defining elements of chemical purity and quality:
(SCHEQASS) (Some Cats Have Even Qualified At Singing Songs) (DON'T JUDGE. YOU CAN MAKE YOUR OWN ACRONYM OK) - Critical chemical reaction steps - Handling of chemical intermediates - Effect of scale-up of chemical batches on the yield - Quality of the water systems - Solvent handling and recovery systems - Analytical methods to detect impurities or chemical residues and the limits set - Stability studies of the bulk pharmaceutical chemical - Specifications and analytical methods for all reactive and nonreactive components used in synthesis
In-process samples are of two general types:
- Those performed by PRODUCTION personnel AT THE TIME OF OPERATION to ensure that the machinery is PRODUCING OUTPUT WITHIN PREESTABLISHED CONTROL LIMITS - Those performed by the QUALITY CONTROL LABORATORY personnel to ensure COMPLIANCE WITH ALL PRODUCT SPECIFICATIONS AND BATCH-TO-BATCH CONSISTENCY
Production, control, and distribution records must be maintained for at least ______ following the expiration date of a production batch.
1 year
True or False: Current Good Manufacturing Practice (cGMP or GMP) regulations are established by the Food, Drug, and Cosmetic Act to ensure that minimum standards are met for drug product quality in the United States. a. True b. False
B, FALSEEEEEEeeeee Answer found: Page 76. cGMP regulations are established by the FDA.
A specific quantity of a drug of uniform specified quality produced according to a single manufacturing order during the same cycle of manufacture.
Batch
Individually sealed dose units; removal requires tearing or breaking individual compartment.
Blister / Strip pack
Paper or foil sealed to mouth of container under cap; must be torn or broken to reach product
Bottle seal
Plastic or metal tear away cap over container; must be broken to remove
Breakable cap
Product and container sealed in plastic, usually mounted on display card; plastic must be cut or broken open to remove product
Bubble Pack
Strip packaging equipment is capable of producing ______ packages per ________. a. 50 packages per second b. 5 packages per minute c. 50 packages per minute d. 5 packages per second.
C, 50 packages per minute. Answer found: page 90, figure 3.5
What does CTM stand for?
Clinical Trial Materials
Thousands of medical devices are regulated by the provisions of the ______
Code of Federal Regulations
What does CFR stand for?
Code of Federal Regulations
any ingredient used in the manufacture of a drug product, including those that may not be present in the finished product
Component
What does cGMP / GMP stand for?
Current Good Manufacturing Practice
____________ regulations are established by the Food and Drug Administration (FDA) to ensure that minimum standards are met for drug product quality in the US.
Current Good Manufacturing Practice (cGMP / GMP)
a finished form that contains an active drug and inactive ingredients. The term may also include a form that does not contain an active ingredient, such as a placebo
Drug product
T/F : Part of the cGMP requirements is that effective deployment of information technologies and automated systems can enhance pharmaceutical process development, production efficiencies, product quality, and regulatory compliance.
FAlllllllllllLLLSeEEEEE this isn't part of the cGMP requirements
GMP regulations are established by the ________ to ensure that minimum standards are met for drug product quality in the U.S
FDA
It is during Phase 3 that process optimization is demonstrated to the _____ by the production of at least one tenth of a commercial-size batch.
FDA
The FDA published initial regulations on tamper-resistant packaging in the ______
Federal Register
Currency and compliance with cGMP regulations are supported through notices in the ______ and through the FDA's ________ and various other guidance issued by the FDA.
Federal Register, Compliance Policy Guide
Sealed around product and/or product container; film must be cut or torn to remove product.
Film Wrapper
The FDA publication of the __________ identifies the inspection program for the manufacture of chemical components of pharmaceutical products to assure that all required standards for quality are met.
Guide to the Inspection of Bulk Pharmaceutical Chemicals
________ has resulted in new approaches to pain management and higher concentrations and combinations of drugs that are now used.
Hospice care
Describes the areas that should be set aside for compounding, either sterile or not. Special attention is required for radiopharmaceuticals and for products requiring special precautions to minimize contamination, such as penicillin.
Subpart: Drug Compounding Facilities
States that equipment used must be of appropriate design, adequate size, and suitably located to facilitate operation for its intended use and for its cleaning and maintenance. If mechanical or electronic equipment is used, controls must be in place to ensure proper performance.
Subpart: Equipment
Discusses the responsibilities of pharmacists and other personnel engaged in compounding. It also stresses that only personnel authorized by the responsible pharmacist shall be in the immediate vicinity of the drug compounding operation.
Subpart: Organization & Personnel
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
Paper or foil sealed over carton flap or bottle cap; must be torn or broken to reach product
Tape seal
As the majority of bulk chemicals (APIs) are synthesized overseas, it is important to confirm their identity and purity and conformance with the ________ and ______ standards prior to use in finished pharmaceuticals.
United States Pharmacopeia (USP), National Formulary (NF)
In the primary tamper-resistant packaging incident, cyanide was surreptitiously placed in _______ capsules in commercial packages
acetaminophen
What does CFR (Code of Federal Regulations) contain?
cGMP for finished pharmaceuticals, additional cGMP requirements for biologic products, medicated articles, medical devices
documented testimony by qualified authorities that a system qualification, calibration, validation, or revalidation has been performed appropriately and that the results are acceptable
certification
As the clinical trials progress from Phase 1 to Phase 2, the processes are being ______ and _____.
characterized & refined
It is during Phase 3 that process optimization is demonstrated to the FDA by the production of at least one-tenth of a ________.
commercial-size batch
determination through inspection of the extent to which a manufacturer is acting in accordance with prescribed regulations, standards, and practices
compliance
______ is professional preparation of prescriptions for specific patients as a part of the traditional practice of pharmacy. This was affirmed by provision in the Food and drug Administration Modernization Act.
compounding
Each label must contain _______ and the _________ or ________ to facilitate product identification
expiration dating, production batch, lot number
What products are exempt from tamper-resistant packaging?
dentifrices, dermatologicals, insulins, throat lozenges
cGMP regulations regulations apply to what three things?
domestic & foreign supplies, and manufacturers
There must be the use of _______ or ____________equipment to conduct a 100% examination for correct labeling during or after completion of finishing operations.
electronic / electromechanical
T/F: Pharmaceutical excipients are components of finished pharmaceutical products and must be produced in accordance with cGMP standards as certified on the application by each sponsor of an NDA or ANDA.
tru
For two-piece hard gelatin capsule products, a minimum of _____ tamper-evident packaging features is required unless the capsules are sealed with tamper-resistant technology.
two dos 2 1+1 2+0 the number of ****s i don't give
documented evidence that a system (e.g. equipment, software, controls) does what it purports to do
validation
A prospective experimental plan to produce documented evidence that the system has been validated.
validation protocol
signed by a second individual or recorded by automated equipment
verified
Most products under the Current Good compounding practices are not available for _______ patients and must be compounded.
veterinary
There must be the use of ________ to conduct a 100% examination for correct labeling during or after completion of finishing operations for hand-applied labeling.
visual inspection
