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