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Regulatory Class > Regulatory Class - Oct 3 > Flashcards

Regulatory Class - Oct 3 Flashcards

1
Q

Drug Substance

A

the active pharmaceutical ingredient (API); provides the pharmacologic or biologic effect

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2
Q

Drug Product

A

the dosage form that the patients takes, contains inactive ingredients (excipients) and the API

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3
Q

Placebo

A

dosage form that does not contain an API

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4
Q

Label of investigational drugs

A

“Caution: New drug limited by Federal (or US) law to investigational use

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5
Q

CMC Info Required for IND

A

Sufficient info to assure identity, quality, purity, and strength
Final specifications are not expected
Stability data are required at all IND phases to demonstrate that the drug substance and product are within acceptable chemical and physical limites for the duration of the trial

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6
Q

CMC Info Required for Clinical Trial Phases

A

Phase I: identification and control of raw materials and the new drug substance

Phase II: need synthesis procedures, controls, reference standards, specifications, stability data on all Phase I lots

Phase III: need drug substance fully characterized, full manufacturing and controls; need drug product full manufacturing and controls information

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7
Q

Stability data

A

need to make sure that the drug substance or product will last in storage throughout a clinical trial period; especially important if only one batch of the drug is made

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8
Q

CMC Changes during Clinical Trials

A

CMC updates go into IND information amendments

Changes due to scale up manufacturing; improve cost, time efficiency of manufacturing

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9
Q

Validation

A

Documented process verifying that something operates within acceptable and expected limits

Demonstrates that a facility, system, equipment, software, method or process used in the manufacture of a drug operates in a repeatable and reliable manner within predefined parameters of operation

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10
Q

Assay Validation

A

Evaluate accuracy, precision, range, sensitivity, specificity, ruggedness

Need to demonstrate that assay produces reliable results

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11
Q

Manufacturing process validation

A

Assess effect of temperature, time, mixing rate (check variation in)

Need to demonstrate that process produces reproducible material

Need validated assays to do process validation

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12
Q

Facility and equipment validation

A

Evaluate ability to maintain temperature, produce water meeting specifications

Need to demonstrate that facility and equipment function reliably as specified

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13
Q

Cleaning validation

A

Evaluate ability of cleaning procedure and materials to remove residuals from equipment

Need to demonstrate that subsequent batches will not be contaminated by prior batches’ residue

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14
Q

Computer validation

A

Evaluate reliability of computer data storage, data calculations/transformation, collection

Need to demonstrate that computers and associated activities function reliably as specified

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15
Q

NDA: CMC: Drug substance

A

Full description (physical/chemical characteristics and stability)
Name and address of manufacturer
Method of synthesis or isolation and purification
Process controls used during manufacture and packaging
Specifications and analytical methods as necessary to assure identity, strength, quality, purity and bioavailability
Specification relating to stability, sterility, particle size, and crystalline form

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16
Q

NDA: CMC: Drug product

A

List all components used in manufacture
Composition
Specification and analytical methods for each component
Name and address of manufacture(s)
Description of manufacturing and packaging procedures and in-process controls
Specification and analytical methods necessary to assure its identity, strength, quality, purity and bioavailability including specification relating to sterility, dissolution rate, containers and closure systems
Real-time stability data with proposed expiration dating

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17
Q

NDA: CMC: Additional manufacturing information

A

Proposed or actual master batch production record
Specifications and test procedures for each component and the drug product
Names and addresses of sources of drug substance, noncompendial inactive components
Identification of operations performed by each contract facility
Results of any test performed on components used in the manufacture of drug product

18
Q

Environmental Impact

A

Categorical Exclusion: make such a small amount that it won’t affect the environment

Environmental assessment: toxins used or plants or animals needed, or large amounts of toxins produced

19
Q

CMC Issues for Biologics

A

Usually development genetics and expression system and need to validate virus removal

Specific Issues:
Equivalent Methods and Processes
Potency
General Safety
Sterility
Purity
Identity
Constituent Materials
Cultures
20
Q

Current Good Manufacturing Practices (cGMPs)

A

apply to the preparation of drug products for administration to humans or animals (includes biologics)

GLP do not apply to the drug product

21
Q

Quality Control Unit (QCU)

A

Person or organization responsible for the quality control duties

Completely independent of manufacturing organization

Need their own lab space for the testing and approval/rejection of all materials

Responsibilities and procedures must be in writing and they must be followed

QA responsibilities included in QCU

22
Q

QCU Responsibilities

A

Approve or reject all: raw materials, drug product containers & closures, in-process materials, packaging materials, labels and labeling, drug products, procedures/specifications

Responsible for components contracted from other manufacturers (each manufacturer also has their own QCU)

23
Q

cGMPs: Personnel Qualifications

A

People involved in manufacture, processing, packaging, or holding of a drug product must have education/training/experience, or any combination to enable that person to perform the assigned functions.

Qualified individuals must provide cGMP training at appropriate frequency

Adequate personnel required

24
Q

cGMPs: Personnel Responsibilities

A

Wear clean clothing, and protective apparel as necessary to protect drug product from contamination
Use good sanitation/health habits
Enter limited-access areas only if authorized
Those with an illness that may affect drug product are excluded from product contact
Need SOPs to cover these topics

25
Q

cGMPs: Building and Facilities

A

Buildings must be of suitable size, construction and location to facilitate cleaning, maintenance and proper operations
Have adequate space to organize materials and prevent mix-ups
Design flow of materials within facility to prevent contamination
Have a separate or defined areas for various activities

26
Q

cGMPs: Equipment

A

Equipment must be of appropriate design, adequate size and suitably located to facilitate operations for its intended use and for its cleaning and maintenance
Equipment must be constructed, cleaned and maintained appropriately
Equipment must be validated/qualified (need written protocols)

27
Q

Equipment Validation

A

Installation Qualification
Operational Qualification
Performance Qualification

28
Q

cGMPs: Production and Process Controls

A

Written procedures required for production/processing of drug products (approved by QCU)
Deviations from written procedures recorded and justified
In-process sampling and testing
Time limits on production
Control microbiological contamination
Reprocessing of batches that don’t conform to standards or specifications

29
Q

cGMPs: Specifications

A

acceptable limits for what the test results may be

Established for drug product, in-process materials, components, labeling and packaging materials, drug product containers and closures
Include description of sampling and testing procedures used, may reference test procedure
Describe what constitutes conformance to specifications
Describe frequency of retesting

30
Q

cGMPs: Release Testing

A

Test each lot of drug product prior to release for distribution
Testing plans must be in writing (include method of sampling, number of samples to test)
Test (analytical) methods must be validated
Write SOPs for testing and sampling
If lot does not meet specifications, it must be rejected
Rejected lots may be reprocessed and retested

31
Q

cGMPs: Stability Testing

A

Written stability testing program required and must include:
Sample size and test intervals
Storage conditions
Test methods
Use same container/closure system in which drug product is marketed
Test stability of reconstituted products both before and after reconstitution

Need real time stability data to set expiration date

32
Q

General properties of drug substance

A

appearance, melting/boiling points, optical rotation, solubility, pH, and biological activities

33
Q

Conformance to specifications

A

the drug substance, when tested accordingly, will meet the listed acceptance criteria

34
Q

Acceptance Criteria

A

the associated numerical limits, ranges, or other criteria for the tests described

35
Q

Batch analysis

A

collation of analytical data for all the tests included in the specifications

36
Q

Overage

A

a fixed amount of the drug substance in the dosage form that is added in excess of the label claim

37
Q

Compatibility

A

compatibility of drug product with any dilutents or dosage devices specified in labeling; compatibility with coadministered drug products

38
Q

Adulterated Drug

A

if the methods used in or the facilities or controls used for, its manufacture, processing, packaging, or holding do not conform to or are not operated or administered in conformity with cGMPs to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess

39
Q

cGMPs: Process understanding

A

requires the identification of critical sources of variability, the ability to manage variability, and the knowledge that the management of variability will result in a quality product

40
Q

FDA Quality Systems Approach to cGMPs

A

Senior management support
Sufficient resources
Manufacturing operations partnership
Continual self-evaluation

41
Q

Complete List of cGMPs

A 
Personnel
Components (materials)
Procedures
Equipment
Facilities
42
Q

Quality Agreements

A

define quality roles and responsibilities between the contracted company and sponsor

Provides oversight through written agreements

Regulatory Class (12 decks)

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