Glossary of Regulatory and Compliance Terms

This glossary has been compiled by Bruce Berger and reflects the FDA interpretation of terms.

Most definitions have been obtained from the Food Drug and Cosmetic Act, 21 CFR, and guidelines and guidances.

A B C D
E F G H
I J K L
M N O P
Q R S T
U V W X Y Z

A

Act	21 CFR 210.3: Means the Food Drug and Cosmetic Act To see the act, go to Definitions - Operational definitions
Active Ingredient	21 CFR 210.3: Is any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure of any function of the body of man. See also 21 CFR 60.3(b).
Active Moiety	21 CFR 316.39(b)(2): Is the molecule or ion ... responsible for the physiological or pharmacological action of the drug substance.
Actual Yield	21CFR 210.3: Is the quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a particular drug product.
Adequate Directions for Use	21 CFR 201.5 Means directions under which the layman can use a drug safely and for the purposes for which it is intended.
Adolescents	FR Vol. 59, No. 238, Dec. 13, 1994: the age from 12 years to 16 years.
Adverse Drug Experience	21 CFR 314.80(a): Means any adverse event associated with the use of a drug in humans, whether or not considered drug related.
Applicant	21 CFR 314.3: Means any person who submits an application or abbreviated application or an amendment or supplement to them to obtain FDA approval of a new drug or antibiotic drug and any person who owns an approved application or abbreviated application. See also 21 CFR 60.3(b).
Application	21 CFR 314.3: Means the application described under 21 CFR 315.50, including all amendments and supplements to the application. See also 21 CFR 60.3(b).
Approvable Letter	21 CFR 314.3: Means a written communication to an applicant from FDA stating that the agency will approve the application or abbreviated application if specific additional information or material is submitted or specific conditions are met.
Approval Letter	21 CFR 314.3: means a written communication to an applicant from FDA approving an application or an abbreviated application.

B
Batch	MCA Rules and Guidance for Pharmaceutical Manufacturers: A defined quantity of starting material, packaging material or product processed in one process or series of processes so that it could be expected to be homogeneous. See also, 21 CFR 210.3: A specific quantity of drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.
Batch Number	MCA Rules and Guidance for Pharmaceutical Manufacturers: A distinctive combination of numbers and/or letters which specifically identifies a batch.
Bioavailability	21 CFR 320.1(a) Means the rate and extent to which an active ingredient or active moiety is absorbed from the drug product and becomes available at the site of action.
Bioequivalence	21 CFR 320.1(e): Means the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives become available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.

C
Categorical Exclusion	21 CFR 25.15 to 40 CFR 1508: A category of actions which dio not individually or cumulatively have a significant effect on the human environment.
Children	FR Vol. 59, No. 238, Dec. 13, 1994: The age from 2 years to 12 years.
Clinical Investigation	21 CFR 312.3(b): Means any experiment in which a drug is administered or dispensed to, or used, involving, one or more human subjects. See also 21 CFR 60.3(b).
Clinically Superior	21 CFR 316.3(b)(3): Means that a drug is shown to provide a significant therapeutic advantage over and above that provided by an approved orphan drug.
Color Additive	21 CFR 70.3: Is any material not exempted under section 201(t) of the FDCA, that is a dye, pigment, or other substance ... .
Commitment, Stability	Guideline for the Submitting Documentation for the Stability of Human Drugs and Biologics: A statement to conduct prescribed studies on commercial production after approval of an application
Component	21 CFR 210.3: Is any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product.
Contiguous Campus	Guidance Immediate Release Solid Oral Dosage Forms - Scale-up and Post-approval Changes: A continuous or unbroken site or set of buildings in adjacent city blocks.
Contraindications	21 CFR 201.57: Those situations in which the drug should not be used because of the risk of use clearly outweighs any possible benefit.
Control Article	21 CFR 58.3 Means any .. drug or biological product other than a test article that is administered to the test system in the course of a nonclinical laboratory study for the purpose of establishing a basis of comparison with the test article.

D
Debossed	means imprinted with a mark below the dosage form surface. 21 CFR 206.3 - Imprinting of Solid Dosage Form Products
Diluent	21 CFR 70.3: Mean any component of a color additive mixture that is not itself a color additive and has been intentionally mixed to facilitate the use of the mixture ... .
Drug	FDCA 201(g) 1) Articles recognized in the USP, HP or NF; and 2) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and 3) articles (other than food) intended to affect the structure of any function of the body of man or other animals; and 4) articles intended for use as a component of any articles specified in 1), 2), or 3).

Drug Product	21 CFR 210.3(b)(4): A finished dosage form that contains an active ingredient generally, but not necessarily, in association with inactive ingredients. The term also applies to a placebo. See also 21 CFR 314.3 and 320.1(b).
Drug Substance	21 CFR 314.3: Means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease ... .

E
Embossed	means imprinted with a mark raised above the dosage form surface. 21 CFR 206.3 - Imprinting of Solid Dosage Form Products
Emergency Use	21 CFR 56.102: Means the use of a test article on a human subject in a lfe-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time time to obtain institutional review board approval.
Enantiomer	ICH Draft Guideline on Impurities in Drug Substances, FR V.59, No. 183, Sept. 22, 1994: Means compounds with the same molecular formula as the drug substance, which differ in the arrangement of atoms within the molecule and are nonsuperimposable mirror images.
Engraved	means imprinted with a code that is cut into the dosage form surface after it has been completed. 21 CFR 206.3 - Imprinting of Solid Dosage Form Products
Environmental Assessment	21 CFR 25.15 to 40 CFR 1508: A concise public document which provides sufficient evidence for determining whether to prepare an Environmental Impact Statement or a Finding of No Significant Impact.
Environmental Impact Statement	40 CFR 1508: Means a detailed written statment required by section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4321)
Environmental Impact Statement	21 CFR 25.15 to 40 CFR 1508
Expiration Date	Guideline for the Submitting Documentation for the Stability of Human Drugs and Biologics: The date placed on the immediate container label of a product that designates the date through which the product is expected to remain within specifications.
Expiration Dating Period	Guideline for the Submitting Documentation for the Stability of Human Drugs and Biologics: The interval that a drug product is expected to remain within the approved specifications after manufacture.
Extraneous Substance	ICH Draft Guideline on Impurities in Drug Substances, FR V.59, No. 183, Sept. 22, 1994: An impurity arising from any source extraneous to the manufacturing process.

F
Facility	See Institution
Finding of No Significant Impact	21 CFR 25.15 to 40 CFR 1508.17: Finding of No Significant Impact issued by the FDA after the review of an Environmental Assessment briefly presenting the reasons why an environmental impact statement will not be prepared.
FONSI	See Finding of No Significant - a finding made in the review of an NDA's Environmental Assessment. If a FONSI is not issuable, then an applicant must prepare an Environmental Impact Statement.
Formulation	Guidance for Industry Immediate Release Solid Oral Dosage Forms - Scale-up and Post-approval Changes: A listing of the ingredients and composition of the dosage form.

G

H
Human Drug Product	21 CFR 60.3(b): Means the active ingredient of a new drug, antibiotic drug, or human biologic drug, including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient.
Human Subject	21 CFR 56.102: Means an idividual who is or becomes a particpant in research, either as a recipient of the test article or as a control.

I
Identified Impurity	ICH Draft Guideline on Impurities in Drug Substances, FR V.59, No. 183, Sept. 22, 1994: An impurity for which structural characterization has been achieved.
Imprinted	means marked with an identification code by means of debossing, embossing, engraving or printing with ink. 21 CFR 206.3 - Imprinting of Solid Dosage Form Products
Impurity	ICH Draft Guideline on Impurities in Drug Substances, FR V.59, No. 183, Sept. 22, 1994: Any component of the new drug substance which is not the chemical entity defined as the new drug substance.
Impurity Profile	ICH Draft Guideline on Impurities in Drug Substances, FR V.59, No. 183, Sept. 22, 1994: A description of the identified and unidentified impurities present in the new drug substance.
Impurity, Specified	See Specified Impurity.
Impurity, unidentified	See Unidentified Impurity
Inactive ingredient	21 CFR 210.3: Is any component other than the active ingredient. See also 21 CFR 201.117.
Increased Frequency	21 CFR 314.80(a): Mean an increase in the rate of occurrence of a particular adverse drug experience.
Infants	FR, Vol. 59, No. 238, Dec. 12, 1994: the age from 1 month to 2 years.
Injection	Nomenclature and Definitions USP:
	[Drug] Injection Liquid preparations that are the drug substances or solutions thereof
	[Drug] for Injection Dry solids, that, upon the addition of suitable vehicles, yield solutions conforming in all respects to the requirements for injections.
	[Drug] Injectable Emulsion Liquid preparations of drug substances dissolved or dispersed in a suitable emulsion medium.
	[Drug] Injectable Liquid preparations of solids Suspension suspended in a suitable liquid medium.
	[Drug] for Injectable Dry solids, that upon the addition Suspension of suitable vehicles, yield preparations conforming in all rspects to the requirements for Injectable Suspensions.
Ingredient	21 CFR 201.10: The term applies to any substane in a drug, whether added to the formulation as a single substance or in admixture with other substances.
Institution	21 CFR 56.102: Means any public or private entity or agency (synonymous with Facility)
Institutional Review Board	21 CFR 56.102: Means any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects.
Institutional Review Board Approval	21 CFR 56.102: Means the determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional or Federal requirements.
Intermediate	ICH Draft Guideline on Impurities in Drug Substances, FR V.59, No. 183, Sept. 22, 1994: A material produced during steps of the synthesis of a new drug substance which must undergo further molecular change before it becomes a new drug substance.
Interstate Commerce	FDCA 201(b) Commerce between any state ot territory and any place outside thereof.
Investigator	21 CFR 56.102: Means an individual who actually conducts a clinical investigation, or in the event of an investigation performed by a team, is the responsible individual of that team. See also 312.3
Investigational new drug	21 CFR 312.3(b): Means a new drug, antibiotic, or biological drug that is used in a clinical investigation.

J

K

L
Label	FDCA 201(k) A display of written, printed or graphic matter upon the immediate container of any article.
Labeling	FDCA 201(m) - Labeling is all labels and other written, printed, or graphic matter 1) on any article or 2) accompanying any article.
Lake	21 CFR 70.3: Means a straight color extended on a subtratum by adsorption, coprecipitation, or chemical combination that does not include any combination of ingredients made by simple mixing process.
Ligand	ICH Draft Guideline on Impurities in Drug Substances, FR V.59, No. 183, Sept. 22, 1994: An agent, chemical entity, with a strong affinity for a metal ion.
Lot	see Batch

M


Manufacture	MCA Rules and Guidance for Pharmaceutical Manufacturers: All operations of purchase of materials and products, Production, Quality Control, release, storage, distribution of medicinal products and the related controls. See also ICH Draft Guideline on Impurities in Drug Substances, FR V.59, No. 183, Sept. 22, 1994:
Manufacturer	MCA Rules and Guidance for Pharmaceutical Manufacturers: Holder of a Manufacturing Authorization as described in Article 16 of Directive 75/319/EEC. See also, 21 CFR 316.3(b)(8): Means any person or agency engaged in the manufacture of a drug that is subject to investigation and approval under the Act or the biologics provisions of the Public Health Service Act
Manufacturing processing, packing	21 CFR 210.3: Includes the or holding of a drug product packaging and labeling operations, testing and quality control of drug products.
Minimal Risk	21 CFR 56.102: Means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

N
Neonates	FR Vol. 59, No. 238, Dec. 12, 1994: The age from birth to 1 month
New Drug	FDCA 201(p) Any drug which is not generally recognized, among experts qualified by scientific training and experience as safe and effective for use in man. Also see 21 CFR 310.3(h)
New Drug Substance	Guidance Immediate Release Solid Oral Dosage Forms - Scale-up and Post-approval Changes: Any substance that, when used in the manufacturing, processing, or packing of a drug, causes that drug to be a new drug, but does not include intermediates used in the synthesis of such substances. See also 21 CFR 310.3(h), and ICH Draft Guideline on Impurities in Drug Substances, FR V.59, No. 183, Sept. 22, 1994.
Nonprocess Related Error	US vs. Barr, Civil Action 92-1744, 1993: An operator error
Not approvable letter	21 CFR 314.3: Means a written communication to an applicant from FDA stating that the agency does not consider the application or abbreviated application approvable because of one or more deficiencies .. preclude the agency from approving it.

O
Official Compendia	FDCA 201(j) United States Pharmacopoeia (USP), Homeopathic Pharmacopoeia of the United States (HP), National Formulary (NF)
Operating Principle	ICH Draft Guideline on Impurities in Drug Substances, FR V.59, No. 183, Sept. 22, 1994: Rules or concepts governing the operation of the system.
Orphan Drug	21 CFR 316.(b)(10): Means a drug intended for use in a rare disease or condition defined in section 526 of the Act.
Orphan Drug Exclusive Approval	21 CFR 316.(b)(12): Means that, effective on the date of FDA approval as stated in the approval letter of a marketing application for a sponsor of a designated orphan drug, no approval will be given to a subsequent sponsor of the same drug product for the same indication for 7 years.

P
Pediatric Patient/Pediatric	21 CFR 201.57: Defined as the Population pediatric age from birth to 16 year, including age groups often called neonates, infants, children and adolescents.
Percent	21 CFR 201.10: The term, if used without qualifications, means percent on a weight-in-weight basis.
Permeability	Guidance Immediate Release Solid Oral Dosage Forms - Scale-up and Post-approval Changes: The extent of absorption of a drug into the intestinal tract, in the absence of luminal instability..
Pharmaceutical Alternatives	21 CFR 320.1(d): Means drug products that contain the identical therapeutic moiety, or its precursor, but not necessarily in the same amount or dosage form as the same salt or ester.
Pharmaceutical Equivalents	21 CFR 320.1(c): Means drug products that contain identical amounts of the identical active drug ingredient, i.e., the same salt or ester of the same therapeutic moiety, in identical dosage forms but not necessarily containing the same inactive ingredients.
Phase 1 Studies	21 CFR 312.21: Initial introduction of an investigational new drug into humans; Typically closely monitored; May be patients or normal volunteers; designed to determine metabolism and pharmacologic actions of the drug in humans.
Phase 2 Studies	21 CFR 312.21: Controlled clinical studies to demonstrate the effectiveness of the drug for a particular indication in patients with the disease or conditions under study and to determine the common short-teerm side effects and risks associated with the drug. Usually involve no more than several hundred subjects..
Phase 3 Studies	21 CFR 312.21: Expanded controlled and uncontrolled trials. Usually include from several hundred to several thousand subjects.
Pilot Plant Scale	The manufacture of either drug substance or drug product by a procedure fully representative of and simulating that to be applied on a full manufacturing scale. For oral solid dosage forms this is generally taken to be at a minimum scale of one tenth that of full production or 100,000 tablets or capsules, whichever is the larger.
Polymorphism	ICH Draft Guideline on Impurities in Drug Substances, FR V.59, No. 183, Sept. 22, 1994: means the occurrence of different crystalline forms of the same drug substance
Potential Impurity	ICH Draft Guideline on Impurities in Drug Substances, FR V.59, No. 183, Sept. 22, 1994: An impurity which, from theoretical considerations, may arise from or during manufacture. It may or may not actually appear in the new drug substance.
Pregnancy Category A	21 CFR 201.57: A category assigned to a drug if adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy(and there is no evidence of a risk in later trimesters).
Pregnancy Category B	21 CFR 201.57: A category assigned to a drug if reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
Pregnancy Category C	21 CFR 201.57: A category assigned to a drug if reproduction studies have shown an adverse effect on the fetus.
Pregnancy Category D	21 CFR 201.57: A category assigned to a drug if there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in human .. but the potential benifits .. may be acceptable despite its potential risks.

Pregnancy category X	21 CFR 201.57: A category assigned to a drug if studies in animals or humans have demonstrated fetal abnormalities or if there is possible evidence of fetal risk based on adverse reaction reports from investigational or or marketing experience ... and the risk of the use of the drug clearly outweighs any possible benefit.
Process	Guidance Immediate Release Solid Oral Dosage Forms - Scale-up and Post-approval Changes: A series of operations and/or actions used to produce a desired result.
Process-related error	US vs. Barr, Civil Action 92-1744, 1993: A manufacturing error (non-operator)
Production	21 CFR 25.15: Includes manufactur, processing, and packaging operations for FDA-regulated articles that are subject to proposed actions.
Pure Color	21 CFR 70.3: Means the color contained in a color additive, exclusive of any intermediate or other component, or of any diluent, or substratum contained therein.

Q
Qualification, Process	MCA Rules and Guidance for Pharmaceutical Manufacturers: Action proving that any equipment works correctly and actually leads to the expected results.
Qualification, of Impurity	ICH Draft Guideline on Impurities in Drug Substances, FR V.59, No. 183, Sept. 22, 1994: The process of acquiring and evaluating data which establishes the biological safety of an individual impurity or a given impurity profile at the level(s) specified.
Quality Assurance	Pharmaceutical Technology 12/95: An organizational element designated by the company to be responsible for monitoring all aspects of the product quality through a broad systems approach.
Quarantine	Pharmaceutical Technology 12/95: The status or physical isolation of raw materials, intermediates, packaging materials, or drug substances to preclude their use pending a decision on their disposition.

R
Raw Data	21 CFR 56.102: Means any laboratory worksheets, records, memoranda, notes, or exact copies thereof that are the result of original observations.
Reagent	ICH Draft Guideline on Impurities in Drug Substances, FR V.59, No. 183, Sept. 22, 1994: A substance, other than a starting material or solvent, which is used in the manufacture of a new drug substance.
Reprocessing	MCA Rules and Guidance for Pharmaceutical Manufacturers: The reworking of all or part of batch of product of an unacceptable quality from a defined stage of production so that its quality may be rendered acceptable by one or more additional operations.
Representative Sample	21 CFR 210.3: Is a sample that consists of a number of units that are drawn based on rational criteria such as random sampling and intended to assure that the sample accurately portrays the material being sampled.
Retest Date	The date when samples of the drug substance should be reexamined to ensure that material is still suitable for use.
Retest Period	The period of time during which the drug substance can be considered to remain within the specification and therefore acceptable for use in the manufacture of a given drug product, provided that it has been stored under the defined conditions; after this period, the batch should be retested for compliance with specification and then used immediately.

S
Serious	21 CFR 314.80(a): Means an adverse drug experience that is fatal or life-threatening, is permanently disabling, requires inpatient hospitalization, or is congenital anomaly, cancer, or overdose.
Shelf life; Expiration Dating	The time interval that a drug Period product is expected to remain within the approved shelflife specification provided that it is stored under the conditions defined on the label in the proposed containers and closure
Solid oral dosage forms	means capsules, tablets, or similar drug products intended for oral use.
Solvent	ICH Draft Guideline on Impurities in Drug Substances, FR V.59, No. 183, Sept. 22, 1994: An inorganic or organic liquid used as a vehicle for the preparation of solutions or suspensions in the synthesis of a new drug substance.
Specified Impurity	ICH Draft Guideline on Impurities in Drug Substances, FR V.59, No. 183, Sept. 22, 1994: An identified or unidentified impurity that is selected for inclusion in new drug substance specifications and is individually listed and limited in order to assure the safety and quality of the new drug substance.
Specimen	21 CFR 56.102: means any material derived from a test system for examination or analysis.
Sponsor	21 CFR 316.3(b)(14): Means the entity that assumes responsibility for a clinical or nonclinical investigation. A sponsor may be an individual, partnership, corporation, or Government Agency and may be a manufacturer, scientific institution, or investigator regularly and lawfully engaged in the investigation of drugs. See also 21 CFR 310.3(j) and 56.102
Stability	Guideline for the Submitting Documentation for the Stability of Human Drugs and Biologics: The capacity of a drug product to remain within specifications established to ensure its identity, strength, quality, and purity.
Stability Data, Primary	Guideline for the Submitting Documentation for the Stability of Human Drugs and Biologics: Data on the drug product stored in the proposed container-closure for marketing under storage conditions that support the proposed expiration dating period.
Stability Data, Secondary	Guideline for the Submitting Documentation for the Stability of Human Drugs and Biologics: Data other than primary data stability data, such as stability data on investigational formulations not proposed for marketing, accelerated studies on the bulk drug substance, accelerated studies on the proposed drug product for marketing.
Stability Protocol, Approved	Guideline for the Submitting Documentation for the Stability of Human Drugs and Biologics: The detailed plan described in an approved NDA and applied to generate and analyze acceptable stability data in support of the expiration period.
Starting Material	ICH Draft Guideline on Impurities in Drug Substances, FR V.59, No. 183, Sept. 22, 1994: A material used in the synthesis of a new drug substance which is incorporated as an element (building block) in to the structure of an intermediate and/or of the new drug substance. Starting materials are normally commercially available and of defined chemical and physical properties and structure.
Sterility	MCA Rules and Guidance for Pharmaceutical Manufacturers: The absence of living organisms.
Straight Color	21 CFR 70.3: Means a color additive listed in parts 73, 74, and 81 of Chapter I of 21 CFR, and includes lakes and such substances as are permitted by the specificiation for such color..
Strength	21 CFR 210.3: Is the concentration of the drug substance and/or the potency, that is, the therapeutic activity of the drug product as indicated by laboratory tests or adequately developed and controlled clinical data.
Study Completion Date	21 CFR 56.102: Means the date the final report is signed by the study director.
Study Director	21 CFR 56.102: Means the individual responsible for the overall conduct of a nonclinical laboratory study.
Study Initiation Date	21 CFR 56.102: Means the date the protocol is signed by the study director.
Subject	21 CFR 312.3: Means a human who particpates in an investigation, either as a recipient of an investigational new drug or as a control.

T
Test Article	21 CFR 56.102: Means any drug for human use, biological product for human use. See also 21 CFR 58.3.
Test System	21 CFR 56.102: Means any animal, plant, microorganism, or subparts thereof to which the test or control article is administered or added for study.
Testing Facility	21 CFR 56.102: Means a person who actually conducts a nonclinical laboratory study .. and encompasses only those operational units that are being or have been used to conduct nonclinical laboratory studies.
Theoretical Yield	21 CFR 210.3: Is the quantity that would be produced at any appropriate phase of manufacture, processing, or packing of a particular drug product, based upon the quantity of components to be used, in the absence of any loss or error in actual production.
Toxic Impurity	ICH Draft Guideline on Impurities in Drug Substances, FR V.59, No. 183, Sept. 22, 1994: An impurity having significant undesirable biologic activity.
Toxic Substance	21 CFR 25.15: Means any substance that is harmful to some biological mechanism or system.

U
Unexpected	21 CFR 314.80(a): Means as adverse drug experience that is not listed in the current lableing for the drug and includes an event that may be symptomatically or pathophysiologically related to an event listed in the labeling, but differs from the event because of greater severity or specificity.
Unidentified Impurity	ICH Draft Guideline on Impurities in Drug Substances, FR V.59, No. 183, Sept. 22, 1994: An impurity which is defined solely by qualitative analytical properties( e.g., chromatographic retention time.

V
Validation	Pharmaceutical Technology, December 1995: A documented program that provides a high degree of assurance that a specific process, method or system will consistently produce a result meeting predetermined acceptance criteria.
Validated Limit of Quantitation	ICH Draft Guideline on Impurities in Drug Substances, FR V.59, No. 183, Sept. 22, 1994: For impurities at a level of 0.1 percent, the validated limit of quantitation should be less than or equal to 0.05 percent. Impurities limited at higher levels may have higher limits of quantitation.

W
Warnings	21 CFR 201.57: Serious adverse reactions and potential safety hazards, limitations in use imposed by t hem, and steps that should be taken if they occur.

X

Y

Z

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