MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....An alternative approach may be used if such approach satisfies the requirements of the.....recommended for inclusion in the application regarding the components, manufacturing..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...ensure that each batch of PET drug product meets its established acceptance criteria, 1201.....used if such approach satisfies the requirements of the applicable statutes and.....evaluation can include testing of the material (see Section VI, Control of Components, 276..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=91)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...Critical activities in the production and testing of a PET drug product that expose the PET drug product or the sterile surface.....Large PET centers that handle large numbers of components and PET drug products should.....Equipment used in the production, processing, or packaging of a PET drug product should be..
http://www.fda.gov/cder/guidance/4259dft.htm (score=87)

Guidance for Industry: Human Somatic Cell Therapy and Gene Therapy
...abbreviate testing and IND submission for a product or product series, the sponsor should.....Virus or DNA preparations used as preventive vaccines are not covered by this document.....Murphy, HFM-17, Center for Biologics Evaluation and Research, Food and Drug Administration..
http://www.fda.gov/cber/gdlns/somgene.pdf (score=76)

Substance
...individual batches of the drug substance used in animal and clinical testing, Drug.....relation to the amount of crude product, whether it is filtered while hot, whether a.....Inorganic components used in.. fermentations should meet the same requirements as for..
http://www.fda.gov/cder/guidance/drugsub.pdf (score=74)

Guideline for Submitting Supporting Documentation
...List all substances used in the manufacture of a drug product whether or not they appear in the finished product, and state.....If any proprietary preparations or other mixtures are used as components, their identity should.....List all substances used in the manufacture of a drug product whether or not they appear in the dosage form and state the..
http://www.fda.gov/cder/guidance/drugprod.htm (score=17)

Respi Care Group of Puerto Rico Warning Letter
...Specifically, the aseptic processing area, used in the manufacture of a drug product, does not have suitable construction to.....Failure to establish the reliability of a supplier s analyses of drug components through.....When our investigator requested the certificates of analysis for the components used to manufacture a..
http://www.fda.gov/foi/warning_letters/g5139d.htm (score=8)

Guidance for Industry: Drug Product: Chemistry, Manufacturing, and Controls...
...However, information on other components of the drug product should also be included in section P.4, as.....The composition statement must contain a list of all components used in the manufacture of the drug.....Components that are used in the manufacture of the drug product and do not appear in the finished drug product..
http://www.fda.gov/cber/gdlns/drugcmc.htm (score=7)

CGMP Regulations
...The flow of components, drug product containers, closures, labeling, in-process materials, and drug.....Animals used in testing components, in-process materials, or drug products for compliance.....Such written procedures shall be designed to prevent the contamination of equipment, components, drug..
http://www.fda.gov/cder/dmpq/cgmpregs.htm (score=6)

Drug Master Files Guidance
...A Type II DMF should, in general, be limited to a single drug intermediate, drug substance, drug product, or type of material used.....The names of the suppliers or fabricators of the components used in preparing the.....Drug product means a finished dosage form, for example, tablet, capsule, or solution, that..
http://www.fda.gov/cder/guidance/dmf.htm (score=6)

Chem Revs. of DMFs for DSIs
...and Acceptance Criteria for New Drug Substances and New Drug Products:Chemical Substances International Conference.....Include the status of the materials used in the construction of each packaging component.....If a drug product available for oral use is then submitted as an..ophthalmic product..
http://www.fda.gov/cder/mapp/5015-4.pdf (score=4)

Guidance- PET Drug Products - Current Good Manufacturing Practice (CGMP)
...Critical activities in the production and testing of a PET drug product that expose the PET drug product or the sterile surface.....Equipment used in the production, processing, or packaging of a PET drug product would.....Examine and approve or reject components, containers, closures, in-process materials..
http://www.fda.gov/cder/guidance/5425dft2.htm (score=3)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...The performance of the valve and its compatibility with other drug product components should be.....The specific valve used in each MDI drug product should be carefully selected considering.....If proprietary preparations or other mixtures are used as components, their identity should be..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=3)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...The performance of the valve and its compatibility with other drug product components should be.....The specific valve used in each MDI drug product should be carefully selected considering.....If proprietary preparations or other mixtures are used as components, their identity should be..
http://www.fda.gov/cder/guidance/2180dft.htm (score=3)

Guidance for Industry - On the Content and Format of Chemistry,...
...For the Allergen Patch Test, a description of the ancillary components used to apply the drug product, such as syringes, or.....A list of all components found in the drug product, including the active and other ingredients, with their strengths.....A list of all components used in the propagation and processing of the source material and drug..
http://www.fda.gov/cber/gdlns/cmcaller.htm (score=3)

Issued: 04-23-1999 Guidance for Industry: Content and Format of Chemistry,
...This section should contain information on the final biological drug product including all.....used as components, the information should include a complete statement of composition and.....finished drug product including the sterilization operations, aseptic procedures,lyophilization..
http://www.fda.gov/cber/gdlns/cmcaller.pdf (score=3)

Guidance for Industry: FOR THE SUBMISSION OF CHEMISTRY, MANUFACTURING, AND...
...drug formulation was different from that of the to-be-marketed finished product, data to.....production step, the equipment and materials used,the room or area where the operation is.....A list of all components used in the manufacture..of the drug substance, and their tests..
http://www.fda.gov/cber/gdlns/cmcdna.pdf (score=2)

FR Doc 03-15065
...In that context the FDA's interpretation of drug as meaning drug product is consistent with and indeed required.....In a product-by-process patent, the patented, novel invention is the product and not the process that is used to make the.....components used in the manufacture of the drug product containing the polymorphic form and..
http://www.fda.gov/OHRMS/DOCKETS/98fr/061803a.htm (score=2)

...Raw Materials and Reagents A list of all components used in the manufacture of the drug substance.....Sampling Procedures The sampling procedures for monitoring a batch of finished drug product.....A restriction enzyme digestion map indicating at least those sites used in construction of the final product construct..
http://www.fda.gov/cber/gdlns/cmcdna.txt (score=2)

Quality Systems Approach to Pharmaceutical Current Good Manufacturing...
...For laboratory analysis of the finished drug product, including collection, storage, and.....It may also be useful to manufacturers of components used in the manufacture of these.....In a manufacturing quality systems environment, risk assessment is used as a tool in the development of product specifications..
http://www.fda.gov/cder/guidance/6452dft.htm (score=2)

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