MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....elastomeric, plastic components or coatings of the container and closure system when in.....of each facility involved in the manufacturing of the drug substance and excipients should..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

Draft Guidance for Industry: Comparability Protocols — Chemistry,...
...If implementing a change using a comparability protocol calls for a revision of the drug product or drug.....In the past, applicants have used protocols for container closure system changes, and they.....as used in this guidance means drug substance, drug product, intermediate, or in-process material, as..
http://www.fda.gov/cber/gdlns/cmprprot.htm (score=87)

þÿ
...2 The general term product as used in this guidance means drug substance, drug product, intermediate, or in.....In the past, applicants have used protocols for container closure system changes, and they.....facilities saying that a move to a different drug substance or drug product manufacturing site..
http://www.fda.gov/cber/gdlns/cmprprot.pdf (score=84)

...If implementing a change using a comparability protocol calls for a revision of the drug product or drug.....In the past, applicants have used protocols for container closure system changes, and they.....2 The general term product as used in this guidance means drug substance, drug product, intermediate, or in..
http://www.fda.gov/cder/guidance/5427dft.doc (score=84)

þÿ
...2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry.....18 The applicant and/or drug product manufacturer must establish the reliability of the.....A description of the container closure system for the drug substance should be provided..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=78)

þÿ
...2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry.....18 The applicant and/or drug product manufacturer must establish the reliability of the.....A description of the container closure system for the drug substance should be provided..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=76)

Guideline for Submitting Supporting Documentation
...Approval of reprocessing procedures must be obtained before release of the reprocessed drug or drug.....Contract laboratories performing quality control tests on raw materials, drug substance, or the.....Information relating to the container, closure, stability, and labeling are discussed in..
http://www.fda.gov/cder/guidance/drugprod.htm (score=75)

stability guidance -draft
...this guidance to mean a batch of drug substance or drug product manufactured at the scale typically encountered.....The date placed on the container/labels of a drug product designating the time during.....suppliers, container and closure systems, orientations of container during storage, drug..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=74)

Packaging
...If there is a need for interchangeability of container/closure materials for the drug product from one composition or supplier of a.....The IND should describe the packaging and labeling used for the drug substance and the dosage.....It is also possible for a component of the drug product to migrate through the walls of the container, and oxygen, carbon dioxide, or..
http://www.fda.gov/cder/guidance/package.htm (score=67)

Validation of Chromatographic Methods
...both drug substance and drug product.Detection limit is the lowest concentration of analyte in.....and leachables from container and closure or manufacturing process, pesticide in drug.....Solution stability of the drug substance or drug product after preparation..according to the..
http://www.fda.gov/cder/guidance/cmc3.pdf (score=60)

Microsoft Word - 5320.1.doc
...6 ONLY if the drug substance is sterile or if..other product quality microbiology issues are.....Container Closure System..Description of the container-closure system used for the drug.....Description of the Composition of the Drug Product..Description of the drug product composition..
http://www.fda.gov/cder/mapp/5320.1.pdf (score=59)

Q1B Photostability Testing of New Drug Substances and Products
...If testing of the drug product in the immediate container or as marketed is needed, the samples should be placed.....This testing may involve the drug substance alone and/or in simple solutions/suspensions to.....Normally, only one batch of drug substance is tested during the development phase, and then the..
http://www.fda.gov/cder/guidance/1318.htm (score=58)

Microsoft Word - 5020.1.doc
...6 ONLY if the drug substance is sterile or if..other product quality microbiology issues are.....Container Closure System..Description of the container-closure system used for the drug.....Description of the Composition of the Drug Product..Description of the drug product composition..
http://www.fda.gov/cder/mapp/5020.1.pdf (score=57)

Guidance- Content & Format CMC for Vaccine & Related Product
...A list should be provided of all components in the drug product, including drug substance(s)and other ingredients, with.....A description of the container and closure system, and its compatibility with the drug.....trials materials and commercial production batches of drug substance and drug product should be..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=56)

Guidance for Industry Botanical Drug Products
...These regulations require documentation of the drug substance, drug product, placebo, labeling, and an.....A description of the container/closure in which the botanical drug substance is to be.....one in which the components or ingredients and composition of the drug substance and drug product are kept..
http://www.fda.gov/cder/guidance/4592fnl.htm (score=54)

Format and Content for the CMC Section of an Annual Report
...Regulatory specifications and analytical methods for the drug substance and drug..product should be listed.....during the reporting period, including immediate container labels, carton..labeling, and.....Methods for the drug substance and drug product in the format provided. III. SPECIFICATIONS AND METHODS FOR THE..
http://www.fda.gov/cder/guidance/cmc1.pdf (score=54)

...These regulations require documentation of the drug substance, drug product, placebo, labeling, and an.....A description of the container/closure in which the botanical drug substance is to be.....one in which the components or ingredients and composition of the drug substance and drug product are kept..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=52)

GUIDE TO INSPECTIONS OF BULK PHARMACEUTICAL CHEMICALS
...Related substances are defined as those structurally related to a drug substance such as a degradation product or impurities.....container, or is transported without containerization to a location for subsequent.....The USP also notes that the impurity profile of a drug substance is a description of the..
http://www.fda.gov/ora/inspect_ref/igs/bulk.html (score=48)

WAIS Document Retrieval
...Such studies should normally be conducted on the drug product or drug substance containing the degradation.....Product arising from the reaction of a drug substance with an excipient in the drug product or immediate container.....Safety studies should provide a comparison of results of safety testing of the drug product or drug substance..
http://www.fda.gov/cder/guidance/ichq3b.htm (score=47)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...A vehicle that optimally delivers one drug substance may be inappropriate for delivery of a.....Each time a pharmacist removes a sterile product from its original container or reconstitutes a sterile product, a.....Skin temperature and moisture also influence the rate and extent of absorption of the drug..
http://www.fda.gov/cder/fdama/difconc.htm (score=46)

Las Vegas Injury Lawyer