stability guidance -draft
...this guidance to mean a batch of drug substance or drug product manufactured at the scale.....suppliers, container and closure systems, orientations of container during storage, drug.....The date placed on the container/labels of a drug product designating the time during..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=100)

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=88)

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.....In addition, a product filler capable of reproducing an exact fill amount from container to container.....Skin temperature and moisture also influence the rate and extent of absorption of the drug..
http://www.fda.gov/cder/fdama/difconc.htm (score=66)

Microsoft Word - 5320.1.doc
...process and validation information for a sterile drug substance is the same as..for a sterile.....Container Closure System..Description of the container-closure system used for the drug.....Container Closure System..Description of the drug product container closure system [II.A.1..
http://www.fda.gov/cder/mapp/5320.1.pdf (score=45)

Microsoft Word - 5020.1.doc
...process and validation information for a sterile drug substance is the same as..for a sterile.....Container Closure System..Description of the container-closure system used for the drug.....Container Closure System..Description of the drug product container closure system [II.A.1..
http://www.fda.gov/cder/mapp/5020.1.pdf (score=45)

Format and Content for the CMC Section of an Annual Report
...Regulatory specifications and analytical methods for the drug substance and drug..product.....during the reporting period, including immediate container labels, carton..labeling, and.....container and closure system to the original system in accordance..with compendial..
http://www.fda.gov/cder/guidance/cmc1.pdf (score=35)

GUIDE TO INSPECTIONS OF STERILE DRUG SUBSTANCE MANUFACTURERS
...This is particularly important for the foreign sterile bulk drug substance manufacturer where.....Important aspects of the rigid container systems include moisture, particulates and.....In the preparation for a sterile bulk drug substance inspection, a flow chart with the major..
http://www.fda.gov/ora/inspect_ref/igs/subst.html (score=104)

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.....A description of the container and closure system, and its compatibility with the drug..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=74)

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=70)

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...2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry.....A description of the container closure system for the drug substance should be provided.....the suitability of the container closure systems should be provided in S.7.3 and..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=67)

...These regulations require documentation of the drug substance, drug product, placebo, labeling.....A description of the container/closure in which the botanical drug substance is to be.....A copy of the container label and the immediate outer carton label of the marketed product..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=66)

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...2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry.....A description of the container closure system for the drug substance should be provided.....the suitability of the container closure systems should be provided in S.7.3 and..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=65)

Guidance for Industry Botanical Drug Products
...These regulations require documentation of the drug substance, drug product, placebo, labeling.....A description of the container/closure in which the botanical drug substance is to be.....A copy of the container label and the immediate outer carton label of the marketed product..
http://www.fda.gov/cder/guidance/4592fnl.htm (score=64)

Chem Revs. of DMFs for DSIs
...Summarize the data showing that the container/closure system is compatible with the drug.....Include a description and acceptance tests for the container/closure system(s) components.....the bioavailability of the drug products made from the substance, including, for example,specifications relating to..
http://www.fda.gov/cder/mapp/5015-4.pdf (score=57)

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=45)

Guideline for Submitting Supporting Documentation
...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.....An assay method including adequate acceptance specifications for content of the new drug..
http://www.fda.gov/cder/guidance/drugprod.htm (score=38)

Q1B Photostability Testing of New Drug Substances and Products
...This testing may involve the drug substance alone and/or in simple solutions/suspensions to.....If testing of the drug product in the immediate container or as marketed is needed, the samples should be placed.....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=38)

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..
http://www.fda.gov/cber/gdlns/cmprprot.htm (score=34)

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...2 The general term product as used in this guidance means drug substance, drug product.....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=34)

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...drug substances or drug products derived from plants, animals, or microorganisms(section.....semi-synthetic process as well as a drug substance or drug product derived directly..from these.....a new container closure system, and the container closure system is already approved..in the NDA or ANDA for other strengths..
http://www.fda.gov/cder/guidance/4163fnl.pdf (score=33)

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