WAIS Document Retrieval
...Background Persistent problems with drug product mislabeling and subsequent recalls in the late.....Appropriate electronic or electromechanical equipment typically consists of systems that.....drug product, appropriate electronic or electromechanical equipment must be used to conduct a..
http://www.fda.gov/cder/dmpq/frpr7297.htm (score=100)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...Equipment used in the production, processing, or packaging of a PET drug product should be appropriate for the.....Critical activities in the production and testing of a PET drug product that expose the PET drug product or the sterile surface.....The proposed regulation would require the implementation of procedures to ensure that a product is not released until..
http://www.fda.gov/cder/guidance/4259dft.htm (score=99)

...6 And to ensure batch-to-batch consistency 7 of the drug product, appropriate specification for 8 a.....This increases the likelihood for 6 administration of the wrong drug product by the 7 wrong.....And our ultimate goal is to modify the 6 RMP to improve product access for appropriate 7 physicians and..
http://www.fda.gov/ohrms/dockets/ac/04/transcripts/2004-4040T1.DOC (score=96)

MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....discuss significant departures from the approaches outlined in this guidance with the.....establish a set of criteria to which a drug substance or drug product should conform using..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=75)

/a//content.21607
...environmental, public health and safety, and Drug Administration, rm. 1­23, 38 CFR Part 17.....refer to it when using the drug product. recall involves the least serious health threat.....appropriate controls, the use of size, motise@cder.fda.gov). examination for correct..
http://www.fda.gov/cder/dmpq/frpr7297.pdf (score=73)

...In some cases, testing at production stages rather than testing at the finished drug substance or drug product stages may be.....Any component present in the drug substance or drug product that is not the desired product, a product-related.....The comments in the docket will be periodically reviewed, and, where appropriate, the..
http://www.fda.gov/cber/gdlns/ichtest.txt (score=70)

ICH: Guidance on Specifications: Test Procedures and Acceptance Criteria for...
...Cell substrate-derived, employed will vary from product to product, structure of the carbohydrate.....either the drug substance or drug product. product, which may occur during storage, a drug substance should be.....be minimized by the use of appropriate, well- characterization of the product as described..
http://www.fda.gov/cber/gdlns/ichtest.pdf (score=69)

...It is appropriate that the process by which a drug product is manufactured in the development phase be well documented and controlled.....Three comments concerned the proposed exemption of drug product salvagers from drug listing in.....Among the drug products cited as the appropriate measure for current good manufacturing practice were veterinary..
http://www.fda.gov/cder/dmpq/preamble.txt (score=68)

Fresh Air '2000' A look at FDA's Medical Gas Requirements
...Drug product containers and closures play a critical role in assuring that the drug product.....These procedures should include appropriate descriptions of the firm's methods of.....Quarantine areas should be set up to separate the incoming drug product, incoming cylinders and..
http://www.fda.gov/cder/dmpq/freshair.htm (score=64)

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...18 The applicant and/or drug product manufacturer must establish the reliability of the.....apply the content recommendations in this guidance, as scientifically appropriate, and/or.....associated acceptance criteria depend on the route of administration of the drug product and..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=63)

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...18 The applicant and/or drug product manufacturer must establish the reliability of the.....apply the content recommendations in this guidance, as scientifically appropriate, and/or.....associated acceptance criteria depend on the route of administration of the drug product and..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=62)

Guideline for Submitting Supporting Documentation
...The product tests and specifications appropriate to investigational drug products are, understandably, not as well.....Approval of reprocessing procedures must be obtained before release of the reprocessed drug or drug.....State the name, location and, where appropriate, building number of each facility having a..
http://www.fda.gov/cder/guidance/drugprod.htm (score=61)

Guidance for Industry
...In an aseptic process, the drug product, container, and closure are first subjected to.....product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of.....The positive pressure differential should be coupled with appropriate protection at the..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=61)

Sterile Drug Products Produced by Aseptic Processing
...Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design.....Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design.....For each batch of drug product purporting to be sterile and/or pyrogen free, there shall be..
http://www.fda.gov/cder/guidance/5882fnl.htm (score=56)

Guidance for Industry
...In an aseptic process, the drug product, container, and closure are first subjected to.....product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of.....The positive pressure differential should be coupled with appropriate protection at the..
http://www.fda.gov/cder/guidance/1874dft.pdf (score=55)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...ensure that each batch of PET drug product meets its established acceptance criteria, 1201.....errors and ensure that appropriate corrective action is taken to prevent their recurrence.....or lot, of a PET drug typically consists of one multiple-dose vial containing the PET drug..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=54)

Packaging
...It should provide an adequate seal, be compatible with the drug product, and not be a source of.....In these early stages, the IND should also indicate that appropriate stability studies with the appropriate packaging have been.....It is also possible for a component of the drug product to migrate through the walls of the..
http://www.fda.gov/cder/guidance/package.htm (score=52)

stability guidance -draft
...this guidance to mean a batch of drug substance or drug product manufactured at the scale typically encountered.....appropriate for a drug product with respect to the likelihood that such a design would.....appropriate to label the drug product for CRT storage with the proposed expiration dating..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=51)

Guidance for Industry
...ensuring that the drug product provided to the patient has the appropriate identity, strength.....if the condition of the drug product, as a result of storage or shipping, casts doubt on the.....Appropriate controls must be exercised over computer or related systems to ensure that..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0165-gdl0001.pdf (score=51)

6003dft.doc
...changes and that no adverse impact on the quality, safety, or efficacy of the drug product.....identify the appropriate FDA staff, call the appropriate number listed on the title page.....contractual arrangement to produce the intermediates, drug substance, or drug product on..
http://www.fda.gov/cder/guidance/6003dft.pdf (score=49)

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