MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....elastomeric, plastic components or coatings of the container and closure system when in.....Documentation in Drug Applications for Container and Closure Systems Used for the..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

Review - Laronidase (Aldurazyme)
...The analytical methods used to evaluate the quality attributes of the final container drug.....final container drug product is requested for 24 months stored at 2­8oC. Expiration dating will be.....adequate segregation of drug product final containers and adequacy of controls. Drug product..
http://www.fda.gov/cder/biologics/review/larobio043003r4.pdf (score=89)

Guidance for Industry
...also require appropriate retesting of any component, drug product container, or closure that is subject.....In an aseptic process, the drug product, container, and closure are first subjected to.....terminally sterilized drug product, on the other hand, undergoes a single sterilization process..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=80)

Guidance for Industry
...also require appropriate retesting of any component, drug product container, or closure that is subject.....In an aseptic process, the drug product, container, and closure are first subjected to.....terminally sterilized drug product, on the other hand, undergoes a single sterilization process..
http://www.fda.gov/cder/guidance/1874dft.pdf (score=73)

Sterile Drug Products Produced by Aseptic Processing
...In an aseptic process, the drug product, container, and closure are first subjected to sterilization.....The sterile drug product and its container-closures should be protected by equipment of.....Drug product containers and closures shall be clean and, where indicated by the nature of the..
http://www.fda.gov/cder/guidance/5882fnl.htm (score=72)

Packaging
...If there is a need for interchangeability of container/closure materials for the drug product from one composition or supplier of a.....It is also possible for a component of the drug product to migrate through the walls of the.....If they do, adequate information to justify the use of the container system in combination with the drug product should be..
http://www.fda.gov/cder/guidance/package.htm (score=71)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...ensure that each batch of PET drug product meets its established acceptance criteria, 1201.....made to verify that the correct label has been affixed to the container and the shield.....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=70)

WAIS Document Retrieval
...Background Persistent problems with drug product mislabeling and subsequent recalls in the late.....FDA is proposing to limit the scope of the cut labeling provision to immediate container.....container in which a drug product is commonly marketed at retail and many consumers read this labeling when..
http://www.fda.gov/cder/dmpq/frpr7297.htm (score=69)

Guidance for Industry
...ensuring that the drug product provided to the patient has the appropriate identity, strength.....oxygen container, installed it on the argon container, and connected the deadly product to.....if the condition of the drug product, as a result of storage or shipping, casts doubt on the..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0165-gdl0001.pdf (score=68)

stability guidance -draft
...If testing of the drug product in the immediate container or as marketed is needed, the samples.....Stability data should be developed for the drug product in each type of immediate container and.....this guidance to mean a batch of drug substance or drug product manufactured at the scale typically encountered..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=68)

...This increases the likelihood for 6 administration of the wrong drug product by the 7 wrong.....area, fills 2 the container, and it withdraws, and then the 3 container is sealed and.....This method will 7 protect the drug product from contamination from 8 the environment and..
http://www.fda.gov/ohrms/dockets/ac/04/transcripts/2004-4040T1.DOC (score=66)

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.....Container assemblies should be prepared at the beginning of the day before other daily.....A batch of a PET drug product is a predefined quantity of the drug that has been produced to..
http://www.fda.gov/cder/guidance/4259dft.htm (score=65)

þÿ
...system components are critical to ensure the quality and purity of the drug product and must be.....packaged in semipermeable primary container closure systems, such as low-density.....environment, particularly the secondary packaging, can react with the drug product to form..
http://www.fda.gov/cder/guidance/4168dft.pdf (score=64)

Compressed Medical Gases Guideline, 2/89 (cmgg89.htm)
...Specifications and testing procedures for CMG drug product container/closure systems should include the.....63 requires that equipment used in the manufacture, processing, packing, or holding of a drug.....For instance, a previous container label may be left on when the container is refilled, and the label need not be replaced unless..
http://www.fda.gov/cder/guidance/cmgg89.htm (score=59)

Microsoft Word - 5320.1.doc
...Description of the Composition of the Drug Product..Description of the drug product composition.....Container Closure System..Description of the container-closure system used for the drug.....References to the corresponding drug product..sections of the CTD-Q and a reference to the ICH..
http://www.fda.gov/cder/mapp/5320.1.pdf (score=58)

Applications for Parenteral Products Packaged in Plastic Immed
...parenteral drug product packaged in a plastic immediate container is a new drug under..section.....An application for approval of a parenteral product in a plastic immediate..container for which the container requires.....This MAPP describes the types of new drug application that will satisfy the..requirements..
http://www.fda.gov/cder/mapp/6020-2.pdf (score=56)

Microsoft Word - 5020.1.doc
...Description of the Composition of the Drug Product..Description of the drug product composition.....Container Closure System..Description of the container-closure system used for the drug.....References to the corresponding drug product..sections of the CTD-Q and a reference to the ICH..
http://www.fda.gov/cder/mapp/5020.1.pdf (score=56)

Guidance on the Packaging of Test Batches
...table of packaging information describing the container/closure system,the total number of.....For liquids, the total amount of bulk product packaged should be,at a minimum, 10 percent.....validation studies are conducted prior to the marketing of a drug product to assure..that..
http://www.fda.gov/cder/mapp/5225-1.pdf (score=56)

...Three comments concerned the proposed exemption of drug product salvagers from drug listing in.....container should not be a part of the regulations at this time, and this requirement is.....He does not agree that drug product salvaging should be prohibited where the integrity of the..
http://www.fda.gov/cder/dmpq/preamble.txt (score=88)

Fresh Air '2000' A look at FDA's Medical Gas Requirements
...Finally, a finished drug product odor test must be performed on each container undergoing.....Drug product containers and closures play a critical role in assuring that the drug product.....This would pertain to any container or closure used to deliver industrial products, any..
http://www.fda.gov/cder/dmpq/freshair.htm (score=83)

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