Review - Laronidase (Aldurazyme)
...The analytical methods used to evaluate the quality attributes of the final container drug.....Please provide information which confirms that the assays used for release testing of drug.....final container drug product is requested for 24 months stored at 2­8oC. Expiration dating..
http://www.fda.gov/cder/biologics/review/larobio043003r4.pdf (score=100)

Packaging
...If a medicine dropper is incorporated as an integral part of the drug container or closure.....If there is a need for interchangeability of container/closure materials for the drug product from one composition or supplier.....Samples of a drug that are selected for stability studies should be packaged in the container/clsoure system in which the drug..
http://www.fda.gov/cder/guidance/package.htm (score=37)

MDI and DPI Drug Products
...Documentation in Drug Applications for Container and Closure Systems Used for the.....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..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=37)

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...drug products can and has occurred as a result of entry through LDPE container closure.....packaged in semipermeable primary container closure systems, such as low-density.....adequate acceptance criteria to ensure that batches of drug products meet each appropriate..
http://www.fda.gov/cder/guidance/4168dft.pdf (score=36)

WAIS Document Retrieval
...FDA is proposing to limit the scope of the cut labeling provision to immediate container.....Background Persistent problems with drug product mislabeling and subsequent recalls in the.....If cut labeling is used for immediate container labels, individual unit cartons, or..
http://www.fda.gov/cder/dmpq/frpr7297.htm (score=36)

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.....The sterile drug product and container closures should be protected by equipment of..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=36)

Guidance for Industry
...container and attached it to the container containing argon, and was able to fill the.....adverse drug experience, which is required to be reported to the Food and Drug.....oxygen container, installed it on the argon container, and connected the deadly product to..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0165-gdl0001.pdf (score=36)

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.....The sterile drug product and container closures should be protected by equipment of..
http://www.fda.gov/cder/guidance/1874dft.pdf (score=35)

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.....container and closure system to the original system in accordance..with compendial..
http://www.fda.gov/cder/guidance/cmc1.pdf (score=35)

HUMAN DRUG CGMP NOTES June 2000
...These include guidance documents pertaining to stability testing and container-closure.....What FDA guidance documents pertain to drug repackaging operations and how can they be.....Just as the container-closure system chosen by a firm needs to be a robust one to ensure..
http://www.fda.gov/cder/hdn/cnotes0600.htm (score=35)

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.....In most cases, the product, container, and closure have low bioburden, but they are not..
http://www.fda.gov/cder/guidance/5882fnl.htm (score=35)

HUMAN DRUG CGMP NOTES, June 1997
...Except for large containers, a random sample should be collected from an unopened.....Welcome to another edition of Human Drug CGMP Notes, our periodic memo on CGMP for human.....in other parts of the container, it may be necessary to collect separately identified..
http://www.fda.gov/cder/hdn/cnotes67.htm (score=34)

National Uniformity for Nonprecription Drugs, Ingredient Listing for OTC Drugs
...If the drug is an OTC drug that is not a cosmetic-drug, then the inactive ingredients must be listed in.....established name of each inactive ingredient on the outside container of the retail.....determined to be appropriate by the Secretary, on the immediate container as well, as..
http://www.fda.gov/cder/guidance/2219fnl.pdf (score=34)

Applications for Parenteral Products Packaged in Plastic Immed
...parenteral drug product packaged in a plastic immediate container is a new drug under.....container for which there is no reference listed drug, should be filed as an NDA..under.....container for which the container requires animal studies beyond limited..confirmatory testing and the testing..
http://www.fda.gov/cder/mapp/6020-2.pdf (score=34)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...or lot, of a PET drug typically consists of one multiple-dose vial containing the PET drug.....made to verify that the correct label has been affixed to the container and the shield.....1 This guidance has been prepared by the PET Steering Committee in the Center for Drug..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=33)

Compliance Policy Guides: Radiofrequency Identification Feasibility Studies...
...4Writing to a tag before it is affixed to a container increases the risk of product mix.....Drug Application.2 The study need not have a pre-determined time limit or endpoint, except.....read-write tags"), or after the tag is affixed to a drug's container.4 The tags will contain a..
http://www.fda.gov/oc/initiatives/counterfeit/rfid_cpg.html (score=33)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...When the receiving facility disposes of the recalled drug, the PET drug producer should obtain a signed.....Container assemblies should be prepared at the beginning of the day before other daily.....Critical activities in the production and testing of a PET drug product that expose the PET drug product or the sterile..
http://www.fda.gov/cder/guidance/4259dft.htm (score=33)

Guidance on the Packaging of Test Batches
...table of packaging information describing the container/closure system,the total number of.....Test batches prepared for New Drug..Applications, which are reviewed by the Offices of.....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=33)

Document
...using both public and private funds, their drug or biologic. FDA has, to date, Drug.....wrapper is also the only container or .. Todd A. Stevenson, other designation that relates.....pediatric studies of the drug or biologic, products for which the manufacturers .. studies..
http://www.fda.gov/OHRMS/DOCKETS/98fr/042402a.pdf (score=33)

Drg00201
...A solid dosage form in which the drug is enclosed within either a hard or soft soluble.....A solid dosage form in which the drug is enclosed within either a hard or soft soluble.....A solid dosage form in which the drug is enclosed within either a hard or soft soluble..
http://www.fda.gov/cder/dsm/DRG/drg00201.htm (score=33)

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