Sterile Drug Products Produced by Aseptic Processing
...Any manual or mechanical manipulation of the sterilized drug, components, containers, or.....In an aseptic process, the drug product, container, and closure are first subjected to sterilization.....Drug product components, containers, closures, storage time limitations, and manufacturing equipment..
http://www.fda.gov/cder/guidance/5882fnl.htm (score=100)

Guidance for Industry
...products shall be excluded from direct contact with components, drug product containers, closures, in.....also require appropriate retesting of any component, drug product container, or closure that is subject.....prevent the contamination of equipment, components, drug product containers, closures..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=71)

Guidance for Industry
...products shall be excluded from direct contact with components, drug product containers, closures, in.....also require appropriate retesting of any component, drug product container, or closure that is subject.....prevent the contamination of equipment, components, drug product containers, closures..
http://www.fda.gov/cder/guidance/1874dft.pdf (score=71)

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.....evaluation can include testing of the material (see Section VI, Control of Components, 276..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=43)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...Large PET centers that handle large numbers of components and PET drug products should organize their.....Container assemblies should be prepared at the beginning of the day before other daily.....Equipment would have to be constructed so that surfaces that contact components, in-process materials, or drug products are not..
http://www.fda.gov/cder/guidance/4259dft.htm (score=42)

Packaging
...If a medicine dropper is incorporated as an integral part of the drug container or closure.....The components for the closure and the closure design should be selected with due.....If there is a need for interchangeability of container/closure materials for the drug product from one composition or supplier..
http://www.fda.gov/cder/guidance/package.htm (score=22)

MDI and DPI Drug Products
...Documentation in Drug Applications for Container and Closure Systems Used for the.....elastomeric, plastic components or coatings of the container and closure system when in.....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=16)

CGMP Regulations
...Accelerated studies, combined with basic stability information on the components, drug products, and container-closure.....The flow of components, drug product containers, closures, labeling, in-process materials, and drug.....Such procedures shall also require appropriate retesting of any component, drug product container, or..
http://www.fda.gov/cder/dmpq/cgmpregs.htm (score=212)

Questions and Answers on Current Good Manufacturing Practices, Good...
...For container/closures purporting to be sterile or depyrogenated, sampling should be under.....Generally, we believe that sampling in a typical drug manufacturing facility warehouse.....Testing and approval or rejection of components, drug product container, and closures..
http://www.fda.gov/cder/guidance/cGMPs/production.htm (score=97)

GUIDE TO INSPECTIONS OF DOSAGE FORM DRUG MANUFACTURER'S - CGMPR'S
...Determine the validity, and accuracy of the firm's inventory system for drug components.....The label should identify the contents of the container or equipment including the batch.....Components must be handled in accordance with the drug CGMP's including components used in the research and..
http://www.fda.gov/ora/inspect_ref/igs/dose.html (score=42)

HUMAN DRUG CGMP NOTES March 1998
...Likewise, microorganisms that react with, or potentially damage the integrity of, the.....Is the employment of HIV infected workers in drug manufacturing facilities in conformance.....components, drug product containers, closures, in-process materials, and drug products..
http://www.fda.gov/cder/hdn/cnotes38.htm (score=42)

Microsoft Word - CNOTES vol 2 no 3 sep 94.doc
...labeling other than immediate container labels, effective date of the new labeling control.....the drug product, the quantities are in the parts-per-million range. This does not mean.....August 3, 1994 for immediate container labels, assess the availability of equipment..
http://www.fda.gov/cder/dmpq/CNOTES%20vol%202%20no%203%20sep%2094.pdf (score=40)

Guidance For the Submission of Documentation for Sterilization Process
...The sensitivity of the experimental method used for container-closure integrity testing.....other processes should be addressed as each applies to the drug product,sterile packaging.....The sterilization and depyrogenation processes used for containers,closures, equipment..
http://www.fda.gov/cber/gdlns/sterval.pdf (score=40)

Draft Guidance for Industry and FDA Review Staff: Collection of Platelets by...
...This draft guidance applies only to Platelets, Pheresis components collected by automated.....components, drug product containers, closures, in-process materials, labeling, and drug products.....container; platelet concentration per uL in the storage container, or target platelet..
http://www.fda.gov/cber/gdlns/plateletauto.htm (score=40)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...The design, composition, and quality control of the individual components of the container closure are key.....For plastic components, there is the potential for drug adsorption into the plastic, swelling of the plastic, and leaching of.....These components affect the release rate of the drug and the adherence of the device to the skin and, therefore, have a large impact..
http://www.fda.gov/cder/fdama/difconc.htm (score=14)

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