þÿ
...This document provides questions and answers relating to the guidance on Container Closure.....Information on container closure systems used for storage of bulk drug products,other than.....B of the guidance states that container closure systems for on-site storage..have..
http://www.fda.gov/cder/guidance/4828fnl.PDF (score=100)

Acidified food manufacturers
...Are container examinations made as per the container manufacturer specifications and or.....Another example is improper container closure resulting in contamination with.....However, the lack of control of container integrity by itself is not always sufficient..
http://www.fda.gov/ora/inspect_ref/igs/acidfgde.htm (score=98)

Guidanc for Industry: Container and Closure Integrity Testing in Lieu of...
...than sterility testing to confirm container and closure integrity as a part of stability.....test with an appropriate container and closure integrity test in the stability protocol.....methods available may more reliably confirm the integrity of the container and closure..
http://www.fda.gov/cber/gdlns/contain.pdf (score=94)

Guidance for Industry: Container Closure Systems for Packaging Human Drugs...
...This document provides questions and answers relating to the guidance on Container Closure.....Information on container closure systems used for storage of bulk drug products,other than.....B of the guidance states that container closure systems for on-site storage..have..
http://www.fda.gov/cber/gdlns/cntanrq&a.pdf (score=101)

Consistent Container Information in an Abbreviated Application
...The stability section only describes the container as made from"HDPE resin with a metal.....To ensure that generic drug firms provide consistent descriptions of container..information in the stability and container/closure.....section on the container/closure system, in which information regarding the..manufacture..
http://www.fda.gov/cder/mapp/5225-2.pdf (score=97)

Packaging
...A suitable closure is an essential part of the container/closure system required to.....Thus, the container characteristics and tests and specifications are reviewed in the.....If a medicine dropper is incorporated as an integral part of the drug container or closure..
http://www.fda.gov/cder/guidance/package.htm (score=96)

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.....container and closure system as a result of direct contact with the formulation of the MDI..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=96)

...area, fills 2 the container, and it withdraws, and then the 3 container is sealed and.....Often there is very little on the 2 container itself to help people distinguish these 3.....18 Timoptic OCUDOSE is an example of an 19 ophthalmic solution packaged in an LDPE..
http://www.fda.gov/ohrms/dockets/ac/04/transcripts/2004-4040T1.DOC (score=94)

Guidance for Industry
...container and attached it to the container containing argon, and was able to fill the.....oxygen container, installed it on the argon container, and connected the deadly product to.....removed a fitting from an empty oxygen container and installed it on the nitrogen..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0165-gdl0001.pdf (score=94)

Guidance for Industry
...In an aseptic process, the drug product, container, and closure are first subjected to.....sterilize the product in its final container, it is critical that containers be filled and.....This area is critical because the product is not processed further in its immediate..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=93)

stability guidance -draft
...retest date should be placed on the storage container and on the shipping container for a.....the same formulation of the dosage form in the container and closure proposed for.....shorter expiration dating period, refrigerator temperature storage, more protective..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=92)

Guidance for Industry
...In an aseptic process, the drug product, container, and closure are first subjected to.....sterilize the product in its final container, it is critical that containers be filled and.....This area is critical because the product is not processed further in its immediate..
http://www.fda.gov/cder/guidance/1874dft.pdf (score=92)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...In addition, a product filler capable of reproducing an exact fill amount from container to container.....In MDI products, the container closure system consists of the container, the valve and its components, the actuator, additional.....Each time a pharmacist removes a sterile product from its original container or..
http://www.fda.gov/cder/fdama/difconc.htm (score=92)

þÿ
...packaged in semipermeable primary container closure systems, such as low-density.....formulation components or leaching from the container closure system, chemical impurities.....drug products can and has occurred as a result of entry through LDPE container closure..
http://www.fda.gov/cder/guidance/4168dft.pdf (score=91)

...ARE CONTAINER HANDLING PROCEDURES AND CONVEYANCE EQUIPMENT ADEQUATE TO | |58 |PROTECT THE.....EMPTY CONTAINER INTEGRITY | |25 |DESCRIBE THE CONTAINERS BEING USED DURING THIS INSPECTION.....DOES THE FIRM HAVE WRITTEN CRITERIA TO ACCEPT OR REJECT INCOMING EMPTY | |27 |CONTAINER..
http://www.fda.gov/opacom/morechoices/fdaforms/FDA3511.DOC (score=90)

Format and Content for the CMC Section of an Annual Report
...during the reporting period, including immediate container labels, carton..labeling, and.....container and closure system to the original system in accordance..with compendial.....changed container and closure system in stability studies using the..approved stability..
http://www.fda.gov/cder/guidance/cmc1.pdf (score=90)

Fd2400i
...Swab top of container with 70% alcohol when appropri- b. Record time and date when samples.....Transfer rinse solution to sterile container by cutting "fill.. 5. Rinse Solutions, see CP.....Add required amount of rinse solution to each container.. b. If no colonies on RBC plate..
http://www.fda.gov/opacom/morechoices/fdaforms/FDA-2400i.pdf (score=90)

WAIS Document Retrieval
...FDA is proposing to limit the scope of the cut labeling provision to immediate container.....If cut labeling is used for immediate container labels, individual unit cartons, or.....container labels, individual unit cartons, or multiunit cartons containing immediate..
http://www.fda.gov/cder/dmpq/frpr7297.htm (score=90)

...IS THE CONTAINER AND PACKAGING CLOSURE STERILIZATION SYSTEM AND PRODUCT FILLING AND.....WHAT IS THE METHOD OF PREVENTING UNAUTHORIZED CHANGES IN CONTAINER/LID FLOW RATE DURING.....IF AN AUTOMATIC DEVICE IS USED TO MONITOR CONTAINER/CLOSURE FLOW RATES, HOW DOES THE FIRM..
http://www.fda.gov/opacom/morechoices/fdaforms/FDA3511-3.DOC (score=90)

potassium chloride in 5% dextrose and sodium chloride injection in plastic...
...Suspend container from eyelet support. institute appropriate therapeutic countermeasures.....Remove plastic protector from outlet port at bottom of container. fluid for examination if.....Remove container from IV pole and/or turn to an upright position. introduce additives, use..
http://www.fda.gov/medwatch/SAFETY/2003/03APR_PI/PotassiumChlorideinD5andNaCl_0.45.pdf (score=89)

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