ABC Compounding Company, Inc. Warning Letter
...The three year stability test results for HAND AID Instant Hand Sanitizer indicate that it fails to.....You have failed to establish an adequate stability testing program to determine appropriate expiration dates for all your drug.....While this singular lot provides positive information regarding the product s stability, earlier stability..
http://www.fda.gov/foi/warning_letters/g5091d.htm (score=100)

HUMAN DRUG CGMP NOTES December, 1996
...However, because the technology may not have been available, older applications lacking.....Concern about the potential health effects to people working with DOP test aerosols has.....An FDA-483 observation would be appropriate if failure to meet the tighter internal..
http://www.fda.gov/cder/hdn/cnotesd6.htm (score=43)

Untitled Document
...Regarding your investigation of the Mumps Vaccine stability test failures, it did not include.....Failure to follow an appropriate written testing program designed to assess the stability.....Failure to describe in an annual report any changes in the production process or test i..
http://www.fda.gov/foi/warning_letters/g4238d.htm (score=40)

MDI and DPI Drug Products
...manufacturing, processing, packaging, controls, stability testing, or labeling operations.....discuss significant departures from the approaches outlined in this guidance with the.....quantitative test with appropriate acceptance criteria should be established for the.. 474..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=38)

Guidanc for Industry: Container and Closure Integrity Testing in Lieu of...
...test with an appropriate container and closure integrity test in the stability protocol.....than sterility testing to confirm container and closure integrity as a part of stability.....methods for the sterility test for sterile biological products, human and veterinary drugs..
http://www.fda.gov/cber/gdlns/contain.pdf (score=35)

HUMAN DRUG CGMP NOTES March 1999
...For example, if the protocol deviation was well documented by the firm in both its stability test.....113 require firms to establish and follow appropriate written procedures designed to.....Should investigators cite firms for not conducting accelerated stability testing during..
http://www.fda.gov/cder/hdn/cnotes39.htm (score=34)

GUIDE 1 Note: This document is reference materials for investigators...
...They may accept stability test results showing an apparent increase in the assay of the drug with.....Evaluate the company's retesting SOP for compliance with scientifically sound and.....If there is no stability-indicating assay additional assay procedures such as TLC should..
http://www.fda.gov/ora/inspect_ref/igs/pharm.html (score=33)

HUMAN DRUG CGMP NOTES December 1998
...As of May, 1998, TOC is the official organic impurities test for USP pharmaceutical.....The CGMPs require that the reliability of the supplier's results be conducted at.....test is conducted on such component by the manufacturer, and provided that the..
http://www.fda.gov/cder/hdn/cnotesd8.htm (score=32)

Guidance In the Manufacture and Clinical Evaluation of In Vitro Tests to...
...licensed HIV-1 antibody test kit and in June 1996, a supplemental Western Blot test to.....potency and stability of the reagents on storage and under cycling conditions should be.....appropriate test samples are obtained for all donations included in a pool and..that all..
http://www.fda.gov/cber/gdlns/hivnas.pdf (score=31)

stability guidance -draft
...products, testing at the beginning and the end of the stability test period may be.....appropriate stability studies on batches of product, and submit the information in an.....should be assayed for the chemical content of the preservatives at all appropriate test..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=101)

Guidance for Industry: Manufacturing, Processing, or Holding Active...
...These tests should include, as appropriate, purity, impurity profiles, stability testing.....Deviations from written specifications, standards,sampling plans, test procedures, or.....A formal testing program should be established to assess the stability characteristics of..
http://www.fda.gov/cder/guidance/1289dft.pdf (score=100)

Guidance for Industry
...provided that they meet appropriate standards or specifications as demonstrated by.....We recommend that an individual responsible for performing an odor test not have an.....There must be a written testing program designed to assess the stability characteristics..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0165-gdl0001.pdf (score=100)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...stability parameters include radiochemical identity and purity, appearance, pH, stabilizer.....of false-positive results arises in the sampling and transfer of the test aliquot from the.....errors and ensure that appropriate corrective action is taken to prevent their recurrence..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=99)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...Appropriate stability-indicating methods that can distinguish degradation products and impurities.....The reliability of the supplier's test results can be established by conducting.....Appropriate parameters should be evaluated to establish and document the stability of a..
http://www.fda.gov/cder/guidance/4259dft.htm (score=99)

Validation of Chromatographic Methods
...Data that are generated for acceptance,release, stability, or pharmacokinetics will only.....needed for sample preparation or solution storage, an appropriate..stability time should.....The objective of a test method is to generate reliable and accurate data regardless of..
http://www.fda.gov/cder/guidance/cmc3.pdf (score=99)

Packaging
...In these early stages, the IND should also indicate that appropriate stability studies with the.....A further test to supplement the mouse subchronic systemic test is the procedure for eye.....Samples of a drug that are selected for stability studies should be packaged in the..
http://www.fda.gov/cder/guidance/package.htm (score=98)

Human Drug Notes
...In the latter case, until appropriate stability data is generated, the expiration date assigned to.....In such an instance, there is no proof that the identity test is being done and a periodic.....Calibration of the analyzer zero step at weekly intervals may be appropriate if a..
http://www.fda.gov/cder/hdn/hdn1295.htm (score=97)

GUIDE TO INSPECTIONS OF DOSAGE FORM DRUG MANUFACTURER'S - CGMPR'S
...Determine if expiration dates, based on appropriate stability studies, are placed on.....When spore test strips are used to test the effectiveness of ethylene oxide sterilization, be aware that.....Test is used, review the FDA "Guideline on Validation of the Limulus Amebocyte Lysate Test..
http://www.fda.gov/ora/inspect_ref/igs/dose.html (score=96)

þÿ
...process test and the drug substance test, the acceptance criterion for the in-process test.....should explain the scientific reasons why a stability indicating procedure is not viable.....apply the content recommendations in this guidance, as scientifically appropriate, and/or..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=36)

þÿ
...process test and the drug substance test, the acceptance criterion for the in-process test.....should explain the scientific reasons why a stability indicating procedure is not viable.....apply the content recommendations in this guidance, as scientifically appropriate, and/or..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=35)

Las Vegas Injury Lawyer