Karen A. Clark, Product Manager, Anatel Corporation
ISPE, October 2000 In the pharmaceutical industry, Good Manufacturing Practices (GMPs) require that the cleaning of drug manufacturing equipment be validated.1 Many different validation techniques can demonstrate that the manufacturing equipment is cleaned and essentially free from residual active drug substances and all cleaning agents.Common analytical techniques in the validation process include HPLC, spectrophotometry (UV/Vis), and TOC. HPLC and UV/Vis are classified as specific methods that identify and measure appropriate active and substances. TOC is classified as a non-specific method and is ideal for detecting all carbon-containing compounds including active species, excipients, and cleaning agent(s). 2,3,4,5.
For full article Click Here
Sunday, February 24, 2008
Defining Three “Consecutive” Runs
Destin A. LeBlanc,Cleaning Validation Technologies,Technical Consulting ServicesCleaning Memo for MARCH 2004 Another question I commonly get is “What constitutes three consecutive runs for cleaning validation protocol purposes?” The basic approach to answering this question is to use the same principles one uses for process validation. If I am validating a blending process in a certain manufacturing vessel, do the three validation runs have to be one after the other, with no intervening product being processed? Or, in between the three manufacturing processes for the validation, am I allowed to blend other products? Most people would agree that the latter is appropriate for process validation.
For full text article Click Here
For full text article Click Here
Cleaning Verification Case Studies
David DeLucia,
ISPE , January 1997 Creative BioMolecules operates a cGMP plant with 1000L mammalian cell and 1000 L bacterial fermentation capacity. The plant is used for contract manufacturing as well as for CBM’s proprietary products. These case studies will review five campaigns of five products over the last three years. In each case, the goal was to demonstrate that the equipment was properly cleaned and ready for the next campaign.
For more information Click Here
ISPE , January 1997 Creative BioMolecules operates a cGMP plant with 1000L mammalian cell and 1000 L bacterial fermentation capacity. The plant is used for contract manufacturing as well as for CBM’s proprietary products. These case studies will review five campaigns of five products over the last three years. In each case, the goal was to demonstrate that the equipment was properly cleaned and ready for the next campaign.
For more information Click Here
Cleaning validation in active pharmaceutical plants – guidance, 2000
APIC Guide to Cleaning Validation in API plants This Guideline has been produced by the Active Pharmaceutical Ingredients Committee(APIC) Working group.Different organizations will be influenced by their companies and the markets that theyserve in the approaches that they take and the policies that they have with respect tothe subject.It is also valuable to bear in mind that this is an area that is changing rapidly and whatwas considered as being acceptable 2-5 years ago is now not adequate. Therefore,companies should be aware of the need to continuously update themselves on currentregulatory requirements.
For full-text article Click Here
For full-text article Click Here
College of American Pathologists (CAP) Residue Detection Method
Detergent Residue Testing using a pH Meter, pH Indicator, or Test Kit The following test procedures are suitable for detecting detergent residues resulting from improper rinsing and can be used to meet laboratory accreditation guidelines and questionnaires such as the College of American Pathologist program of State water lab accreditation programs.
For more information Click Here
For more information Click Here
Subscribe to:
Posts (Atom)