From July 20 to 22, 2011, Conrad Chicago, USA Novatek International will be exhibiting its process-based Nova-EM Environmental Monitoring Management Software and other Nova-LIMS software solutions at the 2011 gbprinc.com, Practical Microbiological Approach to Non-Sterile Manufacturing & Quality Control in Chicago, Illinois, USA. Come visit us at Booth #1 for a live demonstration. Click the…Details
DIFFERENTIATION BETWEEN PHENOTYPIC AND GENOTYPIC IDENTIFICATION MECHANISMS
Recently, a Blog was published that identified the fifteen most common bacterial isolates identified by Accugenix, Inc, Newark, DE during 2010. This Blog created an interest in other related areas to include the best methods to assure a definitive identification of an isolated bacterium.
In a poster presented at the most recent American Society for Microbiology, Accugenix compared multiple technology solutions to determine the fitness for use studies beyond routine panels provided by manufacturers to understand both the performance and operation impact vs. the various environmental monitoring systems. The goal was to assure each customer the highest percentage of accurate identification to the species level. The systems compared permitted identification by either phenotypic or genotypic methods.Details
Risk Based Approach to Cleaning Validation & FDA Compliant Aseptic Processing & Environmental Monitoring Event – New Brunswick New Jersey USA
Novatek International was proud to have sponsored yet another successful Global Biopharmaceutical Resources, Inc. (GBPR, Inc.) event last week in New Brunswick NJ. Such a successful event was due in part to an impressive attendance of high expertise attendees and a variety of knowledgeable presenters. Interactive discussions were openly shared throughout the three day event addressing a variety of appropriate topics that are in line with today’s current industry trends in improving an organization’s overall quality standard and cGMP compliance.Details
FREQUENTLY ENCOUNTERED BACTERIAL ENVIRONMENTAL ISOLATES
Microbiological consulting professionals are often requested to assist Clients with the identification of various environmental microorganisms to include bacteria that are isolated from their various HVAC and Utility Systems during facility commissioning and on-going operations. These requests relate to controlling these isolates within Alert and Action Levels and never permitting them to migrate to Out of Trend (OOT) or Out of Specification (OOS) situations.
During environmental monitoring of ISO 5-8 controlled and classified areas, microorganisms are often isolated from airborne viable, settling, and contact plates and personnel. Knowing the identification and sources of these bacteria becomes essential to maintaining the control of the environment and minimizing contamination of the non-sterile or sterile process and the aseptic filling of the product. Personnel require this information to determine what sanitizer, disinfectant or sterilant to use.
Accugenix, Inc., Newark, DE has kindly provided the enclosed list of the fifteen most frequently obtained bacterial isolates during 2010. These bacteria represent primarily skin microflora and environmental isolates. One of the microorganisms isolated is also an anaerobe. Please note that no yeast, molds or streptomyces are included within this list which is presented in Table 1 below along with their frequency.
2011 PDA Annual Meeting San Antonio Texas USA Monday April 12, 2011 Novatek International speaks to David Matsuhiro, President, Cleanroom Compliance, Inc about a brand new class called Quality Systems for Aseptic Processing. TRANSCRIPT: “The PDA is developing a brand new class called Quality Systems for Aseptic Processing, which is going to supplement the aseptic…Details
2011 PDA Annual Meeting San Antonio Texas USA Monday April 11, 2011 Novatek International speaks to Frank S. Kohn, PhD. from FSK Associates Inc. about the latest regulatory requirements for Environmental Monitoring. TRANSCRIPT: “FSK Associates is an international consulting company in the area of contamination control and microbiology, our initials, our theme is really a…Details
Triad Group Hartland, WI Form FDA-483 Inspection Dates 11/29/2010 – 1/7/2011
Enclosed are comments from a total of seven observations representing various Systems to include Laboratory Control, Production, and Material obtained as a subset from the forty six observations within Triad Group’s recent FDA 483 which resulted in a recall of their alcohol prep pads, swabs, and swabsticks.
Laboratory Control System
Each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to such requirements.
Specifically, there is no finished product sterility testing or laboratory (b)(4) testing for sterile alcohol prep pads or sterile alcohol swabsticks.
§211.167(a) states “for each batch of drug product purporting to be sterile and or pyrogen-free, there shall be appropriate laboratory testing to determine conformance to such requirements.” SOPs should exist at each site to manage the sterility testing, USP<71> Sterility Tests, of product sold as “sterile”. In addition, SOPs should exist that cover such areas as Growth Promotion, (see USP<61> Enumeration of Microorganisms) , as well as the management of all of the equipment to include ISO 5 Sterility Test Hoods, refrigerators and incubators.Details
Johnson & Johnson McNeil-PPC Consent Decree and Permanent Injunction
The recent Consent Decree and Permanent Injunction against McNeil-PPC and two of its Vice Presidents recalled an article from March 2010 re: “FDA Recommends Increased Criminal Prosecutions of Responsible Corporate Officials…”. The initial paragraph is enclosed below. To obtain the entire article, please copy the Web site below. Please consider how the FDA’s activities may impact all Quality Management personnel.
FDA Recommends Increased Criminal Prosecutions of Responsible Corporate Officials; Important Questions Left UnansweredDetails
The FDA issued a Consent Decree of Permanent Injunction bypassing a Warning Letter in their persuit of J & J’s failure to comply with CGMPs.
For Immediate Release: March 10 2011
Media Inquiries: Shelly Burgess, 301-796-4651; firstname.lastname@example.org
Consumer Inquiries: 888-INFO-FDA
FDA, Justice Department take action against McNeil-PPC Inc.
Charged with manufacturing and distributing OTC drugs in violation of federal law
The U.S. Food and Drug Administration announced today that a consent decree of permanent injunction has been filed against McNeil-PPC and two of its officers for failing to comply with current good manufacturing practice requirements as required by federal law. The action prevents McNeil, a subsidiary of Johnson & Johnson, from manufacturing and distributing drugs from its Fort Washington, Pa., facility until the FDA determines that its operations are compliant with the law.Details
FDA 483 TRIAD GROUP OBSERVATIONS (H & P Industries) 11/29/10 -01/07/11
Enclosed are three of the forty six Observations along with commentary from the 30 page Triad Group FDA 483. These three Observations focus upon the training and education within the Triad Group as noted by the FDA during their investigation. It should be observed within these Observations that the FDA has noted that individuals performing various tasks should possess the various skill sets necessary to perform their functions. The FDA questions the ability of a chemist who has limited microbiological skills to provide training to personnel.Details