CDER NAMES THESE TEN (21 CFR 211) The following represent those most frequent Observations that CDER posted for fiscal year 2010 based on a total of 646 FDA Form 483. REFERENCE FREQUENCY SHORT DESCRIPTION 211.22(d) 149 Procedures not in writing, fully followed 211.100(b) 104 SOPs not followed/documented 211.192 98 Investigations of discrepancies, failures 211.160(b) 83…Details
Challenges and Successes in Implementing an Electronic Environmental Monitoring Data Management Solution
From September 12 to 13, 2011, Basel, Switzerland It is with great pleasure that Susan Cleary, B.C.S, M.B.A., Associate Director of Product Development at Novatek International will be speaking at this year’s Europe GBPR, Inc. event on Challenges & Successes in Implementing an Electronic Environmental Monitoring Data Management Solution September 12 to 13, 2011 in…Details
ACCUGENIX IDENTIFIED WHAT MICROORGANISMS REPRESENT THE OTHER 50%
While having knowledge of the most frequently identified bacteria is informative, it is important to note that these Top 15 bacteria identified from manufacturing environments, as cited in the original post, only represent approximately 50% of the microbes that are identified during routine monitoring and investigations . These microorganisms represent the diversity of bacteria from across the Pharmaceutical, Medical Device, Personal Care and Cosmetics, Neutraceutical and Biotechnology production facilities; the analysis did not include the fungi and yeast that are also isolated from these environments. As determined by Accugenix, the remaining 50% of the bacteria comprise 1,964 unique species which were identified in Environmental Monitoring programs — a number that implies that following the environmental ecology by methods such as colony morphology and Gram staining, as suggested, would be daunting. Pharmaceutical environmental monitoring programs have resulted in the identification of 1,979 unique bacterial species by Accugenix over the last five years. Indicating how critical it is that the identification libraries or databases, against which you compare your data whether generated by phenotypic, prototypic or genotypic methods, contain all relevant species or the interpretation of your data is not reliable. It is also critical to realize that this list of the Top 15 frequently encountered bacteria is a reflection across all industries and manufacturing sites. Specific manufacturing facilities may have different distribution of frequently occurring microorganisms, depending on their environment.
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