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 Unanswered
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.
Frank S. Kohn, PhD, SM(NRM),ASCP,CCM
FSK Associates, Inc.
Manson, Iowa 50563 USA
This two part technical report will put forward series of recommendation for a quality management program for Environmental Monitoring and Control. This included an evaluation of industry practices, regulatory requirements, and current methods utilized by Biopharmaceutical plant sites. The result of this effort has developed into a listing of several recommendations for potential implementation at plant sites. These recommendations include environmental monitoring controls at all stages of product development and supply chain production.
The management and control of an acceptable environmental program is extensive and comprehensive. This is the reason for a brief over view of the subject to assist in understanding the recommendations provided.Details
TRIAD GROUP – VOLUNTARY PRODUCT RECALL
JANUARY 5, 2011
FOR IMMEDIATE RELEASE – January 5, 2011 – Hartland, Wisconsin, Triad Group, a manufacturer of over-the-counter products has initiated a voluntary product recall involving ALL LOTS of ALCOHOL PREP PADS, ALCOHOL SWABS, and ALCOHOL SWABSTICKS manufactured by Triad Group but which are private labeled for many accounts to the consumer level. This recall involves those products marked as STERILE as well as non-sterile products. This recall has been initiated due to concerns from a customer about potential contamination of the products with an objectionable organism, namely Bacillus cereus. We are, out of an abundance of caution, recalling these lots to ensure that we are not the source of these contamination issues.
Use of contaminated Alcohol Prep Pads, Alcohol Swabs or Alcohol Swabsticks could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients. To date we have received one report of a non-life-threatening skin infection.
Prep Pads, Swabs and Swabsticks containing alcohol, typically sold as 70%, act as surface sanitizers/disinfectants. Alcohol can readily kill vegetative non-spore forming cells, but spore forming microorganisms (spore forming bacteria and mold) are highly resistant. Alcohol may be filter sterilized to remove bacteria, yeast and mold prior to saturation of the various transfer devices; however, to assure a low bioburden content of the Prep Pads, Swabs and Swabsticks, these carriers should be irradiated to assure the removal of various spore forming microorganisms. Without the performance of both preventative measures, there is a high probability of spore forming microorganisms being present within either the alcohol, the alcohol carrier or both.
WARNING LETTER FEBRUARY 9, 2011
SANOFI AVENTIS DEUTSCHLAND GmbH (Part 2)
2. Your firm has not established separate or defined areas or such other control systems as necessary to prevent contamination or mix-ups during aseptic processing. [21 C.F.R. § 211.42(c)]. For example,
a) The airflow velocity inside critical areas of the aseptic processing operations of Line (b)(4) was found unacceptable by FDA. The documentary evidence of in-situ air pattern analysis (e.g., smoke studies) reviewed during the inspection confirmed this condition.Details
WARNING LETTER FEBRUARY 9, 2011
SANOFI AVENTIS DEUTSCHLAND GmbH
1. Your firm has not established or followed appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile [21 C.F.R. § 211.113(b)].
21 C.F.R. § 211.113(b) states that “appropriate written procedures, designed to prevent microbiological contamination of drug products purporting to be sterile, shall be established and followed”. This includes all aseptic and sterilization processes.
“Chemical Indicators (Verify SixCess Class 6 Challenge Packs and Chemical Indicators) Should Not Replace Biological Indicators (BIs)”
Steris Corporation has developed chemical indicators that have been approved by the FDA to “monitor physical conditions”. While the FDA has approved this use, they recently issued this Warning Letter because the Steris literature appears to imply that their indicators remove the need for Biological Indicators. Biological indicators, as noted above by the FDA, measure the sterility assurance of the removal of microorganisms.
“The… FDA has reviewed several brochures and other promotional materials as well as the website for STERIS Corporation’s Verify SixCess Class 6 Challenge Packs and Chemical Indicators. Chemical indicators are devices within the meaning of section 201(h) of the Federal Food, Drug and Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) Cosmetic Act. The labeling originally submitted by Steris to the Office of Device Evaluation (ODE) in the 510(k)s for the Verify Chemical Indicators and Challenge Packs included the following claim:
“The performance of the Verify (specific name) indicator exceeds that of biological indicator kill and meets the requirements of ANSI/AAMI/ISO 11140 for Class 6 steam indicators.”Details