Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
RAPS Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 27 March 2013 | By Alexander Gaffney, RAC,
Most of the time, manufacturers are concerned with keeping potential contaminants, including things that might casually be found in a forest, out of the drug production process. But a new Warning Letter sent to pharmaceutical manufacturer Keystone Laboratories by the US Food and Drug Administration (FDA) shows that the company allegedly thought differently, going as far as to use wooden sticks in its manufacturing process, earning the ire of FDA inspectors.
The 18 March 2013 letter references an August 2012 inspection by FDA at the company's Memphis, Tennessee manufacturing facility. While there, FDA wrote that its investigators uncovered a host of violations unusual in both their severity and rarity.
[Editor's Note: A previous iteration of this article said the company's plant was located in Bozeman, Montana. The company's headquarters is there. We regret the error.]
For example, the company used wooden sticks and cardboard covers on production equipment. It is unclear how the sticks were used, but FDA noted they came into direct contact with drug products, while the cardboard was used to cover the products during processing. Neither are appropriate for pharmaceutical production due to their physical properties, which make them difficult to sanitize.
But just as troubling to investigators were other repeat observations, such as condensation seen leaking into a bucket. Elsewhere, vessels used to measure and mix drug products were observed to have deep, "rust-like stains," while other equipment was observed to have "visible build-up and filth."
These same observations had been made in 2009 and 2011, FDA claimed.
Neither did the company conduct adequate testing on released products as required by regulations.
"For example, the water you use in your drug products is a component with the potential for microbiological contamination which is objectionable in view of the component's intended use," FDA explained to the company in its Warning Letter. "Notwithstanding this, your firm failed to subject the water to routine microbiological testing. Furthermore, your firm failed to validate the water system to ensure consistent water quality for drug production and implement procedures for maintaining or monitoring the quality of the water produced.
Keystone also exhibited a number of non-manufacturing violations, FDA alleged. Several products, including the company's Long Aid Medicated Hair Revitalizer Anti-Itch Formula, ULTRA GLOW Fade Creams, and BETTER BRAIDS Hair Care Products were all observed to be misbranded under federal law due to their lack of conformity with monographs for labeling.
Further, FDA claimed that the company failed to register with the agency as required by law, rendering all products manufactured by it misbranded by default. This, too, is a repeat observation from 2011.
In light of multiple and repeat offenses, FDA said it had significant concerns about the company's quality operations.
"Repeat citations from prior inspections indicate your quality control unit is not exercising its responsibilities, and may not have the appropriate authority to carry out its responsibilities," FDA wrote. "Due to continuing CGMP issues at your firm, we recommend you engage a third party consultant with appropriate CGMP expertise to assess your firm's facility, procedures, processes, and systems to ensure the drugs you manufacture have their appropriate identity, strength, quality, and purity."
The company has 15 working days to respond to the letter.
Tags: warning letter
Regulatory Focus newsletters
All the biggest regulatory news and happenings.