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.
The RAPS store will be under maintenance Saturday, 17 April between 5 AM and 12 PM EST. Store functionality may be unavailable at times during this window. We apologize for any inconvenience caused during this time.
Posted 26 May 2016 | By Zachary Brennan
India’s Central Drugs Standards Control Organization (CDSCO) on Thursday released a new draft checklist and evaluation tool for pharmaceutical inspectors of manufacturing sites in India.
The checklist and tool will help CDSCO and state inspectors understand and collaborate on which pharmaceutical and active pharmaceutical ingredient (API) manufacturing sites have been inspected and are compliant.
“The inspections are planned to be carried out jointly by the CDSCO officials and Drug Inspectors of the States concerned. The inspections will assess the compliance of manufacturing facilities with the specified GMP and GLP requirements and also seek to harmonize the procedures for conduct of inspections throughout the country, identify gaps in such compliance and communicate the same to the manufacturers for compliance,” CDSCO said in public notice.
CDSCO also said it will take suggestions and amend the checklist and tool after stakeholders weigh in.
As part of efforts to improve manufacturing quality on the subcontinent, the Indian regulator also initiated a week-long training program on the checklist and evaluation tool, as well as other related areas to ensure the inspections don’t cause “any undue harassment to the manufacturers or their employees and the inspections are carried out in an objective and transparent manner.”
The first of these training programs was conducted between 9 May and 14 May, and the second training program is currently in progress at the National Institute of Biologicals.
Among the items on the checklist are questions on the location and surroundings, building and premises, water and waste system and other pertinent details on warehousing, production, quality control and manufacturing operations and controls.
The notice comes as the US Food and Drug Administration has increasingly been citing Indian manufacturers for data integrity issues dating back to at least 2013, and most recently in April. In some of the most egregious cases, companies have overwritten data collected by software or deleted pertinent data.
Public Notice
GMP Checklist
Tags: Indian drug manufacturing, API manufacturing, data integrity
Regulatory Focus newsletters
All the biggest regulatory news and happenings.