Novatek International is very proud to announce that Mr. Parsa Famili, CEO and President of Novatek International was the keynote speaker of the Pharmaceuticals Executive Meeting and Discussions in Jakarta, Indonesia. During this meeting scientific processes of Indonesian Pharmaceutical companies and Novatek solutions were discussed. Novatek routinely participate in high level scientific and corporate discussions…
Novatek International is very proud to announce that Mr. Richard Sasseville, Associate Director of Product Innovations was part of a delegation that met with Dr. Jeremy M. Levin, DPhil, MB, BChir, President and CEO of TEVA Pharmaceuticals in Israel recently. During this meeting scientific processes of TEVA and Novatek solutions were discussed. Novatek routinely participate…
Featuring a Summary of Ben Venue Issues Policy changes and enforcement strategies implemented by the FDA have led to an increase in the number of inspection of both Contract Manufacturing Operations (CMOs) and in-house sterile manufacturers — especially injectables. There has been a greater oversight and detailed review of all protocols and processes. Any issue…
CDER RELEASES A NEW PET DRAFT GUIDANCE CDER has released as a DRAFT the following Guidance for Industry, “Media Fills for Validation of Aseptic Preparation for Positron Emission Tomography (PET) Drugs. The Comment period will be 90 days. Please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM273766.pdf to obtain this DRAFT document.
IPA – Effective Cleaning Validation Practices & Critical Cleaning Processes for Pharmaceuticals & Biotech Industries Novatek International will be exhibiting its process-based regulatory compliant software solutions at the International Pharmaceutical Academy (IPA) event on Effective Cleaning Validation Practices. The event is to be held October 12-13, 2011 – Montreal, QC. Click the link below for…
PART 610.12 — CBER GENERAL BIOLOGICAL PRODUCTS STANDARDS PROPOSED Enclosed is the summary of the proposed requirements for the revised CBER 610.12 Sterility Test. For additional information, please see below for a summary or visit the enclosed web site for the full release http://www.gpo.gov/fdsys/pkg/FR-2011-06-21/pdf/2011-15346.pdf The authority citation for 21 CFR part 610 continues to read…
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…
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 .…
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…