PDA 2011 – Latest Regulatory Requirements for Environmental Monitoring

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…



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 as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 264.

Section 610.12 is revised to read as follows:

§ 610.12 Sterility.

(a) The test.

Except as provided in paragraph (h) of this section, manufacturers of biological products must perform sterility testing of each lot of each biological product’s final container material or other material, as appropriate and as approved in the biologics license application or supplement for that product.

(b) Test requirements.

(1) The sterility test must be appropriate to the material being tested such that the material does not interfere with or otherwise hinder the test.

(2) The sterility test must be validated to demonstrate that the test is capable of reliably and consistently detecting the presence of viable contaminating microorganisms.

(3) The sterility test and test components must be verified to demonstrate that the test method can consistently detect the presence of viable contaminating microorganisms.



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.

Effective Cleaning Validation Practices & Critical Cleaning Processes For Pharmaceuticals & Biotech Industries Addressing the most Current Requirements & Practices for Cleaning Validation

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…

Current Contract Manufacturing Operation (CMO) Regulatory Issues

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 or potential issue must have a corrective action with a demonstrated positive outcome. There no longer exists a prescribed sequence of events after a Form FDA 483 is issued. Contract Manufacturing Operations, in particular, must now have strategies to ensure GMP compliance at their facilities involved in “arms length” activities with innovator and generic firms and be prepared for more frequent and thorough audits. 

Novatek International Travels to Israel

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…

Novatek International Travels to Indonesia November 2012

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 Travels to the Philippines

Novatek International organized an open forum with various Philippine Pharmaceutical Associations. Novatek’s objectives during this event were: To provide an update on global trends and guidelines (and present the Novatek solutions suite and examples of its capacity building activities with the pharmaceutical industry in other regions). To identify priority capacity building needs of the Philippine…