Novatek International speaks to Mike Parkes, COO of RCA Regulatory Compliance Associates at the 2012 PDA Annual in Phoenix Arizona. TRANSCRIPT: Cheryl: “We are at PDA annual at Phoneix Arizona. It is an honor and a pleasure to be standing here with Mike Parkes. He is the COO of RCA.” What I wanted to ask…Details
The Environmental Monitoring Data Management & Trending System Software – The Industry Standard It seems like just yesterday, when the Pharmaceutical Microbiology Forum Newsletter – March 2004, Vol. 11 (1) was published. One of the hot topics at the time was Environmental Monitoring (EM) and the question of the day was: How many people are…Details
April 16-18, 2012 – Phoenix, AZ Novatek International will be exhibiting its process-based LIMS software solutions at the 2012 PDA Annual Meeting: Manufacturing Innovation: Achieving Excellence in Sterileand Emerging Biopharmaceutical Technology, April 16-18, 2012 in Phoenix, AZ USA Come visit us at Booth #512 for a live demonstration. For more detail follow this link: 2012…Details
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.
March 12-15, 2012 – Orlando, FL
Novatek International will be exhibiting its process-based LIMS software solutions at the Pittcon Conference & Expo from March 11-15, 2012 in Orlando, FL USA. Come visit us at Booth #1884 for a live demonstration.
For more details follow this link:
Pittcon Conference & Expo
Biomedical Engineering: Healthcare Systems, Technology & Techniques Chapter 1 Submission by Novatek International
Novatek International is very proud to announce that Mr. Aram Montazami, Vice president of R&D at Novatek International has contributed to the recent Springer publication: Biomedical Engineering: Health Care Systems, Technology and Technique. The Biomedical Engineering series is an edited volume with contributions from world experts. It provides readers with unique contributions related to current…Details
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.
Join Novatek International at Booth # 12 at PDA’s 6th Annual Global Conference on Pharmaceutical Microbiology October 17-18: “Challenges Facing Pharmaceutical Microbiology in the 21st Century” at Bethesda North Marriott Hotel and Conference Center, Bethesda, Maryland USA.
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…Details
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 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.Details