610.12 CBER PROPOSED STERILITY TESTS

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.

MEDIA FILLS FOR VALIDATION OF ASEPTIC PREPARATIONS FOR POSITRON EMISSION TOMOGRAPHY (PET) DRUGS

CDER RELEASES A NEW PET DRAFT GUIDANCE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.

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…

Xplore and Novatek Partner to Provide Rugged Tablet Solution Specialized for the Pharmaceutical & Biopharmaceutical Industry

Novatek International’s commitment to providing regulatory compliant software solutions to the pharmaceutical and biotech industries takes another leap forward with their newest addition to their Nova-EM Environmental Monitoring Management process, Nova-EM Mobile. In collaboration with Xplore Technologies’  iX104c5 DMCR (Dual-Mode Clean Room Tablet ) , the Nova-EM Mobile solution offers an effective real-time data collection…

Risk Based Environmental Monitoring & Efficiencies Gained With Use of an Automated System – An Industry Roundtable Discussion

The Southern California Discussion Group of the ASQ Biomedical Division Presents: Risk Based Environmental Monitoring (EM): How to use risk to ensure your EM Program is value added & efficient An Industry Roundtable Discussion Non-viable air, viable air, and surface monitoring of controlled environments is not a new concept and has been a regulatory requirement…

Novatek CEO, Parsa Famili attends a reception in honor of Australian Prime Minister, The Honorable Tony Abbott hosted by The Honorable Stephen Harper, Prime Minister of Canada

Earlier this week, Canada was pleased to welcome The Honorable Tony Abbott, Prime Minister of Australia. A dinner reception at The Fairmont Château Laurier, Ottawa was held in honor of The Honorable Tony Abbott MP Prime Minister hosted by The Honorable Stephen Harper Prime Minister of Canada. Here was the platform of where our two…

TOP 15 BACTERIA REPRESENT 50% OF BACTERIAL ISOLATES IDENTIFIED

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 . These microorganisms represent the diversity of bacteria from across the Pharmaceutical, Medical Device, Personal Care and Cosmetics, Neutraceutical and Biotechnology production facilities; the analysis did not include the fungi and yeast that are also isolated from these environments.  As determined by Accugenix, the remaining 50% of the bacteria comprise 1,964 unique species which were identified in Environmental Monitoring programs — a number that implies that following the environmental ecology by methods such as colony morphology and Gram staining, as suggested, would be daunting. Pharmaceutical environmental monitoring programs have resulted in the identification of 1,979 unique bacterial species by Accugenix over the last five years. Indicating how critical it is that the identification libraries or databases, against which you compare your data whether generated by phenotypic, prototypic or genotypic methods, contain all relevant species or the interpretation of your data is not reliable.  It is also critical to realize that this list of the Top 15 frequently encountered bacteria is a reflection across all industries and manufacturing sites.  Specific manufacturing facilities may have different distribution of frequently occurring microorganisms, depending on their environment.

2nd PDA Europe Annual Meeting

Join us for the second year at the 2nd PDA Europe Annual Meeting in Berlin, Germany this June! After the tremendous success of the first PDA Europe Annual Meeting, we look forward to the second edition of this conference in Berlin, Germany, 13 – 14 June. The main theme of this 2nd PDA Europe Annual…

Details