Sterile liquids are frequently transferred during the processing of sterile liquid drugs such as injectables or ophthalmic drops. Several types of transfer can be performed, each requiring a validated method to ensure the desired sterility-assurance levels are achieved.
It has been a long time coming, but stakeholders in the US are now seriously debating a route to market for cheaper copies of biopharmaceutical drugs. The European Agency for the Evaluation of Medicinal Products (EMEA) has led the way on this issue by publishing clear guidelines on what companies must do to get their versions of drugs such as erythropoietin (EPO), an advanced treatment for anæmia, and similar products approved.
Rockville, MD (May 25)-The US Food and Drug Administration issued a Form FDA 483, Inspectional Observations, to the Liverpool, United Kingdom, facility of MedImmune, Inc., citing deviations from current good manufacturing practices.
AAI, AstraZeneca, Biovail, West, more
Washington, DC (May 3)-The Biotechnology Industry Organization published a position paper stating that any legislation establishing a regulatory pathway for follow-on biologics should grant pioneering products 14 years of data exclusivity.
London (May 1)-The European Medicines Agency launched a database designed to facilitate the exchange of information about compliance with good manufacturing practices.
Washington, DC (April 30)-Less than two weeks after the Senate Health, Education, Labor, and Pensions Committee voted to reauthorize the Prescription Drug User Fee Act (PDUFA), the bill this week moved onto the Senate floor.
Rockville, MD (May 1)-The US Food and Drug Administration issued a guidance to alert pharmaceutical manufacturers, pharmacy compounders, repackers, and suppliers to the potential public health hazard of glycerin contaminated with diethylene glycol (DEG), a poison.
Breaking up is easy to do.
Fewer field offices and inspectors will increase reliance on manufacturers to ensure product and process quality.
Sanofi to Close Irish Plant, FDA Inspections and Warning Letters Continue to Decline, FDA Submits Final Proposals for PDUFA IV, and more.
USP applies metrological principles to the dissolution procedure alone and in collaborative studies to understand and minimize potential sources of variability.
San Juan, PR (Apr. 25)-Regulatory and quality issues were prominent discussion topics at this year?s ExcipientFest conference and exhibition.
Interphex2007, New York, NY (Apr. 26)-Robustness studies for analytical methods are critical in being able to provide the assurance to the quality of an analytical method, a topic addressed in a conference session, "Performing Analytical Method Validation Robustness for Regulatory Compliance," at Interphex on Thursday.
Interphex2007 (Apr. 25)-As the pharmaceutical industry moves to a risk-based approach in manufacturing, analytics will play a critical role in not only meeting regulatory requirements but also in building needed collaboration between product development and manufacturing groups.
Interphex, New York, NY (Apr. 24)-Although the second revision of 21 CFR Part 11, the Electronic Records and Signatures Rule, has not been finalized, there is some progress being made. This was the topic of a presentation given by John English, manager of computer system validation for BE&K BioPharm at today?s Interphex Pharmaceutical Manufacturing Conference and Exhibition.
Lyon, France (Apr. 17)-Sanofi Pasteur, the vaccine division of the Sanofi-Aventis Group, announced that the US Food and Drug Administration has licensed its H5N1 vaccine, making it the first avian-influenza vaccine for humans in the United States.
Rockville, MD (Apr. 5)-The US Food and Drug Administration concluded its reinspection of Wyeth?s manufacturing facility in Guayama, Puerto Rico. Conditions at the Guayama facility prompted a Warning Letter in May 2006.
Brussels, Belgium (Mar. 22)-The European Commission?s (EC) Directorate-General for Enterprise and Industry (Brussels, Belgium) is asking manufacturers, distributors, and users of human-pharmaceutical excipients to participate in an online questionnaire on the effect of various policy options. Responses will be used to prepare a directive on good manufacturing practices (GMPs) for certain excipients.
Rockville, MD (Mar. 1)-The number of US Food and Drug Administration inspections of biologic and drug-manufacturing facilities declined to 4237 in fiscal 2006, according to a report by the Office of Regulatory Affairs.
Forty years ago, investors and business speculators shuddered at the prospect of working with India's pharmaceutical industry. The industry was plagued by archaic patent laws and insufficient infrastructure, and only multinational companies (MNCs) were able to exploit its crude resources and monopolistic legal framework. Struggling in the shadows of these MNCs were the Indian pharmaceutical entrepreneurs and a handful of producers. Because more than 70% of the pharmaceutical market value was in the hands of MNCs, India's indigenous pharmaceutical industry was floundering. Its amount of exports was negligible, and the domestic market outlook was bleak because of onerous government regulation.
BIO Raises Concerns About Studies on Follow-On Biologics; Green Chemistry Reduces Costs and Waste; Novel Polymer–DNA Delivery System; WHO Stresses Lack of Capacity for Pandemic Flu Vaccine; EGA Concerned About Regulatory Workload in Approving Generics
The enactment of the Indian Patents Act of 1970, implemented in 1972, provided an open platform to the Indian pharmaceutical industry to adopt process patents to manufacture active pharmaceutical ingredients (APIs) and formulations without fear of infringement of product patents. This resulted in a phenomenal growth in the number of pharmaceutical manufacturing units, from 2257 in 1970, to 5156 in 1980, 16,000 in 1990, and more than 23,000 in 2005. This was accompanied by a steep increase in investment from Rs. 2.25 billion (approx. $250 million US) in 1973, to Rs. 45 billion (approx. $1 billion US) in 2002–03. The prices of the most advanced drugs dropped significantly in India, leading the Indian pharma sector to become more competitive while remaining extremely cost effective in the global market.
The concept of Acceptable Analytical Practices (AAPs) was developed by the Analytical Technical Group of the Pharmaceutical Research and Manufacturers of America to share information about how the pharmaceutical industry has implemented chemistry, manufacturing, and controls and quality guidances of the International Conference on Harmonization and worldwide regulatory authorities. The AAP process identifies and addresses critical issues in which guidance is lacking, ambiguous, or contradictory. AAPs were designed to provide a forum where one could learn from the experience of experts in pharmaceutical analysis and enhance the understanding of analytical practices that reflect good science and sound regulatory compliance. This article summarizes the discussion points from a meeting regarding the Justification of Specifications topic.
Mishaps in packaging labels serve as a reminder: the recall is in the details.
