March 14th 2025
The certification allows Benuvia to produce pharmaceutical products for companies, either local to Brazil or international, that may be looking for compliant and high-quality production capabilities in the Brazilian pharmaceutical market.
A guide to EFPIA's Mock P.2 document
EFPIA's 'Mock P.2' document aims to show how the role of 'quality risk management' and process analytical technology as an enabler for quality by design can be presented in a common technical document format. This article summarizes the main features of this document, and explains the key concepts and principles used.
Vial Defects Detected in Roche's Herceptin in Europe
November 30th 2006London (Nov. 22)-The European Medicines Agency reports a defect in some vials of Herceptin (trastuzumab), the anticancer treatment by Roche, which have been distributed in Europe. As a result, The EMEA's Committee for Medicinal Products for Human Use outlined a plan, formulated in conjunction with Roche, for the visually reinspecting and replacing defective vials.
Novartis Plans Additional Data on Manufacturing Issues for Mycograb
November 30th 2006Basel, Switzerland (Nov. 17)-Novartis plans to submit additional information to the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency on manufacturing issues to support the approval of its antifungal drug "Mycograb." The CHMP issued a negative recommendation for the drug.
BIO Calls for Updating WHO's Naming Policy for Biological Products
November 30th 2006Washington, DC (Nov. 13)-The Biotechnology Industry Organization is urging the World Health Organization to assign a distinct international nonproprietary name (INN) to each unique biological product, including follow-on biologics or biosimilars.
Perrigo Recalls 11 Million Bottles of Acetaminophen
November 16th 2006Over-the-counter drug maker Perrigo Company issued a voluntary recall of certain lots of store-brand acetaminophen 500-mg caplets that could contain trace amounts of metal particulate. Approximately 11 million bottles of acetaminophen are affected by the recall.
Novartis Conducts Fluvirin Recovery
November 3rd 2006Liverpool, UK (Oct. 20)-Novartis Vaccines and Diagnostics Limited is recovering two lots totaling 500,000 doses of its ?Fluvirin? influenza virus vaccine after reports that the product had been received from distributor Cardinal Health Care in either a frozen state or below the required storage temperature range of 35?46 degrees F.
Correlation of Visible-Residue Limits with Swab Results for Cleaning Validation
November 2nd 2006The correlation between swab assay results and visible-residue limits (VRLs) for cleaning validation was examined. Previously completed validation studies were reviewed to compare swab results with recently determined VRLs. A current cleaning validation study evaluated both swab testing and VRL. Unexpected swab results led to an investigation, which showed the value of establishing the VRL in conjunction with swab recoveries for cleaning validation programs.
FDA Offers Guidance for Reporting Deviations in Biologics Manufacturing
October 25th 2006The US Food and Drug Administration issued a guidance document to provide manufacturers of biological products (other than blood and blood components) with its current thinking on reporting requirements on deviations from current good manufacturing practices for biological products.
EFCG and SOCMA Urge More Inspection of Foreign API Makers
October 12th 2006CPhI Worldwide, Paris (Oct. 3)-The Synthetic Organic Chemical Manufacturers Association and the European Fine Chemicals Group have teamed to urge US and European regulatory authorities to increase inspections of foreign manufacturing facilities of active pharmaceutical ingredients (APIs) to reduce patient risk from sub-par drugs, to increase national security, and to level the economic playing field.
Court Refuses to Alter Compounding Decision
October 5th 2006Missouri City, TX (Oct. 3)-The US District Court for the Western District of Texas denied the Department of Justice?s motion to alter its Aug. 30 decision that the US Food and Drug Administration does not have the ability to regulate drug compounding.
FDA Releases Draft Guidance for Cell-Based Vaccine Development
October 5th 2006Rockville, MD (Sept. 28)-The US Food and Drug Administration has released the draft guidance for industry ?Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases.?
FDA Withdraws Three Outdated Electronic Submission Guidances
October 5th 2006Rockville, MD (Sept. 28)-The US Food and Drug Administration has withdrawn three guidances for industry: ?Providing Submissions in Electronic Format?NDAs? (e-NDA), ?Providing Regulatory Submissions in Electronic Format?ANDAs? (e-ANDA), and ?Providing Regulatory Submissions in Electronic Format: Annual Reports for NDAs and ANDAs.? These documents all recommend submitting information as portable document files (PDFs) or as SAS transport files.
China Emerges as the Next Frontier For Specialty Excipients
October 3rd 2006The specialty excipients market in the United States, Western Europe, and China is valued at nearly $800 million. The authors discuss the opportunities and challenges in these markets by examining the product mix, supply base, and preferred production methods.
Lean Manufacturing practice in a cGMP environment
October 1st 2006Developed in the 1950s as a means to survive and compete against the giants of the automotive sector, lean manufacturing helped Toyota evolve from a small-volume producer (with little capital) to become a high-volume manufacturer in a process-rich environment. Toyota achieved this by using developments such as total production maintenance (TPM), just-in-time (JIT), Kanban, value stream mapping and Kaizen events.1 A summary of some of the lean terminology is shown in Table 1.
SOCMA Petitions FDA to Increase Inspections of Offshore Drug Manufacturing Facilities
September 28th 2006The Bulk Pharmaceuticals Task Force (BPTF), an affiliate organization of the Synthetic Organic Chemical Manufacturers Association (SOCMA, Washington, DC) submitted a citizen petition to the US Food and Drug Administration (Washington, DC) requesting the agency to increase inspections of drug manufacturing facilities located outside of the United States.