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.
Preparing Documentation to Support Clinical Supply Manufacture
August 1st 2007This article is written to assist clinical manufacturing representatives at pharmaceutical companies who are faced for the first time with outsourcing the manufacture of clinical supplies. The author describes the identification, writing, and execution of documents required to support the contract manufacture of products for clinical studies.
New FDA Guidance on Polymorphic Compounds in Generic Drugs
July 12th 2007A new guidance issued by the US Food and Drug Administration earlier this month advises companies on how to treat polymorphic drug compounds?those that exhibit multiple structural forms?in filing abbreviated new drug applications.
A Perspective on Computer Validation
July 2nd 2007This article provides a historical review of computer validation in the pharmaceutical industry within the last three decades, evolving from the early years' initial concept and approach to today's current practices. Also included is how the regulations and industry have progressed in addressing the topic of computer validation.
Statistical Implications of the CGMPs: A 30-Year Retrospective
July 2nd 2007This article looks at the current good manufacturing practice regulations from a statistical perspective while addressing their requirements and implications and inviting the industry to assess its past performance in meeting the regulations.
The Evolution of FDA's Role in Ensuring Product Quality
July 2nd 2007The quality of a drug product is an essential element of drug safety and efficacy. With a statutory mission to provide safe and effective medications to the public, the US Food and Drug Administration has always focused on drug quality. The authors summarize the history of FDA's role in ensuring product quality and its role in shaping risk-based approaches to this goal.
Three Decades of Drug Regulation and Legislation
July 2nd 2007The US Food and Drug Administration has pursued many new initiatives since 1977. The agency began accepting abbreviated applications for generic versions of drugs, collected user fees to support drug review, launched the Critical Path Initiative to encourage innovation, and worked to harmonize its regulatory standards with those of Europe and Japan. New challenges such as AIDS and bioterrorism have affected regulatory policy in recent years. The author reviews FDA's changes in policy and philosophy during the past 30 years.
FDA Issues Draft Guidances for Online Access of Bioequivalence Studies for Generic Drugs
June 7th 2007Rockville, MD (May 31)-The US Food and Drug Administration issued a draft guidance on how to design bioequivalence (BE) studies for specific drug products to support abbreviated new drug applications (ANDAs).
Enforcing GMP compliance for APIs in EU medicines
June 1st 2007The Active Pharmaceutical Ingredients Committee (APIC) - a sector group of Conseil European des Federations de l'Industrie Chimique (CEFIC) - first voiced the need for EU GMP API legislation in 1993 to help ensure the safety of medicines. In 2000, the International Conference on Harmonisation (ICH) finalized the harmonized API GMP Guideline Q7, which became legal in the US and Japan in 2001. The EU adopted a directive in March 2004 that includes the requirement for APIs in medicines for the EU market to comply with ICH/Q7A. Member States are transposing the directive into their national law: about half of them have completed this process, seven more are well on their way to completion, while seven others are still in earlier stages of adoption.
A new system for the rapid transfer of sterile liquid through a containment wall
June 1st 2007Sterile 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.
Why biosimilars are not true generics
June 1st 2007It 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.
BIO Calls for 14-Year Data-Exclusivity Period for Biologics
May 10th 2007Washington, 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.