IPEC Insider

ExcipientFest 2013 Presentations Now Posted

16 May 2013 13:32:42 CDT

Presentations from FDA, USP, industry, regulatory, scientific and technical now posted!

More than 20 in-depth presentations on trends in excipient technology, new drug applications, regulatory and sourcing strategies from the April 30 - May 1 ExcipientFest Americas, Renaissance HarborPlace Hotel, Baltimore.

Letter of Intent

16 May 2013 13:32:42 CDT

The International Pharmaceutical Excipient Council of the Americas, (IPEC-Americas) has signed a letter of intent to sell its wholly owned subsidiary third party auditing program, IPEA (International Pharmaceutical Excipients Auditing) and its ANSI accredited Excipient GMP Conformance Certification program to NSF International. The sale is expected to be finalized during the 2nd-3rd quarter of 2013.

USP Excipients Stakeholder Forum Scheduled for June 7, 2013, Rockville, Md., and via the Web

16 May 2013 13:32:42 CDT

The United States Pharmacopeial Convention (USP) will be holding the first Excipients Stakeholder Forum on June 7, at USP's Rockville, Md., headquarters. To expand the opportunity for stakeholder participation, USP will offer a web-based component for those who would like to attend the meeting remotely. Registration is free for both in person and remote attendance. Priscilla Zawislak, IPEC-Americas Vice Chair, Compendial Review/Harmonization will serve as chair of the event.

IPEC-Americas Welcomes New Member — Henkel

16 May 2013 13:32:42 CDT

Henkel operates worldwide with leading brands and technologies in three business areas: Laundry and home care, beauty care and adhesive technologies. Founded in 1876, Henkel holds globally leading market positions both in the consumer and industrial businesses with well-known brands such as Persil, Schwarzkopf and Loctite.

Prescription/Nonprescription Stakeholder Forum Scheduled for June 11, 2013 in Rockville, Md., and via the Web; Agenda Topics Sought

16 May 2013 13:32:42 CDT

The United States Pharmacopeia (USP) will be holding the Prescription/Nonprescription Stakeholder Forum on June 11, 2013 at USP's Rockville, Md., headquarters. To expand the opportunity for stakeholder participation, USP will offer a web-based component for those who would like to attend the meeting remotely.

IPEC-Americas Excipient GMP Auditing Workshop

16 May 2013 13:32:42 CDT

Oct. 22-24, 2013
Space is limited to 20 participants — register now!

Workshop Overview

Assessing GMPs for Excipient Manufacture

Where GMPs Begin

Audit Planning

Pre-audit Questionnaires

Alternative Audit Approaches

Audit Checklists and Techniques

Necessary Auditing Interpersonal Skills

Defining Pertinent Audit Issues In Observations

Writing and Rating Observations

Excipient Manufacture Requirements vs. APIs

Hands-On Mock GMP Audit

The International GMP and GDP Certification Scheme for Pharmaceutical Excipients is Launched in the US

16 May 2013 13:32:42 CDT

IPEC-Americas is pleased to announce the successful U.S. launch of EXCiPACT™, a voluntary international certification scheme designed and developed to assure cGMP and cGDP standards are being used in the manufacture and supply of pharmaceutical excipients.

Don't Miss Out on Crucial Information at the 2013 PDA FDA Pharmaceutical Supply Chain Workshop!

16 May 2013 13:32:42 CDT

The 2013 PDA/FDA Pharmaceutical Supply Chain Workshop will explore and address the benefits of modernization and innovation, as well as the ongoing challenges of supplier and contractor management. The workshop will also expound upon crucial information such as Import Compliance; FDA's key initiatives on the Asia Pacific Economic Cooperation (APEC); California Board of Pharmacy E-Pedigree Regulation which goes into effect in 2015; and U.S. Customs and Border Protection's Pharmaceutical Center for Excellence and Expertise Efforts with FDA.

Coalition Calls for Science-Based Approach to Elemental Impurity Testing

16 May 2013 13:32:42 CDT

David Schoneker, a chairman for the Coalition of Rational Impurities Requirements said that industry is concerned by a May 2014 deadline set by USP for implementing its General Chapters on elemental impurities while ICH is working on its own separate technical requirements. Once ICH began working on this it was expected the governing body to develop the elemental impurity limits while the pharmacopeias would be working on methodology.

US FDA Issues Norms on Regulatory Classification of Pharmaceutical Co-Crystals

16 May 2013 13:32:42 CDT

US Food and Drug Administration (FDA) has now issued guidance on Regulatory Classification of Pharmaceutical Co-Crystals. It provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) on the required data to be submitted to support the appropriate classification of a co-crystal, as well as the regulatory implications of the classification.The recommendations in the guidance apply to materials that the US FDA has not previously evaluated and determined to be pharmaceutical co-crystals. It does not apply to materials that the regulatory authority had previously designated as salts, complexes, or other non-co-crystalline forms.

Easing of Regulations Encourages Renaissance in New Drugs for Rare Diseases

16 May 2013 13:32:42 CDT

Once famously described as "orphan diseases, too small to be noticed, too small to be funded" in the Hollywood drama Lorenzo's Oil, rare diseases are getting unprecedented attention among drug manufacturers, who are ramping up research efforts and marketing new medicines that promise fuller lives for children and other patients with these heartbreaking conditions.

Ranbaxy Pleads Guilty to Manufacturing Adulterated Drugs

16 May 2013 13:32:42 CDT

In the largest US generic drug safety settlement ever, Ranbaxy USA has agreed to pay $500 million after pleading guilty to manufacturing and distributing adulterated drugs, according to the U.S. Justice Department settlement agreement. The company plead guilty to three felony Federal Food Drug and Cosmetic Act counts and four felony counts of knowingly making material false statements to the FDA.