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IPEC Continues to Urge Family Approach in Dialogue with FDA on Improving Inactive Ingredient Database

IPEC-Americas and the Generic Pharmaceutical Association (GPhA) are continuing their advocacy of FDA incorporating a family approach in the toxicology assessment of excipients as they work with the agency on further improving the inactive ingredient database (IID) to support better drug development and more efficient FDA reviews.

PIC/S Relationship is Impacting Process Validation Expectations in Asia Pacific Region, Although They Vary in Practice, ISPE’s Asia Network is Reporting

The strong influence of PIC/S in the Asia Pacific region is impacting the expectations for process validation, although those expectations vary significantly in practice, the ISPE Asia network is reporting.  

Clarifying Questions Upfront is Key in Process Validation, US and EU PV Principles in Alignment, CDER’s McNally Stresses 

FDA is advising industry to ensure that their process validation teams clearly articulate and document the questions they are seeking to answer up front, prior to collecting data or executing process qualification (PQ).

Phased Implementation, Reporting Burden Among Industry Focal Points in Initial Feedback on FDA’s Quality Metrics Draft Guidance

Phased implementation, reporting burden, and the nuances of site versus product reporting were among the focal points of the comments by the various associations appearing at the public meeting held by FDA on August 24 to capture industry’s initial feedback on the agency’s quality metrics draft guidance.

Relationship with Excipient Providers Drawing Increasing Pharma Attention, BMS Exec Stresses; IPEC Urges Regulatory Pathway for New Excipients in GDUFA/PDUFA Comments

An important component in the ability of pharmaceutical innovators to bring their new products to market in the eclipsed timelines in which they need to function will be their relationship with excipient providers, a top manufacturing executive from Bristol-Myers Squibb (BMS) stressed to participants at the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas)/ExcipientFest conference […]

IPQ Monthly Update, June 2015

In focus are: ● FDA’s CDER on the role of the control strategy in application approval recommendations and the challenges reviewers face in piecing the story together ● the key role a novel excipient played in the development of a new insulin inhalation product and the broader implications of the experience, and ● ICH’s effort to address the pressing questions on API CMC and GMP through Q&As on Q7 and Q11....

ICH’s API Coverage Deepening with a Newly Released Q&A on Q7 and a Q11 Q&A Project on Starting Materials Underway

A newly released Q&A from ICH on its active pharmaceutical ingredient (API) GMP guideline Q7 and another Q&A being prepared on the more recently issued API development and submission guideline Q11 are intended to address issues that have surfaced in implementing the two guidelines and drive more uniform interpretation across industry and regulators worldwide....

International Counterfeit Medicines Effort

In Mid-June, FDA, in partnership with international regulatory and law enforcement agencies, took action against more than 1,050 websites that illegally sell potentially dangerous, unapproved prescription medicines and medical devices to consumers. These actions include the issuance of regulatory warnings to the operators of offending websites and seizure of illegal medicines and medical devices worldwide. […]

WHO Guideline for Hold-Time Studies

The World Health Organization (WHO) released a final guideline on “storage and transportation of time- and temperature-sensitive pharmaceutical products.” Included is guidance on storage conditions for raw materials, packaging materials, intermediate, bulk and finished products, and on maximum hold-times for intermediate and bulk products prior to their further processing.

Indian Agency Counterfeit Drug Effort

India’s Central Drugs and Standard Control Organization (CDSCO) is in the process of sampling drugs on the market in India to determine what percentage of those are counterfeit, Indian Express reports. To date, about 50,000 samples from Indian manufac-turers have been collected. CDSCO plans to issue a report on the effort by the end of […]
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