DCAT Week ’15, organized by the Drug, Chemical & Associated Technologies Association, was held March 16-19, at the Waldorf Astoria in New York. The event hosted pharma/biopharma companies, service providers and member companies, and the hotel lobby was buzzing with meetings throughout the event. Also, several sessions addressed key industry topics, namely, the FDA’s Quality Metrics initiative. Below are some session highlights along with an interview on API sourcing trends.
 
The session entitled “Quality Metrics: The FDA’s Initiative and Its Impact on Pharma Manufacturers and Suppliers,” addressed the latest progress on the FDA’s quality metrics initiative and its impact on pharma manufacturing. Speakers included: Alex Viehmann, Statistician, Center for Drug Evaluation and Research / Office of Surveillance, Quality Intelligence Branch, U.S. FDA, and Frances Zipp, President, Lachman Consultants.
 
The FDA continues to place an emphasis on surveillance for now, but will develop and manage an analytics and prediction program that will create a new inspection paradigm and assessment, according to FDA’s Alex Viehmann. He noted this program will not just seek out the bad, but also those companies performing well, with quality product and facilities. Ultimately, the goal is to leverage this information to help the industry succeed.
 
The FDA plans to handle the program similar to the SATs, and is intended to engage stakeholders. While the information obtained will not be made public, purchasers can request information from the FDA about a manufacturer.
 
Challenges
In the meantime, clear and common definitions are essential to drive the program forward. Mr. Viehmann noted that language variability creates the greatest challenge. Further, there are foreign/domestic language barriers across the scope of various segments, such as brand, generic, bio, OTC, solid, oral, liquid, sterile, etc.
 
Ensuring appropriate use of metrics is intended to enhance FDA analysis, and to date, the FDA has received metrics applicable to these numerous sectors from organizations including BIO, PDA, ISPE, CHPA, PhRMA, etc., and expects further guidance coming down the pipeline soon (a specific timeline was not given).
 
Program Objectives
·      Use quality metrics to select sites for reduced inspection frequency
·      Monitor product quality
·      Estimate baselines and when and if there is a chance of filing
 
Under the authority FDASIA title VII section 706, components of metrics will be collected by product application level from the sponsor, by site. These components include ranges, averages, cross signals, the impacts of non-reporting, regulatory risk score, and import alerts. The FDA has to determine the issues and notably, according to Mr. Viehmann, what correlation, if any, exists between metrics.
 
The FDA’s Potential Questions to Explore
What effect does process segment (e.g. biologic, synthetic) have on the outcome of each metric? For example, are we observing significantly different OOS rates across industry segments?
 
What effect does dosage form or activity (API, FDF, packaging) have on the outcome of each metric?
 
What effect does each metric have on drug recalls (past, present or future)?
 
What effect does each metric have on compliance status (NAI, VAI, OAI consent decree, etc.)?
 
What effect does time post-approval have on the outcome of each metric?
 
What correlations, if any, exist between metrics?
 
Do metric interactions exist?
 
Early Pilot Findings
While there’s still some confusion regarding the FDA Quality Metrics initiative, and it’s a little behind on the guidance, people should be happy it’s late, according to Frances Zipp of Lachman Consultants. She noted, there has been great dialogue, particularly on how to handle data. The guiding principals of which are—easy to capture, easy to report.
 
Ms. Zipp emphasized that culture and behavior are critical with quality metrics, as not every decision by every person in a company is documented. The goal is to drive acceptable, NOT unacceptable behaviors.
 
With the pilot program under way, she notes the resulting information has been “enlightening”, regardless of whether or not the companies like what was found; the data is meaningful. While the objectives were not specifically met, that doesn’t mean it wasn’t successful, says Ms. Zipp.
 
In order to handle the metrics, you need mature data systems, along with frequent, transparent discussions at your site, says Ms. Zipp. You also need to understand how data is collected and the underlying factors. Again, Ms. Zipp notes that culture is key here. Additional details regarding Measuring Quality Performance can be found in the April issue of Contract Pharma.
 
DCAT is a non-profit global business development association for the pharmaceutical manufacturing industry.

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API Sourcing Trends In a Challenging Environment
 
Ed Price of PCI Synthesis addresses trends, regulatory and supply chain hurdles, and quality concerns
 
Globalization in the pharma and biopharma industry has contributed to an increasingly complex supply chain fraught with numerous challenges. And, outsourcing to emerging markets of India and China, for example, have led to increased regulatory scrutiny following numerous incidents of contaminated raw materials. Since then, APIs sourced from these, and other countries, have been subject to increased testing and regulatory inspections. Today, concerns about the supply chain and drug quality persist.
 
PCI Synthesis, a manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products, based in the greater Boston area, provides a domestic perspective. Contract Pharma spoke with Ed Price, the company’s president and chief executive officer, to discuss the latest API sourcing trends, regulatory and supply chain hurdles, and quality concerns. -KB
 
To read the full interview, click here.