IPQ Monthly Update — March 2012 in Review

IPQ’s March Monthly Update includes in-depth coverage of several important initiatives underway in the US, Europe and ICH to clarify and harmonize the regulatory expectations for API control across the drug and biotech spectrum.

In one story, IPQ delves into the API guidance efforts that are moving forward at the EMA and ICH levels on issues such as active substance master files, heavy metals and antibiotic impurities.

In a second group of stories, the March issue takes a deep dive into the efforts in Europe and the US to clarify and refine the expectations for upstream API control. Explored are:

● the efforts by EDQM to better define its starting material policies and the reasons for the intensity of the industry concern that the issues involved engender

● a compelling rationale presented recently by an industry expert for why regulators should focus more on the risks at the end of the API synthesis and leave industry with some upstream flexibility, and

● the new FDA and EMA guidances on crude heparin testing and supply chain control expectations, reflecting the regulator concern with upstream API manufacturing and supply – particularly with biologically-derived products – driven by the heparin crisis.

The March Update also focuses on the hard look that the US and European pharmacopeias are taking at how they can help assure the quality of biotech products without constricting the rapidly moving bioscience and technology.

Moving to the GMP side of the equation for oral solid dosage forms, the issue includes an in-depth analysis of the causes of an upsurge over the past few years in recalls of overweight tablets and the FDA insights provided in a recent warning letter focused on the GMP issues behind one firm’s problems with tablet production.

Induced in part by the GMP problems that generic injectable manufacturers have been experiencing lately, drug shortages remain in the spotlight across the government, industry, healthcare and patient advocacy community. IPQ coverage continues with a focus on the additional steps FDA has announced to increase the availability from alternative sources of critically needed cancer drugs in short supply and the new instructions the agency has issued on reporting events that may lead to product shortages.

The lead story in the March issue highlights a compelling speech by FDA Commissioner Hamburg on the critical role the agency plays in fostering innovation and its current efforts to advance regulatory science to support a more flexible and innovation-friendly regulatory process in the future.

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