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EDQM’s Efforts to Clarify Starting Material Expectations Include Internal Policy Guide; SM Dialogue Continues

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has been working hard to better define its policies around starting materials in view of their impact on the regulation of active pharmaceutical ingredients (APIs)....

Look Forward, Not Backward, in API Process for Impurity Risks, Industry Experts Urge EU Regulators

API industry experts are urging European regulators to focus on the risks from impurities that enter at the end of the API synthesis process rather than on earlier pre-intermediate stages where the risks may be considerably less and fully mitigated by later processing....

ICH Q11 Nears Final Approval After Comments Prompt Changes in Step 2 Draft

The final version of ICH’s drug substance development and manufacturing guideline Q11 is nearing Step 4 clearance by the regulatory agencies in the three ICH regions following some significant changes the Expert Working Group (EWG) has made to the Step 2 draft based on the comments received....

OOS Result Handling Continues as Dominant Theme in FDA Warning Letters Issued Abroad

Giving adequate attention to out-of-specification (OOS) results in batch release decision making and investigation follow up continues as the dominant theme in 2011 in GMP warning letters issued to foreign companies by FDA’s drug and biologic compliance offices....

Warning Letter to API Contract Testing Lab Cites Data Misrepresentation to Customers

A recent FDA warning letter to US-based API contract testing lab Toxin Technologies highlights the agency’s ongoing concern with the communication between contractors and their customers....

Lab Data Integrity at Issue in FDA Warning Letters Sent to China and India

Evidence of unreliable laboratory data has prompted the Office of Compliance at FDA’s Center for Drug Evaluation and Research (CDER) to issue warning letters over the past few months to drug manufacturers in China and India....

Heparin API Manufacturer SPL Draws Warning for Complaint Handling and Supplier Auditing

Inadequate follow up to customer complaints – a key theme in recent FDA drug GMP warning letters – was again on the front burner in a warning letter issued in late January to Scientific Protein Laboratories (SPL) in the wake of the agency’s continuing investigation into the 2008 heparin contamination crisis....

Value of Attribute Risk Ranking in Process Development Recognized by ICH Q11 EWG

The current working draft of ICH Q11 promotes the use of risk ranking of quality attributes as a valuable tool in applying quality-by-design (QbD) principles to biotech drug substance development and manufacturing....

ICH Q11 Process Validation Discussion Will Be at High Level Given Guideline’s Scope

The ICH Q11 Expert Working Group (EWG) is settling on a high level approach to addressing process validation in its drug substance development and manufacturing guideline, reflecting the challenges of encompassing drug and biotech products and the evolving expectations across the three regions....

ICH Q11 Draft Gelling On Lifecycle/Change Management and Control Strategy Components

The lifecycle management section of the newest working draft of ICH’s Q11 guideline on drug substance development and manufacturing provides allowance for applicants to include change management proposals in their original submissions....
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