Industry guidances and drafts by organizations like FDA, ICH, EMEA, USP & IPEC. Harmonization. Government policy. Validation, inspection, CGMP, imports & safety. Quality by Design (QbD), process analytical technology.
Jul 2, 2009
ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, Wyeth and Catalyst sign agreement; FDA seeks public opinion about tobacco regulation; Catalent appoints VP of quality and regulatory affairs; more...
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Jul 2, 2009
By:Stephanie Sutton
ePT--the Electronic Newsletter of Pharmaceutical Technology
The UK's Medicines and Healthcare Regulatory Agency (MHRA) has published the outcome of a consultation on measures to strengthen the country's drug supply chain.
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Jul 2, 2009
By:Malcolm McLaughlin, MS, Theresa Dowds, PhD
Pharmaceutical manufacturers must validate cleaning processes and be compliant with current good manufacturing practices for finished pharmaceuticals as stated in 21 CFR Subpart D 211.67—equipment cleaning and maintenance. Validation is a documented guarantee that cleaning can be performed reliably and repeatedly to satisfy a predetermined level of cleanliness. This whitepaper addresses residue identification, residue detection method selection, sampling method selection, setting residue acceptance criteria, recovery studies, writing procedures and training operators.
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Jul 2, 2009
By:Maribel Rios
ePT--the Electronic Newsletter of Pharmaceutical Technology
On June 25, US Marshalls seized all drug products and ingredients at three facilities of Caraco Pharmaceutical Laboratories.
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Jul 2, 2009
By:Patricia Van Arnum
ePT--the Electronic Newsletter of Pharmaceutical Technology
The Federal Trade Commission (FTC) last week issued an interim report that examined the effects of authorized generics on competition in the prescription drug market.
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Jul 2, 2009
By:Erik Greb
ePT--the Electronic Newsletter of Pharmaceutical Technology
This week, the US Pharmacopeial Convention and the Vietnamese Pharmacopoeia Commission signed a memorandum of understanding that will help ensure the safety of Vietnamese medicines.
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Jun 25, 2009
By:Malcolm McLaughlin, MS, Alan S. Zisman, MD, Technical Services Staff, Alconox Inc.
To streamline regulatory compliance, the desirability of using as few cleaners as possible to remove the entire range of residues encountered in pharmaceutical manufacturing — from water-soluble excipients to difficult-to-clean petrolatum/metal oxide mixtures — is explored in the standard industry text, The Aqueous Cleaning Handbook. Cleaning validation guidelines and key factors in establishing sound GMP and cGMP procedures are discussed. Explaining how aqueous cleaners work in a wide range of cleaning procedures, the text covers manual, soak and ultrasonic cleaning as well as clean-in-place (CIP) spray systems. Tables for chemical formulations, types of cleaning methods, and aqueous cleaning agents are included. A useful, in-depth reference whether you are cleaning bench scale lab apparatus used for trials to full-scale bulk manufacturing equipment.
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Jun 25, 2009
ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, Adimab forms deals with Merck and Roche; Manhattan Pharmaceuticals' CEO and president steps down; more...
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Jun 25, 2009
By:Erik Greb
ePT--the Electronic Newsletter of Pharmaceutical Technology
The Physician Payments Sunshine Act is still pending before the US Senate Committee on Finance, according to Jill Kozeny, communications director for Senator Chuck Grassley (R-IA).
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