Regulation: Standards, policy, compliance, and enforcement for good manufacturing practices and good laboratory practices - Pharmaceutical Technology

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Regulation
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.

Company and People Notes: GSK and Chroma Form Development Pact; Siemen's Healthcare Appoints US CEO; More...

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...

UK Strengthens Drug Supply Chain

Jul 2, 2009

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.

Cleaning Validation for Pharmaceutical Manufacturing

Jul 2, 2009

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.

US Marshalls Seize Caraco's Drug Products at Three Sites

Jul 2, 2009

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.

FTC Issues Report on Authorized Generics

Jul 2, 2009

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.

USP Collaborates with Asian Authorities

Jul 2, 2009

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.

Aqueous Cleaning for Pharmaceutical Applications

Jun 25, 2009

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.

Company and People Notes: Synta and GSK End Agreement; WuXi Appoints US VP; More...

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...

Sunshine Act Still Pending before Senate Committee

Jun 25, 2009

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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