Regulatory/GMP Compliance

Cases of overlooking proper packaging, reconstitution, directions, and dissolution.

The recent amendment to Annex 1 has seen controversial changes relating to the capping of vials.

New isolator and disposable technologies are set to assume a greater role in pharma manufacturing, according to a recent conference in Germany.

Changes to Part 2 of the EU GMP guide will come into force by 31 July 2010 in order to bring it in line with the ICH Q9 guideline on Quality Risk Management. As a result, it will no longer be identical to the ICH Q7 guideline on APIs - a harmonised guideline for the US, Europe and Japan.

Reports of overlooked controls, dropped pallets, and misplaced documents leave a chill in the air.

The US Food and Drug Administration issued on June 25 a draft guidance for industry, "CMC Postapproval Manufacturing Changes Reportable in Annual Reports," to provide recommendations to drug applicants about the types of changes that may be included in annual reports.

Europe needs a more standardised and consistent approach for supplying excipient information to the regulators.

Too much or too little control can actually lead to the same result.

The authors recommend a strategy for classifying similar nonstainless-steel surfaces into three groups based upon the analytical recovery that was observed in this study.

An effective quality management system will identify the root cause of non-conformances and put measures in place to ensure that they do not recur, but is the pharmaceutical industry choosing the right methods to make sure this happens?

A book helps statistics novices prepare to comply with the US Food and Drug Administration's draft guidance on process validation.

When vessels, seals, and cooling units go haywire, operators must get in the mix.

The author describes the new IPEA excipient good-manufacturing-practice certification program that is now ANSI accredited. This article is part of a special issue on excipients and solid dosage.

New Draft Guidance for Solid Oral Dosage Forms Focuses on Physical Chemical Identifiers. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

FDA made available a draft guidance that would expand the information disclosed about conflict-of-interest waivers.

Laboratory personnel share interesting tales as well as stories of unexpected tails.

In an attempt to strengthen safeguards against counterfeit, diverted, subpotent, misbranded, adulterated, or expired drugs, FDA issued a new final guidance for industry.

FDA issued a new guidance for industry to help new drug applicants write the dosage and administration section of their products' labels.

The US Food and Drug Administration recently published guidance for the characterization and qualification of cell substrates, viral seeds, and other biological materials used to manufacture viral vaccines for human use.

From last-minute product inserts to putting out fires, close calls are a common occurrence.

FDA Releases Annual Guidance Agenda; OMB Urges Obama to Issue Revised Executive Order.

Sharing too much-or too little-information can have disastrous onsequences.

New York Governor Wants Stricter Limits On Pharmaceutical Marketing; And More.

Directors and staff miss the mark when it comes to following procedures.

Blame it on cafeteria gossip, outdated procedures, and major miscommunication.

Also, FDA and WebMD increase collaboration and PPD is awarded contract to evaluate the agency's postmarket spontaneous-adverse-event surveillance system.

New tests solve one issue, but cheaper plastic and new stoppers cause problems.

The US Food and Drug Administration issued a guidance for industry and review staff titled, Labeling for Human Prescription Drug and Biological Products-Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information.

The US Food and Drug Administration published its first draft guidance for industry about Risk Evaluation and Mitigation Strategies (REMS) on Sept. 30, 2009.

Like life, the workplace also can have many surprises.