Top regulation & enforcement articles of

2010
By Nick Taylor, 23-Dec-2010
Related topics: Contract services (outsourcing), Ingredients, excipients and raw materials,
QA/QC & validation, Processing & QC, Globalisation
Regulations and enforcement were big topics yet again in 2010. in-PharmaTechnologist
presents five of our most read on the topics, covering starting material quality and overseas
inspections.
WHO drafts guidelines on starting material quality
The World Health Organization (WHO) issued draft guidance on the production of starting
materials in March. Focusing on materials used as, or in the production of, active pharmaceutical
ingredients (API), the WHO sought to ensure quality without overburdening manufacturers.
Burdensome regulation of stating materials could drive up prices and lead to people using
counterfeit or substandard drugs and ingredients. Consequently, the WHO recommended a risk-
based approach, as opposed to uniform application of good manufacturing practices (GMP).
FDA may never have inspected 88 per cent of Chinese sites
The US Food and Drug Administration (FDA) may never have inspected 88 per cent of the 920
Chinese facilities in its inventory, according to the US Government Accountability Office
(GAO).
Figures for inspections of China-based sites were published in a GAO report looking at progress
made by the FDA since its 2008 assessment . The GAO said: “There is an urgent need for FDA
to better protect the public health by implementing our prior recommendations.”
EU revives GMP for excipients
In February the European Fine Chemicals Group (EFCG) told in-PharmaTechnologist it
welcomed the inclusion of GMP requirements for excipients in the falsified medicines directive.
Last year the European Commission (EC) stopped work on a GMP directive for some excipients.
Alexandra Brand, an EFCG board member, told in-PharmaTechnologist legislation should be
risk-based and ensure patient safety without subjecting excipient manufacturers to unnecessary
burdens.
FDA may be having difficulties in Puerto Rico, says US oversight committee
Congressmen questioned whether the FDA is “having difficulty” in Puerto Rico in a letter sent to
Commissioner Margaret Hamburg. Facilities in Puerto Rico have been linked to a number of
quality control issues over the past 12 months.
“The FDA’s Puerto Rico district office may be having difficulty exercising oversight on the
numerous pharmaceutical manufacturing facilities on the island”, said the letter.
EMA, FDA seek applicants for joint GMP inspections
This year the FDA and European Medicines Agency (EMA) began seeking applicants for a joint
GMP inspection pilot programme. Regulators hope joint inspections will improve use of limited
resources and are now testing the concept on companies seeking pre-approval in both countries.