Column: Focus on Quality

Dec 01, 2014
Special Issues
The European regulations on good manufacturing practices (GMPs) — Annex 11 — are having a strong influence on good laboratory practice (GLP) and good clinical practice (GCP).
Nov 29, 2014
Spectroscopy
The European regulations on good manufacturing practices (GMPs) — Annex 11 — are having a strong influence on good laboratory practice (GLP) and good clinical practice (GCP).
Oct 29, 2014
Spectroscopy
Recently, regulators in both the United States and United Kingdom issued guidance concerning laboratory data integrity that followed serious noncompliances found during inspections. Here, we explore what this guidance means for spectroscopy systems used for analysis in regulated laboratories and derive some common-sense guidance that you can follow.
Sep 01, 2014
Spectroscopy
A closer look at the U.S. Pharmacopeial Convention's (USP) draft general chapter <1029> on good documentation practices.
Apr 01, 2014
Spectroscopy
A review of the United States Pharmacopeial Convention (USP) stimulus paper on the revision process to adopt quality-by-design principles for the development, validation, and operation of analytical procedures used for good manufacturing practice (GMP) analysis — and how it compares to a draft guidances by the Food and Drug Administration (FDA) for industry on validation of analytical and bioanalytical procedures.
Dec 01, 2013
Spectroscopy
When a laboratory — particularly a regulated GxP laboratory — contemplates using the cloud, finding a suitable supplier is critical
Nov 01, 2013
Spectroscopy
A risk assessment helps determine the amount of qualification and validation work necessary to show that instruments and computerized laboratory systems are fit for their intended purpose. Here's how to do it.
Sep 01, 2013
Spectroscopy
In pharmaceutical contract manufacturing, the work of analytical scientists is covered by a quality agreement, which is prepared by personnel in the quality control or quality assurance department and focuses on the laboratory analyses provided. But what exactly are quality agreements, why do we need them, who should be involved in writing them, and what should they contain? Here, we answer those questions.
Apr 01, 2013
Spectroscopy
A look at what the requirements are for "complete data" for laboratories working under the FDA GMP regulations. We also review the observations listed by inspectors on 483 forms from 2006 to 2012, to assess the common mistakes companies make.
Dec 01, 2012
Spectroscopy
Answers to common questions about operational qualification (OQ) software
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