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An introduction is presented in which the editor discusses various reports within the issue including human error as a citation among companies as a cause of deviation with a subsequent corrective and preventive action, a review of the new European Medicines Agency (EMA) Draft Guideline on Sterilisation of the Medicinal Product and anti-counterfeiting and sterilisation issue.

A table is presented that summarises the status of all the parts of set of updated ISO 14644 series of standards for cleanrooms and associated clean environments including classification of air cleanliness, test methods and biocontamination control. It also mentions a concept paper issued by European Medicines Agency recommending the revision of the Annexure 1 of the European Union (EU) Good Manufacturing Practices (GMP) Guidelines on the manufacturing of sterile products.

The article discusses the development in the regulations in the pharmaceutical industry. It talks about the European Medicines Agency's (EMA) mission to protect human and animal health, and also ensure safe access to quality medicines. It states that implementation of Good Manufacturing Practice (GMP) has to be ensured. It is noted that the U.S. Food and Drug Administration (FDA) is amending its regulations on drug establishment registration and listing.

The article offers information on developments in the regulations of the pharmaceutical industry. Topics discussed include the European Medicines Agency starting to review the guidelines that describe first-in-human clinical trials and the data needed to enable their appropriate design and allow initiation, the EU Good Manufactuing Practices needed for sterilisation processes of primary packaging and introduction and implementation of safety features on packaging.

The article outlines some regulatory updates for pharmaceutical industries in the European Union (EU) and the U.S. as of January 2016. Topics discussed include the agreement signed by the European Medicines Agency and the World Health Organization (WHO) to share confidential information to protect global public health, and regulations related to Qualified Persons. Also mentioned is the U.S. Food and Drug Administration directive that revises permitted daily exposure of workers to solvents.