GMP NEWS 2016

A news in June 2014 already reported about the APIC "Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredients Plants". Now, a revision has brought the APIC guidance in line with EMA's guideline on "Shared Facilities".

A new USP monograph for HPMC or veggie capsules has been proposed in the Pharmacopeial Forum. Read more about the proposed USP monograph for Hypromellose Capsule shells.

EMA's GMP/GDP Inspectors Working Group has published the 2015 annual report summarising its activities.

The FDA draft guidance for combination products has a substantial impact on the development of Oral Inhalation and Nasal Drug Products (OINDPs) as it requires that the manufacturers have to be compliant not only with CGMPs for the drugs (21 CFR Parts 210 and 211) but also with the quality system (QS) regulations for devices (21 CFR Part 820). Find out more about the FDA Draft Guidance for Combination Products.

The FDA published the final version of the Guidance for Industry" Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)".

The U.K. MHRA has published a blog and gives some insight in an audit performed as part of the Joint Audit Programme (JAP) for EEA GMP Inspectorates.

Water is an essential raw material in pharmaceutical production. It is with great effort that the required qualities (such as WFI or AP) are produced and maintained in storage and distribution systems. However, it is often neglected which impurities in the raw water are relevant for the production of pharmaceutical water. Yet this knowledge is crucial for the design of a water purification plant and for the validation of the complete system.

ICH Q10 was published in its final version already in 2008. However, today many companies still have problems to understand how to implement ICH Q10 "Pharmaceutical Quality System" into practice. Quality Assurance and GMP are basic requirements which have been implemented for many years in the pharmaceutical industry (including the API industry). So what is needed to demonstrate that a Pharmaceutical Quality System has been implemented? Please read more about the GMP Questions and Answers.

The news on the Medical Devices Warning Letter Statistics 2015 - What the FDA criticizes at Medical Device Manufacturers from 2 December 2015 already reported about the FDA statistics from 2015 respectively about the Warning Letters Medical Device Manufacturers received. Read more about the latest developments - with regard to medical devices - in the top 5 list for the fiscal year (FY) 2016 (1 October 2015 to 30 September 2016, as of 3 October 2016).