FDA´s Drug Safety Draft Guidance regarding REMS

The Food and Drug Administration (FDA) published a draft drug safety guidance for industry for comment. Read more about "FDA´s application of statutory factors in determining when a REMS is necessary".


FDA Guideline on "Microbiology Data for Systemic Antibacterial Drugs - Development, Analysis, and Presentation"

To assist pharmaceutical manufactureres in the development, analysis, and presentation of microbiology data during antibacterial drug development, the FDA published a guideline on "Microbiology Data for Systemic Antibacterial Drugs - Development, Analysis, and Presentation".


APIC updates its Guidance on Cleaning Validation with regard to the PDE Concept

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".


Comprehensive Overview of global Initiatives on Medicine Regulation published

The EMA has published an overview of existing international regulatory initiatives for human medicines, like for example ICH,PIC/S, IPRF and ICMRA members.


New USP monograph for Hypromellose Capsule shells (HPMC or veggie capsules)

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.


The Risk of Biofilm

Even in well-maintained water systems, repeated sudden and brief OOS/OOT results can occur in the microbiological monitoring. If we talk about typical water bacteria, biofilms in the systems are almost always responsible for these results. Read more about the risk of biofilms.


Annual Report of the GMP/GDP Inspectors Working Group published

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


FDA presentation at the ECA Conference Particles in Parenterals

At the Particles in Parenterals Conference Dr Stephen Langille from the US FDA gave a talk on the FDA's current thinking with regard to the visual inspection of medicinal products for parenteral use.


The impact of the FDA Combination Products Guidance on Nasal and Oral Inhalation Drug Products

The FDA draft guidance for combination products has a substantial impact on the development of Oral Inhalation and Nasal Drug Products (OINDPs) as it requires that the manufacturers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.


Counterfeit of medicines causes 37,000 job losses in EU Pharma Industry

Counterfeit medicine is an increasing problem for public health and economy. This is no longer a problem of certain regions such as Asia and Africa. It has now also become an issue in the EU and US. The European Union Intellectual Property Office (EUIPO) published a press release on 29 September 2016 in which they state that fake medicines cost the EU pharmaceutical sector 10.2 billion Euro every year. Read more about the latest figures on counterfeit medicines


Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus

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)".


FDA Updates on Multistate Outbreak of Burkholderia cepacia Infections

An FDA investigation associated with a multistate outbreak has identified the bacteria Burkholderia cepacia in more than 10 lots of oral liquid docusate sodium manufactured. More details at the FDA Updates on Multistate Outbreak of Burkholderia cepacia Infections.


Who inspects the Inspectors?

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.


Ph. Eur. Draft Chapter 3.2.1 "Glass containers for pharmaceutical use"

A draft of a revised version of the European Phramacopoeia general chapter on glass containers has been published for comment. Read more about the Ph. Eur. draft general chapter 3.2.1 "Glass Containers for Pharmaceutical Use".


Critical Impurities in Pharmaceutical Water

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.


What are the GMP Responsibilities of the Marketing Authorisation Holders?

The European Medicines Agency (EMA) has published a concept paper to summarise the GMP responsibilities of the Marketing Authorisation Holders (MAH).


How does a company demonstrate the implementation of PQS in accordance with ICH?

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.


USP Draft Chapter <1062> "Tablet Compression Characterization"

The USP General Chapters—Physical Analysis Expert Committee proposes a new general chapter to describe the basic principles and practices used in the characterization of tablet compression. Read more about the proposed new USP chapter <1062> Tablet Compression Characterization.


FDA Warning Letter Statistics for the Fiscal Year 2016 - CAPA still on Place 1

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).


GDUFA: FDA's new Guidance on Self-Identification of Generic Drug Manufacturers

FDA's new Guidance requesting generic drug manufacturers who want to export to the USA to self-identify has recently been published in a finalised form. Read more here about what types of generic drug manufacturers are affected and which company data are required by the FDA.


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