The FDA has published an independent industry guideline on product recalls, biological and medical devices. The guideline describes deficiencies which refer to regulations like for example the GMPs. Sometimes, recalls are made to serve product enhancement. In order to clearly distinguish product recalls from product enhancements, the FDA published at the end of February a draft guideline. Read more here.
The Brazilian monitoring authority ANVISA has integrated an inspection check list to the GMP guideline for medical devices. As these GMP requirements are very similar to the US American ones (21 CFR 820, Quality System Regulations, QSR), this inspection check list may also be useful for companies who want to export in the USA. Read more here.
FDA's Center for Devices and Radiological Health (CDRH) published its strategic objectives regarding medical devices for 2013 in a document entitled "2013 Strategic Priorities". The document is composed of 12 pages which ... read more.
Have you also always wondered how the FDA gets its guidelines? As concerns GMP documents on the regulation of medical devices the "Device Good Manufacturing Practice Advisory Committee" (DGMPAC) plays an important role. It is the ... read more.
To find out how pharmaceutical companies in the EU are seeing the challenges with the Written Confirmations, the European QP Association conducted a brief survey amongst its members beginning of this year. Almost 300 QPs gave answers to the questions. Read more.
From a regulatory point of view, essential oils used as APIs in herbal products raise a broad range of questions. Currently, there is no EMA/HMPC Guideline on the topic. A "Reflection Paper" from 15 January 2013 invites interested stakeholders to express their opinion. Further details can be found here in the News.
An FDA Warning Letter dated February 2013 describes deviations identified during the inspection of an US-American company. Apart from the failure to adequately investigate and document OOS test results, failures in the stability program and deviations in the water purification are the main content. Read more.
Submitting an application for a centrally authorised product is a complex procedure. Now the EMA has simplified this procedure through new regulations and presented them in an updated guide. Read more here.
From time to time the Parenteral Drug Association (PDA) releases so-called "Technical Reports" (TR) on GMP topics. They provide useful and up-to-date information on the respective topic. The newly published Technical Report No. 60 deals with the topic "Process Validation". Read more here.
In February, the World Health Organisation (WHO) published a draft for a new guideline that gives assistance in designing studies for establishing hold times of intermediate and bulk products prior to packaging in the final containers. Read more.
In February, the Paul-Ehrlich-Institut published a notification on "Imposition of conditions pursuant to Section 28 (3) c AMG (Arzneimittelgesetz, German Medicines Act) for the purpose of risk prevention to assure the safety of blood components for transfusion and of stem cell products for haematopoetic reconstitution: Testing for HIV, HBV and HCV". Read more.
In March 2013, the FDA published a draft guidance "Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis". For more details read here.
The FDA updated the ongoing Chapter 42 - Blood and Blood Products Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors- 7342.001 of the Compliance Program Guidance Manual. Get more details.
One often wonders which differences do exist between the US American cGMP regulations (21 CFR 211) and the EU GMP Guide - and which parallels they have. What's the place for ISO 9001 in these phama specific regulations? In order to support answering the questions, the ECA developed a Good Practice Guide "GMP Matrix" a few years ago. Now, this matrix has been completely revised. Read more.
Together with the EMA Process Validation Guideline the Annex 15 should also be revised. A very vague concept paper is available which the EMA is requesting comments for. Now we would be interested in finding out what your thoughts are with regard to the planned revision. For that purpose the ECA has prepared a brief questionnaire. Read more.
In the context of cleaning validation reference is often made to the riboflavin test when it comes to wettability and spray shadows. But how is the test carried out exactly? Are there any alternatives to this test? Read more.