FDA Draft Guideline on reporting Changes to an approved Application

At the end of last year, the FDA published a revision draft for their guideline "Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products" which is supposed to take account of the current standards of risk assessment and the submitted data of past change notifications.


FDA publishes Questions and Answers on Pathogen Reduction in Blood Components

With their new questions and answers paper, the FDA wants to provide further information on the implementation of pathogen reduction techniques for blood establishments.


FDA revises Guideline on HIV and HCV Testing for the Assessment of Blood Donors

With an update of their guideline on NAT testing of blood and plasma donations for HIV-1 and HCV, the FDA takes account of the developments regarding methods and related regulations.


FDA publishes Draft Guideline on Use of Nanotechnologies for Biological Medicinal Products

The FDA expands their guidelines regarding the use of nanotechnologies with a draft on the topic "Drug Products, Including Biological Products, that Contain Nanomaterials".


Alarms and Delay Times from a GMP Viewpoint

Up-to-date monitoring systems produce vast amounts of data, e.g. pressure, humidity and temperature in clean rooms. In pharmaceutical production practice, there are different approaches to handle this electronic data - alarms especially. Not all of them are ideal from a GMP viewpoint.


FDA strengthens Public Warning and Notification of Recalls

To expedite release of recall information the FDA published a draft guidance to ensure better, more timely information reaches consumers. Read more about FDA’s policy on public warning and notification of recalls.


Revised USP Chapter for Elastomeric Closures now official

End of December the USP published its revised chapter <381> Elastomeric Closures for Injections which became official on January 1, 2018.


Specifications and Acceptance Criteria for Impurities: new FDA Principles!

The FDA's Office of Pharmaceutical Quality has published a new MAPP document (Manual of Policies and Procedures) on acceptance criteria and specifications for impurities. In provides principles on the determination of specifications and acceptance criteria for non-mutagenic impurities in authorisation applications, based on clinical relevance. Read more about the Office of Pharmaceutical Quality's new FDA document.


Quality Risk Management: What Inspectors are looking for

ICH Q9 is the major guideline providing principles and examples of tools for Quality Risk Management (QRM). But how do competent authorities look at these systems in their GMP inspections?


Effect of the new Annex 13 on Complaints and Recalls

The final "Detailed Commission guidelines on GMP for IMPs for human use" have been published in Annex 13 of the EU GMP-Guidelines. What has changed in comparison to the previous Annex 13 in regard to complaints and recalls?


The new Annex 1 and 5 µm Particles

In the current EU GMP Annex 1, the monitoring of 0.5 and 5 µm particles in clean rooms is a requirement. It refers to technical document ISO 14644, Part 1 for measurement. However, the limit for 5 µm for class ISO 5 (ISO 4.8) has been removed from this document. That is why there had been great expectations for the revised Annex 1 draft.


How is the Data Governance System to be implemented in your Company?

The PIC/S draft guideline "Good Practices for Data Management and Integrity" requires every company to have a data governance system in place in addition to their existing QM system. But how can such a system be implemented? Find out more about the requirements and specifications of the PIC/S guideline for the pharmaceutical Data Governance System.


FDA Inspection leads to Import Ban

A company in Canada had sourced products from a supplier who was listed on FDA Import Alert. Therefore, the FDA declared an immediate import ban in this company, as well. Find out more about the FDA Warning Letter to Aztex Enterprises.


GDP Deficiency Data available

The British Medicines and Healthcare Products Regulatory Agency (MHRA) has published a report summarising GDP inspection deficiency data from its 2016 inspections.


Company cited by FDA for poor Transportation Practice

The US FDA published a form 483 criticising the shipping practice of a pharmaceutical company. They simply ignored temperature excursions and respective complaints.


Question & Answers on Chapter 1 QUALITY MANAGEMENT of the EU Good Distribution Practice Guideline

The European GDP Guideline which has been published in a revised version on 7 March 2013 has caused a lot of discussion since then. Many requirements leave room for interpretation. On the GDP Association Webpage a section has been set up with frequently asked questions (FAQs). Please read more about the new Questions and Answers on GDP


Changes which lead to a GMP Inspection

Manufacturing and Importation Authorisation holders must not change the terms of the authorisation without prior approval of the authority. But also other GMP related changes require notification to the national competent authority.


Warning letter due to missing GMP documentation

A functioning quality assurance unit normally guarantees a minimum level of GMP. If this entity is missing, however, basic GMP requirements are not met. Read here, which basic GMP documents FDA inspectors found missing while visiting a pharmaceutical company.


WHO publishes Guideline on Worker Safety relating to Nanomaterials

Relating to the increasing use of nanomaterials in manufacturing and the possible following risks for manufacturing staff the WHO issued a new guideline document entitled "WHO guidelines on protecting workers from potential risks of manufactured nanomaterials" .


Regulatory requirements for Audit Trail Reviews

Audit Trails and their reviews are an important requirement in the current GMP policies. Specific requirements can be found in a number of guidelines, these days. Despite that, many questions about the specific implementation of this complex topic into practice remain. Read more about the EU, PIC/S and FDA requirements concerning Audit Trails and their reviews.


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