Insufficient handling of data integrity and validation of analytical methods lead to FDA warning letter

Drug manufacturer Reine Lifescience received an FDA warning letter in May 2018. During the inspection, it was particularly criticised that the company could not provide data on the validation and verification of their analytical methods. The controls of their computerised systems have not been sufficient, either. Read more about the recent FDA warning letter to Reine Lifescience.


Will UK accept EU QP Certification after a "hard" Brexit?

The UK Government has published a notice discussing the consequences for batch testing, QP certification and batch release with an interesting statement.


FDA´s final Guidance on Elemental Impurities in Drug Products

The final FDA guidance provides recommendations regarding the required documentation related to the control of elemental impurities consistent with ICH Q3D and USP General Chapters <232> and <233>. Read more about FDA´s guidance on Elemental Impurities in Drug Products, which applies to manufacturers of noncompendial and compendial drug products.


What information is included in a CEP?

The "Certificate of suitability to the Monographs of the European Pharmacopoeia" (CEP) contains information on an active pharmaceutical substance with regard to the European Pharmacopoeia. It is an important document of the authorisation application. Read more about what information is relevant for a CEP and what do CEP holders and authorisation applicants have to consider.


Warning letter due to lacking cleaning validation, stability testing and content determination

When various active substances are being manufactured in a shared system, there are specific requirements for cleaning validation. Read here how severely defects regarding cleaning validation, stability testing and content determination can affect an FDA inspection at an API facility.


Warning letter to Indian drug manufacturer due to various deficiencies

Because of the GMP deficiencies found during an inspection and the company's response, which was deemed unsatisfactory by the FDA, the agency has now issued a warning letter. The main complaints: incoming goods testing, release, equipment design and the HVAC system.


Data integrity still in the focus of FDA: new warning letter to Japanese API manufacturer

The topics data and data integrity are still in the focus in FDA inspections. Find out more about the details of a warning letter to Japanese API manufacturer Yuki Gosei Kogyo Co. Ltd.


EMA publishes list of contact details for pharmacovigilance enquiries

The EMA published information extracted from the Article 57 database (xEVMPD) in the form of an Excel document. The file contains a complete list of all medicines authorized in the EEA with marketing authorization holders' dedicated contact details for pharmacovigilance enquiries.


FDA´s Action Plan for Biosimilars

The US Food and Drig Administration (FDA) has published its Biosimilars Action Plan in July 2018.


Data Integrity: Best Practices for using eHRs in Clinical Investigations

With the final guidance on the Use of Electronic Health Record Data in Clinical Investigations the US FDA intends to assist sponsors, clinical investigators, contract research organizations (CRO´s), institutional review boards (IRBs), and other interested parties in the use of eHR data in clinical investigations.


FDA publishes final ICH E17 Guidance on multi-regional trials

The US Food and Drug Administration (FDA) published the ICH E17 guideline on General Principles for Planning and Design of Multiregional Clinical Trials.


Notably low number of warning letters issued to device manufacturers in first half of fiscal year 2018

The evaluation of the FDA warning letters regarding medical devices of the first half of fiscal year 2017 yielded a remarkable low number of warning letters. Find out, what the evaluation of the medical devices warning letters in the first half of fiscal year 2018 showed.


What makes a medical device a medical device? New FDA guideline on product classification

On twelve pages, the new FDA guideline entitled "Classification of Products as Drugs and Devices and Devices and Additional Product Classification Issues: Guidance for Industry" describes how the FDA classifies products as drug products, medical devices or others.


New WHO guideline on medical devices and IVDs

On 76 pages spread over five chapters, the WHO has published a finalised regulatory framework for medical devices, including In-vitro-Diagnostics (IVDs), with the title "WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices".


EMA: More GMP/GDP Inspections performed

Almost 2.500 GMP inspections were performed last year by EU/EEA inspectors. And still many of them in the US.


Brexit: EMA to lose 30% Staff?

The European Medicines Agency (EMA) has  published a press release and announced the next phase of its business continuity plan. According to this release the Agency will need to further scale back and suspend activities.


Warning letter due to inadequate document management and GMP non-compliant analytical software

Facilities supervised by the FDA should pay great attention to GMP-compliant processes, especially in the areas of manufacture and quality control; otherwise, they risk failing the inspection and receiving a warning letter. Find out what defects regarding document management and analytical software FDA inspectors found at the site of an active substances manufacturer.


Successful ECA, USP and EDQM Joint Conference on Glass packaging

The "Glass meets Pharma" conference on glass packaging was held in early June in Berlin. Read more about the presentations and discussions at the first USP, EDQM and ECA Joint conference.


GCP for ATMP - Stakeholder Consultation on the Draft Guideline

The European Medicines Agency had announced a guideline on GCP for ATMPs. Now, the Draft Guideline on Good Clinical Practice for Advanced Therapy Medicinal Products has been published and is open for targeted stakeholder consultation unti end of October.


The increasing Importance of Gene Therapies - FDA Statement and New Guidelines

The increasing importance of Gene Therapy becomes obvious when you take a look at the increasing focus of the competent authorities - as, for example, the current FDA's six new guidance documents on Gene Therapies show.


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