GAMP®5, a Risk-Based Approach to Compliant GxP Computerized Systems Guidelines, is a globally accepted standard for the validation of computerised systems that has been recently revised. In the end of July 2002, a new 2nd edition has been published.
European Commission published the Implementing Regulation (EU) 2022/1107 to establish common specifications for certain class D in vitro diagnostic medical devices (IVD’s) considered to be high-risk.
U.S. Food and Drug Administration Agency (US FDA) is announcing the availability of a draft guidance for industry titled Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.
The European Medicines Agency (EMA) will be updating its Guideline on active substances to incorporate strategies for controlling and preventing nitrosamines in drug products and active pharmaceutical ingredients
The definition of whistleblowing as per the Collins English dictionary is the act of telling the authorities or the public that the organization you are working for is doing something immoral or illegal.”
As part of US FDA’s continued efforts to improve transparency and provide helpful information to regulated industry and the public, the agency is issuing two final guidances for generic drug applicants.
The U.S. Food & Drug Administration (FDA) posted an article on the ways the FDA is regulating human drugs and biologics, animal drugs, medical devices, tobacco products, food, and cosmetics (Is it Really “FDA Approved”).
The current Q3D(R2) Guideline reached Step 4 on 26th of April 2022, and included a correction of PDE’s for gold, silver and nickel, Gold and Silver monographs and an addition of limits for elemental impurities by the cutaneous and transcutaneous route.
Commission Regulation (EU) 2022/63 of 14 January 2022 amending Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the food additive titanium dioxide (the Regulation) entered into force following its publication in the Official Journal of the European Union on 18th January 2022.
US Food and Drug Administration Agency (US FDA) has announced the availability of a proposed rule National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs).
Billev Pharma East can conduct on-site supplier audits on your behalf to ensure that their manufacturing activities are being executed according to your specifications and the applicable regulations.
With the application of the EU Clinical Trials Regulation No 536/2014 (CTR) some labelling requirements for investigational medicinal products (IMP’s) have changed.
The new Annex 21 Importation of medicinal products to the EU Good Manufacturing Practice (GMP) guidelines that has been published on February 21st, 2022, will enter into force on August 21st 2022.
On 7 June 2022, EMA’s Medicines Shortages Steering Group (MSSG) adopted the list of PDF icon critical medicines for the COVID-19 public health emergency .
On 4th of May 2022, the Federal Council adopted the new Ordinance on In vitro Diagnostic Medical Devices (IvDO) and the amendment to the Ordinance on Clinical Trials with Medical Devices (CTO-MedD).
For many medicinal products, storage and transportation temperatures are a highly significant factor in maintaining the quality of medicinal products throughout the distribution network.
Theranostics are diagnostic procedures, used to select appropriate patients for the appropriate therapy, maximizing the success rate and minimizing the adverse reactions.
Transition period for the use of the In Vitro Diagnostic Regulation 2017/746 (IVDR) came to an end, hence as of 26th of May its provisions are mandatory to be followed by all in vitro diagnostic medical device sector.
Five out of seven of these Annexes now correspond to the most recent status in accordance with the new requirements of the Clinical Trial Regulations No 536/2014 (CRT).
Parallel distribution is defined as the distribution of a centrally authorised medicinal product from one Member State to another by a pharmaceutical company independent of the marketing authorisation holder.
This ATP brings changes to the labelling and classification of some existing harmonized substances and adds new harmonized substances in Part 3 of Annex VI.
The purpose of this consultation is to collect relevant information from stakeholders to help the GMP/GDP Inspectors Working Group to finalise this Question and Answers guidance on remote batch certification / confirmation by the QP on a routine basis.
The annual report is set out in line with the format and objectives of the 2021 – 2023 three-year work plan and gives among other topics a detailed update on all existing MRAs
The document describes principles and examples of tools for quality risk management and consists of 56 pages of comments from organizations such as the PDA, EFPIA and many others.
Expectations for bootstrapping to calculate the 90% confidence interval for the f2 similarity factor when comparing dissolution profiles with high variability.
The review of batch (manufacturing) records creates a story of the materials, manufacturing, and packaging involved in the production of medicinal products.
The Medical Device Coordination Group (MDCG), a group of Member States experts, endorsed a joint implementation plan on the implementation of the IVDR.
Slovenian notified body SIQ successfully passed the designation and notification procedure under the Regulation (EU) 2017/745 on Medical Devices (MDR).
Combination products became an essential tool for the delivery of medicinal products and in the last years the number of marketing authorisation for these types of devices increased significantly.
European Commission (EC) is reporting progress in implementing strategic approach to pharmaceuticals in the environment. This approach involves all phases of lifecycle of pharmaceuticals, from development, manufacture, use and disposal.
A regulation strengthening the role of the EMA in crisis preparedness and management for medicinal products and medical devices has been published in the Official Journal of the EU (Regulation (EU) 2022/123).
The agreement between Switzerland and the European Union EU) on mutual recognition in relation to conformity assessment (MRA) of medical devices that aimed to facilitate the trade ended in May 2021.
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BILLEV PHARMA EAST can deliver an export report on ERA with strategy for development of ERA, required calculations and justifications in accordance with the guidelines.
Medical device manufacturers should
be aware of obligations laid down in
Article 15 of the MDR where there is
requirement for person responsible
for regulatory compliance (PRRC)
which also checks conf…
Risk evaluations that have been required for EU medicinal products, after potentially carcinogenic nitrosamines were identified in some classes of medicines, are still ongoing.
Billev Pharma East is aware that finding a suitable QP represents a huge challenge for many pharmaceutical companies and has the expertise to help you.
There are still so many uncertainties concerning Brexit, however, the currently planned date of UK withdrawal (‘hard Brexit scenario’) is approaching at a high speed…
New versions of electronic Applications Forms for marketing authorisation applications, renewals and variations for human and veterinary medicines have been released.
