New suggestions by the USP on chapter <659> have been published in the Pharmacopeial Forum (PF) 44 (4). It addresses plastic packaging as well as the regulations and requirements for child-resistant packaging. Read more about chapter <659> - Packaging and Storage Requirements in this article.
After five years and thorough revision, the FDA Guidance "Bioanalytical Method Validation" has been finalised. Read here what requirements the FDA lays down for a completely validated bioanalytical procedure.
ICH Q12, currently in draft form for public consultation, provides an opportunity to save time and money associated with regulatory submissions. Read more about "new" lifecycle tools and enablers for global post-approval change management provided in the proposed guideline on "Life Cycle Management".
Published in its 21st edition by now, the GMP Matrix has been a recognised standard for GMP auditors or QA units since 2005, and not only in multinational companies. The Matrix juxtaposes the US cGMP requirements as per CFR 210/211 with the EU GMP Guidelines. What has changed in recent years in particular?
The FDA published two new draft guidelines on Risk Evaluation and Mitigation Strategy (REMS) for sponsors of clinical trials. Read more about the draft documents on developing a shared system REMS, and waivers associated with the single, shared system REMS requirement.
The EDQM has announced the suppression of the Highly Purified Water (HPW) Monograph (1927) in 2019. This was justified with the revision of the European Pharmacopoeia which now allows non-distillation methods for the production of water for injection (WFI). As a consequence, the monograph became redundant.
The FDA published a draft guidance on Data Integrity in clinical studies of veterinary medicinal products to support new animal drug applications. Read more about the documentation of Electronic Data Files and Statistical Analysis Programs.
On 22 June, it became official: the International Council for Harmonisation (ICH) announced in a press release that with the new Guideline ICH Q13, they would support the introduction of continuous manufacturing processes into the pharmaceutical industry.
Chinese manufacturer of active pharmaceutical ingredients Jilin Shulan Synthetic Pharmaceutical received an FDA warning letter in May 2018. It was criticised in particular that the Company did not record, investigate and solve laboratory OOS results. It was also criticised that the Audit Trails of the electronic laboratory instruments (HPLC, GC, IR) were not enabled. Find out more about the Jilin Shulan Synthetic Pharmaceutical Warning Letter.
In a press release from 22 June 2018 the International Council for Harmonisation (ICH) has announced that they will prepare new topics for the future that are of great importance for the pharmaceutical industry. The Council intends to begin developing the ICH Guidelines Analytical Procedure Development and Revision of Q2(R1) Analytical Validation (Q2(R2)/Q14)" and "Continuous Manufacturing (Q13)". Find out more about this important ICH Press Release.