In March 2015, the British authority MHRA has summarised and interpreted the existing GMP requirements for data security in a new guideline ("MHRA GMP Data Integrity Definitions and Guidance for Industry"). These requirements apply to all electronically stored data - regardless of the technology used for data saved in MS Excel. Learn more about the relevance of the MHRA Guideline for MS Excel.
Two new USP General Chapters on extractables and leachables have become official on August 1, 2015 (USP 38-NF33, first supplement): <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems and <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems. References to these new chapters have now been integrated in the drafts of General Chapters on Ophthalmic Products <771> and Injections <1> (PF 41(5)).
The international Conference on Harmonisation (ICH) changes its name to The International Council for Harmonisation (ICH) and reforms its organisational structure. Read more about ICH´s organisational changes.
The "new" FDA Process Validation Guideline has been in force since January 2011. The revised Annex 15 has been valid since 1 October 2015. At a Conference in September 2015, which was co-sponsored by the FDA, Grace McNally, Senior FDA Official, reported about similarities and differences between the two documents from the perspective of the FDA.
Sometimes a clear definition of terms is crucial in the communication between authorities and pharmaceutical companies. Find out what the European Medicines Agency EMA defines as "complex manufacturing steps" and what authorisation holders providing a variation application need to consider.
Pharmeuropa 27.4 comprises a draft of Ph. Eur. Chapter 5.15. "Functionality-Related Characteristics of Excipients" - covering the critical quality attributes (CQAs) of excipients. Find out more about the Ph. Eur. Chapter 5.15 draft.
How and to what extent do pharmaceutical companies need to document the origin of pharmaceutical starting materials? Read here, what the EMA expects with regard to the verification of the supply chain for APIs and starting materials.
As a consequence of implementation of the Clinical Trial Regulation 536/2014 four new public consultations concerning good manufacturing practices and clinical trials for human medicinal products were opened August 28, 2015. It is expected that Annex 13 will be deleted from EudraLex Vol 4 when the new guidelines "Detailed Commission guidelines on GMP for IMPs for human use" become operational. Find out more about the current changes in EU regulations regarding IMPs.
The WHO published a revised working document of the guideline which specifically addresses the requirements for HVAC systems used during the manufacture of non-sterile pharmaceutical dosage forms for public consultation in September.
The revised USP General Chapter <661> (Containers - Plastics) and new General Chapters <661.1> and <661.2> will become official on May 1, 2016 (USP 39-NF34). Find out more about the USP General Chapters.
The EDQM has released a report with the goal to provide further insights into developments in the blood transfusion chain in Europe. Read more about these "Trends and observations on the collection, testing and use of blood and blood components in Europe."
Related to the increasing complexity of Human Leucocyte Antigen Testing methodolgy in the field of transfusion and transplantation, the FDA published a guidance document "Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation".
Related to GMP non-compliance of a collagen sponge excipient, the European Medicines Agency (EMA) started a review of InductOs, an implant kit for bone development. Read more about the European Medicines Agency's press release.
With the publication of the new GDP Guideline in the year 2013 the legal requirements concerning the Good Distribution Practice have increased significantly. Therefore, more and more companies look for opportunities to get a GDP certificate. But this often leads to unnecessary costs. Read more in our news on GDP certificates.
The occurrence of foreign particles in the manufacture of active pharmaceutical ingredients is always undesirable. For the responsible QA departments it involves an increased effort as concerns the search for the root causes and for CAPA measures. A new APIC Guidance offers concrete recommendations for the GMP compliant handling of foreign particles in APIs, intermediates and raw materials.
The Warning Letters the FDA sent to active ingredient manufacturers last fiscal year, show similar patterns. Find out more about the frequent deficiencies found in the area of responsibility of quality assurance and in the handling of electronic data in production facilities for active pharmaceutical ingredients.
In March 2015 the Slovenian GMP Inspectors have conducted a GMP Inspection at the company Polydrug Laboratories PYT. LTD. in Maharashtra, India. Now it seems that both Health Canada and the US FDA have used the GMP inspection report of the Slovenian Authority to decide on consequences for supplies to Canada and the US. Read more about the compliance actions taken against Polydrug.
The guideline ICH Q3C on residual solvents is one of the most frequently revised ICH documents as a result of new scientific findings. The draft ICH Q3C(R6) was recently published. Find out here what manufacturers of active pharmaceutical ingredients and excipients must observe with regard to toxicity and solvents.