How to Export Medical Cannabis Internationally
Over the past few years, our international trade team has advised a rapidly expanding suite of clients on import/export issues related to cannabis
Biosimilar Pharmaceuticals in Canada: Fact Sheet
Author: Bhavesh Patel, Natco Pharma (Canada) Inc. This past August, Health Canada published a document titled “Biosimilar Biologic Drugs in Canada: Fact Sheet” to provide a comprehensive overview on a number of issues concerning biosimilar biologic drugs (also referred to as “subsequent entry biologics”). A biosimilar biologic drug, or biosimilar, is a biologic drug that […]
PIC/S has announced a focused stakeholders consultation on revised draft PIC/S GMP Guide Annex 2A (Manufacture of Advanced Therapy Medicinal Products for Human Use) and Annex 2B (Manufacture of Biological Medicinal Substances and Products for Human Use)
Geneva, 20 September 2019 This revision is subject to a focused stakeholder consultation which includes both consultation questions and an opportunity to comment on: – a draft Annex 2A (PS/INF 25/2019 (Rev. 1)): Manufacture of Advanced Therapy Medicinal Products for Human Use; and – a draft Annex 2B (PS/INF 26/2019 (Rev. 1)): Manufacture of […]
GMP Requirements in the EU
The contents of this article will discuss GxP, Good Manufacturing Practice, Good Distribution Practice and Market Authorisation Holder compliance overview. EU requirements differ from those anywhere else in the world.
The importance of GxP Compliance for Global Cannabis Production
The debate surrounding global cannabis legislation has been ongoing for many years due to its potential side effects versus the claimed antioxidant, anti-inflammatory and neuroprotective benefits. Cannabinoids are substances found in the cannabis plant.
The Role of the QP in Europe: Why do you need a QP?
According to European regulations, no batch of medicinal product can be released for sale or supply prior to certification by a Qualified Person (QP)
FDA Inspection Readiness – is your company ready?
All Pharmaceutical Quality Systems must operate to a high standard on a daily basis without the requirement for any major preparation activities in advance of an inspection if they are to be considered inspection ready.
Top Tips – Building your ISO Quality Management System
A Quality Management System (QMS) is key for pharma companies and should encourage organisations to comply with ICH Q10 and ISO guidance.
Lessons Learned: Change Control Post- Implementation – Ensuring Documentation and Workflow Align to Compliance Requirements
Regulatory agencies such as the FDA stress the importance of periodically holding lessons learned discussions to review compliance in change control.
Brexit Checklist for the Pharma Industry
A disorderly Brexit is moving from a possibility to a probability. While governments pass last minute legislation over the month of March, it is encouraging to be part of a responsible industry that treats the threat to patients very seriously and has, according to our government officials, prepared very well for the changes ahead.