Pharma & Life Sciences

PIC/S EU GMP Guides: Consultation on Documentation, AI, and Computerised Systems

PIC/S and the European Commission have launched a joint stakeholder consultation on revisions to the EU GMP Guides, specifically Chapter 4 (Documentation) and Annex 11 (Computerised Systems), and a new Annex 22 on Artificial Intelligence. The consultation period runs from July 7, 2025, to October 7, 2025.

PIC/S GMP Annex Revisions and Membership Applications

The EMA and PIC/S have released concept papers for revisions to GMP Annex 15 (Qualification and validation) and Annex 6 (Manufacture of medicinal gases). These documents are open for public consultation until April 2026. Additionally, Kazakhstan has applied for PIC/S membership.

PIC/S GMP Guide Revisions and Membership Updates

The EMA and PIC/S have released concept papers for public consultation on revisions to EU-PIC/S GMP Annex 6 (Manufacture of medicinal gases) and Annex 15 (Qualification and validation). These revisions aim to update guidelines to reflect current industry practices, new technologies, and ICH Q9(R1). Kazakhstan has also applied for PIC/S membership.

Field Safety Notices Issued March 2-6, 2026

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a list of Field Safety Notices (FSNs) issued between March 2 and March 6, 2026. These notices detail safety concerns and required actions for specific medical devices, including those from ArjoHuntleigh, BD, Cook, Löwenstein, and OXOID.

Class 2 Medicines Recall: Curaleaf Oil

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 Medicines Recall for three batches of Curaleaf Oil due to low THC content. Healthcare professionals are instructed to stop supplying the affected batches immediately.

Class 3 Medicines Recall: Bayer Plc, Various Products

Bayer Plc is recalling specific batches of Gastrografin, Urografin 150 Solution, and Urografin 150 Injection due to an impurity exceeding acceptable limits. This recall is a precautionary measure at the pharmacy and wholesaler level.

Ford Truck Recall - Backup Alarm May Not Sound

Transport Canada has issued a recall (2026096) for certain Ford trucks where a loose electrical connector may prevent the backup alarm from sounding. This poses a safety risk to road users. Ford will notify owners to have the connector replaced at a dealership.

Airstream RV Trailers Recalled Due to Electrical Fire Risk

Transport Canada has issued a recall for certain Airstream RV trailers due to a risk of electrical fire caused by potentially cracked wire connections in the SmartPlug 30 A shore power inlet. Owners are advised to take their trailers to a dealership for inspection and potential replacement of the power inlet.

Ford and Lincoln SUV Recall - Faulty EGR Valve

Transport Canada has issued a recall for certain 2025 Ford Explorer, Ranger, Bronco, Mustang, Maverick, Escape, Bronco Sport, and Lincoln Corsair and Nautilus vehicles due to a potentially faulty EGR valve. The defect could lead to a sudden loss of power, increasing the risk of a crash.

Transport Canada Recall: Ford SUV Seats

Transport Canada has issued a recall for certain Ford SUVs due to a potential issue with the driver's seat that could cause a loss of control. Ford will notify owners and provide a software update to correct the defect.