GMP Compliance Corner — Edition 20

Quick housekeeping: we’re sticking with an every-other-Monday. The team’s workload is busy right now, and this cadence lets us keep publishing while making each update more meaningful for you.

This edition’s light focus is the EU consultation on EudraLex Vol. 4 (revamped Chapter 4 on documentation, a refreshed Annex 11 on computerised systems, and a new Annex 22 on AI). If this touches your site, it’s worth read! comments close 7 Oct 2025.

Consultation page: https://health.ec.europa.eu/consultations/stakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-4-annex_en

What Went Live in the Last 2 Weeks

What is the SMF and what should go in it? A short, practical walkthrough of the Site Master File—why inspectors care, the core sections to include, and quick wins to keep it current. Watch here: https://youtu.be/lpd_Vfczc90

GMP/GDP/Regulatory news (last 14 days)

• FDA starts daily, real-time FAERS publication The agency began publishing adverse event reports every day, boosting PV transparency and signal detection. Read more: https://www.fda.gov/news-events/press-announcements/fda-begins-real-time-reporting-adverse-event-data

• Fresh FDA approvals logged Latest novel approvals page now shows donidalorsen (Dawnzera) for HAE (21 Aug) and brensocatib (Brinsupri) for NCFB (12 Aug). Tracker: https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025

• EMA: CHMP extraordinary meeting (25 Aug) CHMP held an extra session this week (agenda items typically posted via EMA in the following days). Note: https://www.ema.europa.eu/en/events/extraordinary-meeting-committee-medicinal-products-human-use-chmp-25-august-2025

• MHRA: August Safety Roundup One-stop PDF of UK letters, recalls and device field notices sent to healthcare professionals this month. Read: https://www.gov.uk/drug-device-alerts/mhra-safety-roundup-august-2025

• MHRA: latest Field Safety Notices (18–22 Aug) Weekly list of device FSNs (handy for hospital QA review meetings). Read: https://www.gov.uk/drug-device-alerts/field-safety-notices-18-to-22-august-2025

Recalls & safety alerts (last 2 weeks)

UK — MHRA (medicines)

• Class 4 Medicines Defect Notification — Ipca Laboratories (multiple products): Allopurinol, Amlodipine, Hydroxychloroquine, Levofloxacin, Gabapentin — PILs missing required safety info. Action: continue dispensing; signpost patients to missing info; updated PILs to follow. Link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-notification-ipca-laboratories-uk-limited-various-products-el-25-a-slash-42 GOV.UK

• Class 4 — Fexofenadine 120 mg (Chanelle Medical): EAN/GTIN barcode error on certain batches. Link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-notification-fexofenadine-hydrochloride-120mg-film-coated-tablets-chanelle-medical-unlimited-company-el-25-a-slash-41 GOV.UK

• Class 4 — Levetiracetam 100 mg/mL oral solution (Accord): PIL/SPC missing safety info; some batches “not yet distributed” will ship with corrected PIL later. Link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-notification-levetiracetam-accord-100mg-slash-ml-oral-solution-accord-healthcare-limited-uk-el-25-a-slash-40 GOV.UK

US — FDA (drugs & sterile solutions)

• Unichem — Cyclobenzaprine 10 mg tablets: Mislabeling (bottles labelled Cyclobenzaprine contained Meloxicam 7.5 mg). Link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/unichem-pharmaceuticals-usa-inc-issues-voluntary-nationwide-recall-cyclobenzaprine-hydrochloride U.S. Food and Drug Administration

• B. Braun — Lactated Ringer’s / 0.9% Sodium Chloride 1000 mL: Particulate matter; nationwide recall. Link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/b-braun-medical-issues-voluntary-nationwide-recall-lactated-ringers-injection-usp-1000-ml-and-09

EU — EMA (DHPC)

• Evrysdi (risdiplam) — DHPC (21 Aug 2025): Omission of mandatory labelling statement in EU product label/SmPC; communication plan in place. Link: https://www.ema.europa.eu/en/medicines/dhpc/evrysdi

NHS Aseptic & QAAPS update — lead author confirmed

• QAAPS 6th edition underway (target: summer 2026). RPS and NHS PQAC are updating the Quality Assurance of Aseptic Preparation Services standards to reflect Annex 1 changes, iQAAPS, supervision legislation, and NHS aseptic transformation. Royal Pharmaceutical Society

• Lead author: Robert (Rob) Lowe, FRPharmS — Director of Pharmaceutical QA (SPS, East of England), former chair/vice-chair of NHS PQAC, with >30 years’ experience in production/QA/regulation. He’ll edit the final edition with working groups. Royal Pharmaceutical Society

• Current materials: Part A (5th ed.) remains the live standard; handbook available in print. Royal Pharmaceutical Society

Why this matters: QAAPS underpins NHS Section 10 aseptic governance. Expect alignment with updated Annex 1 and iQAAPS; useful to plan an internal gap scan ahead of the 6th edition

NHS Aseptic & SPS updates (mid–late Aug)

• Spotlight — August 2025 (digest) Handy round-up linking recent SPS guidance (incl. aseptic/iQAAPS items). https://www.sps.nhs.uk/articles/spotlight-august-2025/ SPS - Specialist Pharmacy Service

• Submitting iQAAPS Quality Indicators (QIs) — guidance for Section 10 aseptic units (last updated 14 Aug). https://www.sps.nhs.uk/articles/submitting-iqaaps-quality-indicators-qis/ SPS - Specialist Pharmacy Service

• Understanding iQAAPS — access, training resources and support contacts (updated 14 Aug). https://www.sps.nhs.uk/articles/understanding-iqaaps/ SPS - Specialist Pharmacy Service

• Change management in pharmacy aseptic services (QA bite-size) — 20 Aug Webex session page (useful summary if you missed it). https://www.sps.nhs.uk/articles/change-management-in-pharmacy-aseptic-services/ SPS - Specialist Pharmacy Service

• Using food supplements — policy/clinical considerations (published 26 Aug; wider medicines governance but useful for QA comms). https://www.sps.nhs.uk/articles/using-food-supplements/

Why these are worth your time

• SPS QA bite-size: Supervising pharmacy aseptic services – clean rooms (10 Sep) One practical hour led by NHS specialists—ideal for HoP/HoQ, Accountable Pharmacists and new supervisors to sanity-check day-to-day oversight in Grade D–B areas. Expect pragmatic takeaways you can apply the same week.

• PDA/FDA Joint Regulatory Conference (8–10 Sep) Direct insight from FDA and global regulators on what “good” looks like in 2025. Great for QA leads, validation/CMC, and site leadership aligning programs to evolving expectations without over-engineering.

• ISPE Online Live — September block (GAMP, GMP Fundamentals, Cleaning Validation, Water, Critical Utilities, C&Q) Bite-sized, instructor-led refreshers mapped to real shop-floor decisions. Perfect for building cross-functional literacy (QA–Production–Engineering) and closing specific gaps ahead of audits.

• ISPE Hands-On Aseptic Processing & Annex 1 (23–25 Sep, Strasbourg) If you learn best by doing: glove/sleeve, aseptic behaviors, EM and contamination control drilled in a training facility. Strong value for new aseptic supervisors and EM leads.

• PIC/S – PMDA-ATC GMP Seminar (17–19 Sep) Regulator-led perspectives on inspection focus and risk-based compliance. Useful for anyone writing/defending your site’s CCS, validation strategies, or data governance approach.

Audit readiness tip, documentation & systems tune-up

Keep it light but high-impact. Grab a coffee, set a timer for 45 minutes, and do these:

• Hybrid records register: List 5 places where paper + electronic coexist (e.g., logbooks, deviations, training, labels, sampling sheets). Add owner, where the master template lives, and retention.

• Access sanity check: Open one critical system and confirm: named admins, no shared accounts, last leavers review date, and password/audit-trail on. Screenshot and file as evidence.

• Template control: Pick two high-use forms. Ensure the master template is accessible via a controlled link; printed versions show doc ID + version; bin any old desk copies.

• Audit trail spot-check: In one system, export the last 30 days of audit trail for one record type; verify time sync, user attribution, and reason for change captured. Save in a “DQ/DI spot-checks” folder..

Pro tip: Add a one-page “Documents & Systems Map” to your SMF that points to the registers above. Inspectors love a map more than a maze.

Fun pharma fact

“First air” isn’t a place it’s a path. In aseptic processing, first air is the clean, HEPA-filtered air stream before it hits any surface. If a hand, tool, or vial blocks that path, it’s no longer first air so tiny placement tweaks of hands and kit can make a big difference to your EM trends.

Summary — Edition 20

• We’re running an every-other-Monday cadence through the school holidays so each issue stays meaningful.

• Light focus: the EU consultation on EudraLex Vol. 4 (revamped Chapter 4, refreshed Annex 11, new Annex 22 on AI). Comments close 7 Oct 2025.

• What went live: short explainer video “What is the SMF and what should go in it?” (deep-dive video on the EU docs coming soon).

• Recalls & safety alerts: UK MHRA Class 2/4 items and selected FDA/EMA actions highlighted for QA review.

• NHS Aseptic & QAAPS: iQAAPS resources flagged; Rob Lowe confirmed as lead author for the next QAAPS update.

• Training & conferences (next 4 weeks): SPS QA bite-size, PDA/FDA Regulatory Conference, and ISPE Online Live courses (GAMP, GMP, Cleaning Validation, Water, Critical Utilities, C&Q), plus PIC/S seminar.

• Audit readiness tip: a 45-minute documentation & systems tune-up—hybrid records, access/e-sig, template control, audit trail spot-check, and SaaS supplier notes.

• Fun fact: First air is a path, not a spot—keep hands/tools out of the HEPA stream.

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Kyle Winn WinnPharma

Adam Walker @PharmaQP