GMP Compliance Corner — Edition 19
Quick housekeeping: for the school-holiday period we’ve moved to an every-other-Monday rhythm. The workload is a bit wild right now, and this cadence lets the team keep publishing while making each update more meaningful for you. Thanks for sticking with us stronger, tighter editions ahead.
Quick housekeeping: for the school-holiday period we’ve moved to an every-other-Monday rhythm. The workload is a bit wild right now, and this cadence lets the team keep publishing while making each update more meaningful for you. Thanks for sticking with us stronger, tighter editions ahead.
Dropping today: “What is the SMF and what should go in it?” A short, practical walkthrough of the Site Master File—why regulators care, what sections to include, and tips to keep it audit-ready. https://youtu.be/lpd_Vfczc90
Pharma news — deep dive
FDA: first immunotherapy for RRP. The FDA approved Papzimeos (zopapogene imadenovec-drba) for recurrent respiratory papillomatosis—first of its kind for this condition. Link: https://www.fda.gov/news-events/press-announcements/fda-approves-first-immunotherapy-recurrent-respiratory-papillomatosis
New FDA novel approvals logged. Updates include brensocatib (Brinsupri) for non-CF bronchiectasis and zongertinib (Hernexeos) for HER2-mutant NSCLC. Link: https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025
Pain management: Tonix win in fibromyalgia. FDA cleared Tonmya—first new fibromyalgia therapy in 15+ years; launch expected Q4. Link: https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-tonix-pharmas-drug-manage-pain-related-chronic-condition-2025-08-15/
EMA CHMP July highlights. 13 new medicines recommended (incl. lenacapavir for PrEP, olezarsen for FCS, vorasidenib for low-grade glioma); donanemab positive after re-examination; Elevidys negative opinion. Link: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-21-24-july-2025 (European Medicines Agency (EMA))
MHRA field safety notices (UK). Latest device/medicines FSNs (4–8 Aug) published—worth a quick scan for QA teams. Link: https://www.gov.uk/drug-device-alerts/field-safety-notices-4-to-8-august-2025
Deals & CRO/clinical-site activity. THL Partners to acquire Headlands Research (~$600M) as PE keeps piling into trial networks; Cardinal Health to buy Solaris Health for $1.9B. Links: https://www.reuters.com/legal/transactional/thl-partners-acquire-clinical-trial-firm-headlands-kkr-2025-08-14/ ; https://www.reuters.com/legal/transactional/cardinal-health-buy-solaris-health-19-billion-posts-weak-results-2025-08-12/
Upcoming training & conferences (next 4 weeks)
SPS QA bite-size: Change management in pharmacy aseptic services — 20 Aug 2025, 13:00–14:00 (UK), online (Webex). Details: https://www.sps.nhs.uk/articles/change-management-in-pharmacy-aseptic-services/ (SPS - Specialist Pharmacy Service)
ISPE – HVAC for Pharma Facilities (T14) — 19–21 Aug 2025, online live. Details: https://ispe.org/training (ISPE)
ISPE – GAMP®5, Annex 11/Part 11 (T45) — 1–3 Sep 2025, online live. Details: https://ispe.org/training/2025-september (ISPE)
ISPE – GMP Fundamentals (G01) — 2–5 Sep 2025, online live. Details: https://ispe.org/training/2025-september (ISPE)
ISPE – Cleaning Validation Principles (T17) — 8–11 Sep 2025, online live. Details: https://ispe.org/training/2025-september (ISPE)
ISPE – Pharmaceutical Water Generation (T04) — 9–12 Sep 2025, online live. Details: https://ispe.org/training/2025-september (ISPE)
ISPE – Critical Utilities (T65) — 15–18 Sep 2025, online live. Details: https://ispe.org/training/2025-september (ISPE)
PDA/FDA Joint Regulatory Conference 2025 — 8–10 Sep 2025, Washington, DC (workshops 11–12 Sep). Details: https://www.pda.org/global-event-calendar/event-detail/pda-regulatory-conference-2025 (Default)
PIC/S – PMDA-ATC GMP Seminar — 17–19 Sep 2025, online/HyFlex (regulator-led). Details: https://picscheme.org/en/events (PIC/S)
NHS Aseptic & SPS updates (last 1–2 weeks)
Submitting iQAAPS Quality Indicators (QIs) — updated 14 Aug 2025 Guidance for Accountable Pharmacists on submitting QIs for NHS Section 10 aseptic prep via iQAAPS. Link: https://www.sps.nhs.uk/articles/submitting-iqaaps-quality-indicators-qis/
Understanding iQAAPS — 14 Aug 2025 Overview of iQAAPS access, training resources, and support contacts. Link: https://www.sps.nhs.uk/home/guidance/aseptic-services/ (see “Understanding iQAAPS”). (SPS - Specialist Pharmacy Service)
SPS QA bite-size (Webex): Change management in pharmacy aseptic services — 20 Aug 2025, 13:00–14:00 (UK) Drop-in session focused on managing change in aseptic services. Link: https://www.sps.nhs.uk/articles/change-management-in-pharmacy-aseptic-services/
New Medicines News — July 2025 issue posted (page updated 7 Aug 2025) Monthly horizon scanning bulletin with launches and regulatory changes. Link: https://www.sps.nhs.uk/articles/new-medicines-news/
Minimising risks with injectable iron — updated ~14 Aug 2025 Mitigation strategies for hypersensitivity and skin-staining; links to product-confusion risk advice. Link: https://www.sps.nhs.uk/articles/minimising-risks-associated-with-administration-of-injectable-iron/
Audit readiness tip
Site Master File (SMF) quick win
Use this 60-minute refresh to make your SMF inspection-ready:
Scope & site ID: legal entity, licences, activities in/out of scope, site map.
Org chart: named RP/QP/HoQ/HoP and deputies with responsibilities.
Products & processes: sterile/non-sterile, cytotoxic, AT(I)MPs; high-level flows.
Facilities & utilities: rooms/grades, HVAC concepts & cascades, PW/WFI, gases.
Key equipment: isolators, EM systems, critical computerized systems (Annex 11).
QMS map: change control, deviations/CAPA, complaints/recalls, risk management.
Validation status: CSV, cleaning, sterilization, media fills, transport qualification.
EM & CCS: monitoring strategy, alert/action levels, trending, last review date.
Outsourcing & suppliers: what is outsourced, how it’s qualified/monitored.
Data integrity: governance, access controls, audit trail reviews—where described.
Since last revision: material changes (facilities/equipment/QMS), with dates.
Document control: SMF doc ID, owner, version, effective & next review dates; cross-links to SOPs.
Quick check: can a new QA colleague find evidence for each bullet in <5 minutes from links inside the SMF?
Fun pharma fact
An SMF is not a dump of SOPs. It’s a top-level map that points to controlled documents. Inspectors want clarity and currency over volume—keep it concise, cross-referenced, and dated.
Summary & what’s next
We’re moving to an every-other-Monday cadence for the holidays so each edition stays meaningful.
New video today: What is the SMF and what should go in it? https://youtu.be/lpd_Vfczc90
Deep dive news: FDA/EMA/MHRA highlights with actionable takeaways for QA/QA Ops.
Recalls: UK & US items to brief your teams on this week.
Training: SPS bite-size plus upcoming ISPE/PDA sessions.
NHS Aseptic/SPS updates: iQAAPS guidance and resources to bookmark.
Audit tip: 60-minute SMF refresh checklist.
Call to action
Share this with a colleague in QA/QC or Production.
Reply with topics you want covered next (e.g., media fill pitfalls, outsourcing oversight, GDP for ATMPs).
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See you in two Mondays!