GMP Compliance Corner — Edition 22
Focus: The 5 Ps of GMP People | Premises | Processes | Products | Procedures — the backbone of every robust GMP system. Our latest video walks through practical, shop-floor application. Watch: https://youtu.be/meuk8fxw-zc
Help Me GMP
10/6/20254 min read
GMP Compliance Corner — Edition 22
Focus: The 5 Ps of GMP
People | Premises | Processes | Products | Procedures — the backbone of every robust GMP system. Our latest video walks through practical, shop-floor application. Watch: https://youtu.be/meuk8fxw-zc
What Went Live Recently
The 5 Ps of GMP — Everything You Need to Know A clear baseline you can reuse for inductions and refreshers. Watch: https://youtu.be/meuk8fxw-zc
Who is the RP and What do they do? A clear and easy to understand video about the roll of the Responsible Person. Watch: https://youtu.be/JYum6MzLHA4
GMP / Regulatory News
EU Consultation: Chapter 4, Annex 11 and New Annex 22 (Artificial Intelligence)
Opened: July 2025 by the European Commission and EMA GMDP Inspectors Working Group.
Closes: 7 October 2025 (23:59 CEST)
What’s proposed:
Why it matters: the most significant structural update to EU GMP since 2011. Even post-Brexit, UK sites exporting to the EU must comply.
Submit comments: https://health.ec.europa.eu/consultations/stakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-4-annex_en
FDA Expands Use of Unannounced Foreign Inspections
Announced: 6 May 2025 (official FDA press release).
Scope: expansion of pilot unannounced inspections in India and China to all foreign manufacturers of medicines, APIs, and medical products for the U.S. market.
Objective: parity of oversight with U.S. domestic sites and faster detection of falsified data or temporary compliance “clean-ups.”
Implication: overseas CMOs supplying NHS or UK distributors under U.S. contracts will face surprise audits; MHRA inspectors are expected to mirror this risk-based trend.
FDA Final Guidance – Computer Software Assurance (CSA)
Published: 24 September 2025 (FDA CDRH final guidance).
Core principle: validation effort must be risk-based—software directly impacting product quality or patient safety needs formal scripted testing; lower-risk tools may rely on unscripted or vendor assurance evidence.
Applies to: production, quality, and laboratory systems (LIMS, MES, eQMS, utilities monitoring).
Expected by inspectors: documented risk classification, defined assurance approach, and traceable testing evidence.
FDA QMSR – Alignment of 21 CFR 820 with ISO 13485
Final rule: issued 2 February 2024; enforcement date 2 February 2026.
Key facts: the Quality Management System Regulation (QMSR) replaces the current QSR to harmonise U.S. device GMPs with ISO 13485:2016.
What’s changing:
Action for combination-product or device-handling sites: start a documented QMSR gap analysis in 2025 to evidence readiness before 2026.
FDA PreCheck & On-shoring Manufacturing Meeting
Public meeting: 30 September 2025 (“Onshoring Manufacturing of Drugs and Biological Products”).
Purpose: to launch FDA PreCheck — a voluntary early-engagement program to accelerate review and inspection readiness for U.S. drug-manufacturing sites.
Impact: may shorten approval timelines for U.S.-based facilities and influence global supply-chain planning for dual-supply products.
Reference: FDA Federal Register notice and meeting page (Sept 2025).
MHRA Safety Round-up – August 2025
Issued: 29 August 2025 on GOV.UK.
Contained: Class 2 recall (Fucidin 250 mg Tablets, impurity exceedance) and Class 4 defects (Fexofenadine barcode, Levetiracetam PIL, Topiramate PIL, Ipca multi-product leaflets).
Use: ideal agenda item for monthly QA review meetings to confirm pharmacy notifications are current.
Read: https://www.gov.uk/drug-device-alerts/mhra-safety-roundup-august-2025
MHRA Consultation – Health Institution Exemption (HIE) for Medical Devices
Status: Open (Aug – 15 Oct 2025).
Aim: collect stakeholder feedback on how in-house manufactured or modified medical devices are governed under the HIE.
Why engage: this consultation will influence how NHS units and hospital engineering departments demonstrate device traceability and QMS compliance.
Submit: https://www.gov.uk/government/consultations/health-institution-exemption-hie-survey
MHRA Inspectorate Update – GMP Certificate Validity
Posted: 23 September 2025 on the MHRA Inspectorate Blog.
Clarification: GMP/GDP certificates shown in EudraGMDP do not “expire” on their listed dates; they remain valid until superseded or withdrawn following inspection.
Action: QA teams should update internal supplier-approval SOPs accordingly.
Decentralised and Point-of-Care Manufacturing Regulations 2025
Came into force: 23 July 2025 (GOV.UK Statutory Instrument).
Creates: a hub-and-spoke model for decentralised manufacture of medicines within the UK.
Highlights: the hub retains the MIA licence and QP oversight; spokes operate under the hub’s QMS and Annex 1 standards.
Relevance: critical for NHS aseptic and cell-therapy services planning local manufacture.
Recalls & Safety Alerts
UK — MHRA (medicines)
Fexofenadine 120 mg (Chanelle Medical) — Class 4 (barcode error) Carton EAN/GTIN scans to the wrong product (Naratriptan). Medicine content is correct; quality not affected. Continue dispensing; pharmacy systems will flag the mismatch. GOV.UK
Ipca Laboratories — multiple products (Allopurinol, Amlodipine, Hydroxychloroquine, Levofloxacin, Gabapentin) — Class 4 (PILs missing info) Keep supplying; signpost patients to the MHRA notice until corrected PILs arrive (from Nov 2025 for new packs). GOV.UK
Levetiracetam 100 mg/mL oral solution (Accord) — Class 4 (PIL/SPC omissions) Continue supply; updated leaflets to follow with future shipments. GOV.UK
US — FDA (drugs & sterile solutions)
B. Braun — 1000 mL Lactated Ringer’s & 0.9% Sodium Chloride — recall to hospital level (particulates) Action: stop use, quarantine affected lots, return to manufacturer. No serious injuries reported to date. U.S. Food and Drug Administration
Unichem — Cyclobenzaprine 10 mg mislabeled bottles actually contained Meloxicam 7.5 mg — consumer-level recall Risk: inadvertent NSAID exposure (e.g., allergy, GI risk). Action: pharmacies to contact patients and arrange returns. U.S. Food and Drug Administration
EU — EMA (DHPC)
Evrysdi (risdiplam) — omission of mandatory labelling statement Updated SmPC/label to be implemented; verify pack info during dispensing. European Medicines Agency (EMA)
NHS Aseptic & QAAPS Update
Work on the 6th Edition of QAAPS is underway under RPS leadership; scope points include supervision, Annex 1 alignment, and digital/AI governance. Adam and Kyle are contributing to the author team. Programme info here. Public Health
Training & Events
QPQuandary Ltd — RSC-approved QP Masterclasses (all 13 modules now formally approved) Recognition announced by QPQuandary; check RSC listings for approved modules and CPD options. Useful for aspiring and current QPs. Tanya Agombar
PDA/FDA Joint Regulatory Conference (8–10 Sep) — regulator perspectives on inspection expectations and quality culture.
ISPE short courses (GAMP, Cleaning Validation, Water & Utilities, C&Q) — practical refreshers mapped to shop-floor decisions.
Audit Readiness Tip: “5 Ps”
People: competence evidence beyond attendance; leavers’ access removed in LIMS/MES/QMS.
Premises: EM trends — excursions and recoveries have root cause and effectiveness checks.
Processes: Stage-3 CPV truly live; deviations trended to prevention.
Products: supplier status current; batch traceability from raw to release verified.
Procedures: live practice matches SOP; obsolete printouts removed.
Fun Pharma Fact
“GMP” entered U.S. regulation in the early 1960s, but its spirit goes back to the 1906 Pure Food and Drug Act, which outlawed misbranded/adulterated medicines — the original quality baseline.