GMP Compliance Corner — Edition 21

Big news this edition: both Adam Walker and Kyle Winn have been selected to help re-write the QAAPS standards with the Royal Pharmaceutical Society. This is a huge honour and a real chance to shape the future of Section 10 aseptic services across the NHS. We’re proud to play a part in strengthening the governance of aseptic production, aligning practice with Annex 1, iQAAPS, and the wider transformation agenda.

RPS QAAPS programme page: https://www.rpharms.com/recognition/setting-professional-standards/quality-assurance-of-aseptic-preparation-services

And another milestone to celebrate: The Help Me GMP channel has now passed 1,000 subscribers on YouTube! A big thank you to everyone who’s been supporting, sharing, and learning with us.

What Went Live in the Last 2 Weeks

What Does a Responsible Person Really Do? A clear, practical walkthrough of the RP role — why it matters for GDP, what the responsibilities actually cover, and how it supports supply chain integrity. Watch here: https://youtu.be/JYum6MzLHA4

Annex 22 Changes You Need to Know! Deep-dive explainer on the draft Annex 22 (AI in GMP) consultation. What it proposes, why it matters, and how sites should start preparing. Watch here: https://youtu.be/Tgrs6G_N_ZU

GMP/GDP/Regulatory news (last 14 days)

FDA launches risk-based inspection dashboard New tool visualising inspection priorities and inspection outcomes across manufacturing sites. Read more: https://www.fda.gov/inspections

EMA publishes Q3 signals report Latest EU pharmacovigilance signal assessments are now available. Read: https://www.ema.europa.eu/en/documents/psusa

MHRA device safety notices (2–13 Sep) Latest batch of FSNs — useful to review at QA governance meetings. Read: https://www.gov.uk/drug-device-alerts

Recalls & safety alerts (last 2 weeks)

UK — MHRA (medicines)

• Class 2 — Labetalol 100 mg (Mylan): Mislabelled strength on cartons. Quarantine affected stock. Link: https://www.gov.uk/drug-device-alerts

• Class 4 — Simvastatin 20 mg (Teva): PIL error — missing contraindication warning. Link: https://www.gov.uk/drug-device-alerts

US — FDA (drugs & sterile solutions)

• Pfizer — Lidocaine injection: Particulate matter detected, recall initiated. Link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

• Hospira — Sodium Bicarbonate 8.4% injection: Cracked vials risk sterility breach. Link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

EU — EMA (DHPC)

• Zejula (niraparib): DHPC issued for risk of severe anaemia; monitoring requirements updated. Link: https://www.ema.europa.eu/en/medicines/dhpc

NHS Aseptic & QAAPS update

QAAPS 6th edition — authorship milestone Adam and Kyle have been confirmed as contributors to the new QAAPS standard alongside the Royal Pharmaceutical Society and SPS QA leadership. Drafting is under way with working groups expected to run into 2026.

Why this matters: QAAPS is the foundation of NHS Section 10 aseptic governance. With Annex 1 and iQAAPS already reshaping expectations, the next edition will be critical for assuring safe, consistent practice. Sites should start early gap analyses against current QAAPS Part A to prepare for transition.

RPS QAAPS programme: https://www.rpharms.com/recognition/setting-professional-standards/quality-assurance-of-aseptic-preparation-services

SPS updates

• September Spotlight digest: Collated SPS guidance and QA resources. https://www.sps.nhs.uk/articles/spotlight-september-2025/

• iQAAPS submission support: Refreshed guidance for uploading QIs. https://www.sps.nhs.uk/articles/submitting-iqaaps-quality-indicators-qis/

Training worth your time

• SPS QA bite-size: supervising aseptic services — Grade B/C areas (24 Sep) One-hour practical refresher for supervisors and Accountable Pharmacists.

• ISPE Pharma 4.0 & Annex 11 (30 Sep – 2 Oct, Vienna) Timely look at digitisation, data integrity, and system validation.

• PDA Europe conference on visual inspection (7–8 Oct, Berlin) Focus on particles, container closure, and Annex 1 alignment.

• FDA/PIC/S global webinar (9 Oct) Regulator-led perspectives on cross-border inspection findings.

Audit readiness tip — QAAPS alignment pre-check

With QAAPS drafting now under way, this is a good time to sanity-check your site’s current position:

1. Supervision policy: Review your supervision SOP against Annex 1 para 2.2.

2. Competence framework: Map technician training records against iQAAPS indicators — highlight gaps.

3. Batch documentation: Cross-check against QAAPS Part A section 9 — especially deviations/overlabelling.

4. Physical environment: Walk cleanroom corridors. Do flows, door controls, and EM align with your CCS?

Pro tip: Create a “QAAPS 6th Edition Readiness” folder and drop these checks in. It’s quick evidence for PQAC reviews.

Fun pharma fact

The word “pharmacy” comes from the Greek pharmakon, meaning both “remedy” and “poison.” A reminder that dose, purity, and quality have always drawn the line between therapy and harm.

Summary — Edition 21

• Every-other-Monday cadence continues.

• Headline: Adam and Kyle join RPS-led author team for QAAPS 6th edition — a major honour for Section 10 aseptic services.

• Milestone: Help Me GMP channel has now passed 1,000 subscribers.

• What went live: RP role explainer + Annex 22 consultation deep dive.

• Regulatory news: FDA inspection dashboard, EMA signals, MHRA FSNs.

• Recalls: UK Class 2/4, FDA injectables, EMA DHPC.

• NHS/SPS: QAAPS authorship confirmed; new iQAAPS resources.

• Training: SPS, ISPE, PDA, FDA/PIC/S events late Sep/early Oct.

• Audit readiness: QAAPS pre-check folder.

• Fun fact: “Pharmacy” = remedy and poison.

Kyle Winn WinnPharma

Adam Walker @PharmaQP