Get consulting from Sterling
Expert and experienced consultants, 8,100+ client engagements in 60+ countries, from gap assessment to a system ready for its certification audit.
Talk to a Sterling consultant← All courses
Awareness training · Good practice (GxP)
Annual GMP Refresher Training: 2026 Edition
Part of the Pharmaceutical GMP learning path → Step 1
GMP refresher training is due again, and you need something better than last year's slides: a refresher that tells your people what actually changed this year, what inspectors found, and why the basics still matter. If you are the training coordinator, QA lead or supervisor who has to get a whole site through its annual GMP training, this training course was built for you.
The 2026 edition opens with the year's changes to the US and EU GMP texts, recent FDA warning letters, an EU statement of non-compliance and Class I recalls. It then refreshes the essentials every employee keeps current, from hygiene and documentation to deviations, complaints and inspections, with US and EU references given in one line. Your staff finish knowing what is new, and your training records show a current, dated annual refresher.
GMP refresher training is the continuing good manufacturing practice training that US and EU rules expect staff in medicine manufacturing to receive after their initial training. An annual refresher updates employees on changes to the rules, recent inspection findings and recalls, and revisits the essentials of hygiene, documentation, data integrity, deviations and complaints.
Training a team? Get a quote for your organisation
Part of: Pharmaceutical GMP and GDP Training
Part of: GMP & Medical Devices
Secure payment by Stripe · for yourself or for your team
What you get
- 11 video modules
About 107 minutes, with captions. Watch at your own pace on any device.
- Practice after every module
Short questions check your understanding before you move on.
- Final exam
Multiple choice, with immediate retakes if you need them.
- Built by experts
Industry experts, domain specialist trainers and globally renowned auditors with 30+ years in ISO and GRC.
A certificate you can prove, and share
Verifiable certificate with a QR code anyone can scan, plus a digital badge to add to your LinkedIn profile.
See how verification works →Standard and editionGood manufacturing practice: 21 CFR Parts 210 and 211; EudraLex Volume 4
Last updated31 October 2026
Why this year's GMP refresher matters: findings from 2026
The reason to refresh GMP every year is that people forget, habits drift, and the rules and inspection focus keep moving. The 2026 cases in this course show how quickly a small lapse becomes a serious finding.
In August 2026 a US firm started a Class I recall of morphine prefilled syringes after a syringe labelled as morphine 2 mg/1 mL was found to contain hydromorphone. Between May and August 2026, FDA warning letters to manufacturers in Mexico, South Korea and India described microbiology samples recorded as taken and incubated that were never collected, and plates discarded before they could be investigated. In April 2026 an EU authority found that deviations on a sterile production floor in India went unaddressed until inspectors pointed them out.
Each of these involved trained staff. The refresher is how you keep that training alive.
Who needs annual GMP refresher training
The course is for everyone who works in or supports a GMP area, and it includes a line in each relevant module for laboratory, warehouse and engineering staff so nobody feels the course is about someone else. It suits you if:
- Your site's annual GMP training is due and you need a current, ready-made programme
- You work in production, packaging, warehouse, QC, QA, engineering or maintenance
- You supervise a team and must show that its GMP training is up to date
- An inspection or customer audit is coming and you want staff refreshed on recent findings
- Your last audit raised training effectiveness or repeated basic errors
What you will learn in the 2026 edition
The refresher is designed so that staff leave with this year's changes clear and the essentials sharpened, not repeated by rote.
- Explain why GMP training continues every year and what is new this year
- Recognise recent inspection findings and apply their lessons to your work
- Refresh the essentials of hygiene, documentation and data integrity
- Prevent contamination, mix-ups and errors in production, packaging and the laboratory
- Handle deviations, changes, complaints and recalls correctly
- Play your part in self-inspections and regulatory inspections
Course outline: 11 modules
Module 1, Why we refresh GMP every year: a recall from this year, why training continues, what is in the 2026 edition and how the course works.
Module 2, This year in GMP, what changed: final texts and drafts, including the revised Annex 19, three EU drafts, the Singapore listing, veterinary GMP and FDA foreign inspections.
Module 3, This year in GMP, findings and recalls: three 2026 warning letters, an EU finding, four Class I recalls and how to learn from them.
Module 4, The quality system and people: your role in the quality system, training and its effect, hygiene, gowning and health.
Module 5, Documents and data: this year's record findings, good documentation practice, controlled forms, logins, audit trails and backups.
Module 6, Premises, equipment and cleaning: two 2026 recalls, equipment checks, leaks, cleaning, cross-contamination and maintenance.
Module 7, Materials, production and packaging: three Class I mix-ups, receiving and testing, production checks, packaging and reconciliation.
Module 8, The laboratory and OOS results: an OOS explained away, the two investigation phases, complete records and microbiology habits.
Module 9, Deviations, CAPA and change control: reporting, the first minutes, root cause and CAPA, and planned changes.
Module 10, Complaints, defects and recalls: a 2026 recall, complaints, quality defect investigations and recall classes.
Module 11, Inspections and your GMP commitment: self-inspection, regulatory inspections including unannounced ones, talking to inspectors and the exam.
What changed in GMP rules and guidance this year
Staff do not need every legal detail, but they do need to know what is final, what is only a draft, and what it means for their work. The course draws that line clearly.
In the EU, the revised Annex 19 on reference and retention samples was adopted in June 2026 and applies from 24 September 2026. Drafts of a revised Chapter 4 on documentation, a revised Annex 11 on computerised systems and a new Annex 22 on artificial intelligence went to consultation from July to October 2025; the course names them as drafts and teaches nothing from them as a requirement. EU GMP rules for veterinary medicines and their active substances have applied since July 2026.
In the US, 21 CFR Parts 210 and 211 remain the core rules, and a separate Part 213 for medical gases took effect in December 2025. FDA announced in May 2025 that it would expand unannounced inspections at foreign sites. Underneath all of this, the expectation of continuing training is unchanged: 21 CFR 211.25 and Chapter 2 of the EU GMP Guide both require it.
How the GMP refresher training course works
You can fit this training course around shifts and deadlines. It runs online as 11 on-demand video modules, about 2 hours of video in total, on a laptop, tablet or phone, and it remembers where you stopped. Each module ends with practice questions that show straight away whether the point has landed.
The course closes with a scenario-based multiple-choice final exam drawn from the course question bank. Complete the course and its assessed final exam (pass mark 70%, one retake included) and you receive a Sterling Academy Certificate of Completion in your name, ready to file with your training records. Each module includes one event at JKL Pharma, a built example with a tablet site in Mumbai and a sterile injectables site in Singapore, which runs its own 2026 refresher alongside you.
- 11 on-demand video modules, about 2 hours of video
- Practice questions at the end of every module
- Scenario-based multiple-choice final exam, one retake included
- Certificate of Completion in your name
- Online, at your own pace, on any device
What your staff can do after the refresher
Staff return to work with this year's lessons turned into habits they can apply on the next shift.
- Tell a final rule from a draft and know which one applies to their work
- Spot the record and data practices that led to this year's warning letters
- Report a deviation at once and contain it before anyone fixes it quietly
- Prevent the label mix-ups and cross-contamination behind this year's Class I recalls
- Handle a complaint correctly and know their part in a recall
- Answer an inspector, including during an unannounced inspection, calmly and accurately
Annual GMP refresher training for your whole site
Most organisations run the refresher for everyone at once, often before a planned inspection. A company plan lets you roll this course out to every department and shift, with a dated 2026 edition that shows exactly what your staff were refreshed on.
A client administrator adds people, assigns courses and follows progress through reports, so when an inspector or customer auditor asks who has been trained on what, the answer is ready. The organisation receives one invoice for the whole plan. Get a quote for your organisation and we will size the plan to your team.
Why learn with Sterling Academy
Sterling Academy courses are built by industry experts, domain specialist trainers and globally renowned auditors with 30+ years of experience in ISO and GRC.
Sterling Academy is the training arm of Sterling International Consulting, with 8,100+ client engagements in 60+ countries over 20+ years. Every course teaches the current edition of its standard or guidance: this course is rewritten each year, and the 2026 edition was checked against the eCFR and the EudraLex Volume 4 page in October 2026.
Preview this course
Experience the learning
before you enrol.
Watch a sample from Annual GMP Refresher Training before you enrol.
Annual GMP Refresher TrainingSample
Inside the course
A clear path through the essentials.
11 modules, 11 practice checkpoints and a final exam. Video runtimes are approximate; allow additional time for the practice questions and the final exam. Modules marked optional can be skipped; the others are studied in any order.
Part 1Why the refresher and what changed this yearApprox. 29 min
- Why we refresh GMP every year10 min
Annual GMP refresher training: why the US rules and the EU GMP Guide ask for continuing GMP training, and what this year's edition covers.
What this module covers
Opens with a moment to recall what changed in your own work, then an August 2026 Class I recall where packs labelled as morphine held a syringe of hydromorphone. Explains the two things that change in a year: habits drift, and rules, sites and inspectors' focus move on. Covers what the US rules and the EU GMP Guide ask of continuing training, contrasts a tablet maker in London with a sterile site in Tokyo, introduces JKL Pharma Ltd and outlines the course and its exam. You see how this edition starts with what is new this year, refreshes the essentials with new cases, and ends with an exam. The module closes with a recap: refresh the habit, update the knowledge.
What you will be able to do
- Explain why GMP training is refreshed every year
- Recognise how habits and shortcuts drift between refreshers
- Describe how the EU GMP Guide expects the effect of training to be checked
Why it matters
A label mix-up is an old failure that still reaches patients; a yearly refresh keeps your checks careful every time.
Practice: Practice: Why we refresh GMP every year · 3 questions
- This year in GMP: what changed10 min
This year's GMP regulatory changes: revised EU Annex 19, draft Annex 11, Chapter 4 and Annex 22, US Part 213 medical gases, and when each applies.
What this module covers
Starts with the difference between a final text, which applies from its stated date, and a draft, which you know about but do not apply. Covers the revised EU Annex 19 on reference and retention samples, applying from 24 September 2026, Singapore's listing for active substances and new EU veterinary GMP rules. Then the drafts of Chapter 4, Annex 11 and a new Annex 22, US Part 213 for medical gases and more unannounced foreign inspections. Shows JKL Pharma's response and a Sydney tablet maker that acted on a draft. You see why a draft is something to know about but not yet to apply. The module ends with a recap of the three final changes, the three drafts and the US changes, and a reminder to know the status, then follow your procedure.
What you will be able to do
- Tell a final GMP text from a draft, and when each one applies
- Explain the main change in the revised EU Annex 19
- Check with your quality team before acting on a change
Why it matters
Acting on a draft as if it were final causes as much trouble as missing a final text; knowing the status keeps you right.
Practice: Practice: This year in GMP: what changed · 3 questions
- This year in GMP: findings and recalls10 min
This year's FDA warning letters, an EU GMP non-compliance statement and Class I drug recalls, with the lessons for your own work.
What this module covers
Covers three FDA warning letters from 2026: samples recorded but never taken in Mexico, plates discarded and logbook pages cut out in South Korea, and missing monitoring plates in India. Explains why records of work never done matter so much, then a Croatian statement of non-compliance for an Indian sterile maker and recalls from mix-ups, a leak and cross-contamination. Shows how JKL Pharma used the cases in its own review, and how a tablet maker in Paris and a laboratory in Dubai checked their own practice. You see how JKL checked that its own forms are issued and numbered by quality. The module closes with a recap of the letters, the EU finding of people reaching into the critical zone and unreported deviations, and the recalls the shop floor can stop.
What you will be able to do
- Recognise the pattern behind this year's warning letters
- Explain how a warning letter follows an inspection and a weak response
- Apply another company's findings as checks on your own area
Why it matters
The same mistakes appear year after year at different companies; using their findings helps you prevent your own.
Practice: Practice: This year in GMP: findings and recalls · 3 questions
Part 2Quality system, people, documentation and data integrityApprox. 19 min
- The quality system and people9 min
GMP refresher on the pharmaceutical quality system and people: your role, GMP training and its effect, hygiene, gowning and health reporting.
What this module covers
Opens with the June 2026 warning letter to a sterile maker in South Korea, where an operator's head and upper body were inside the grade A area. Covers the roles of senior management, the quality unit and every person in the quality system, then training before a task and after a procedure changes, checked for effect. Refreshes hygiene, gowning and health reporting, shows how JKL Pharma handled people and hygiene, and looks at a biotech site in Boston and a cream maker in Hong Kong. You see how the quality unit's final say and your own part fit together, and what quality culture looks like: doing it right when nobody is watching, and bad news travelling fast. The module ends with a recap: people are the biggest risk, and the strongest defence.
What you will be able to do
- Describe your own role in the quality system
- Explain when training is needed and how its effect is checked
- Apply hygiene, gowning and health reporting rules before starting work
Why it matters
Equipment and procedures only work through people; your habits on the floor are the strongest defence the product has.
Practice: Practice: The quality system and people · 3 questions
- Documents and data9 min
GMP refresher on good documentation practice (GDocP) and data integrity: corrections, controlled forms, logins, audit trails and backups.
What this module covers
Starts with this year's FDA findings on records: logbook pages cut out and nearly nineteen hundred uncontrolled blank forms in South Korea, an audit trail switched off and no backups in Mexico, and overwritten test reports in India. Refreshes GDocP, including correcting entries under EU GMP 4.9, then data integrity, controlled forms and computer systems. Shows what JKL Pharma found when it checked its own records, and an audit trail at a New York laboratory showing two analysts' work under one login. You see the weak points JKL looked for: missing pages, loose forms, audit trails switched off and backups nobody had tested. A recap closes the module: paper or electronic, the original must survive.
What you will be able to do
- Make and correct entries so the original stays readable
- Use only your own login and keep audit trails switched on
- Check that blank forms and logbook pages are controlled
Why it matters
Paper or electronic, the original must survive; these habits keep your records trustworthy when an inspector picks them up.
Practice: Practice: Documents and data · 3 questions
Part 3Premises, materials, production and the laboratoryApprox. 30 min
- Premises, equipment and cleaning10 min
GMP refresher on premises, equipment, maintenance and validated cleaning procedures, starting from a Class I cross-contamination recall.
What this module covers
Opens with a June 2026 recall of allergy tablets with red dots that turned out to be a different medicine. Covers premises designed and kept in repair to prevent mix-ups and contamination, closed doors and the right air flow, then checking equipment before use and reporting leaks near open product. Refreshes cleaning exactly as the validated procedure says, with logging and signing. Shows what people at JKL Pharma found, a missed filter at a capsule maker in Dublin and a muted pressure alarm in Sydney. You see what people at JKL Pharma found this year when they checked their own areas. The module closes with a recap of premises, equipment checks and cleaning, and the point that controls fail when people stop checking them.
What you will be able to do
- Report damage to premises and doors left open between areas
- Check equipment before use and report leaks near open product
- Clean, dismantle and log equipment as the validated procedure says
Why it matters
Premises, equipment and cleaning are controls, not background; they fail when people stop checking them.
Practice: Practice: Premises, equipment and cleaning · 3 questions
- Materials, production and packaging10 min
GMP refresher on materials receipt and identity testing, production controls and packaging line clearance to prevent label mix-ups.
What this module covers
Opens with three US Class I recalls where packs that looked right held the wrong medicine, the latest in August 2026. Refreshes receipt checks, quarantine, sampling, an identity test on every batch and release by quality, then double-checked dispensing, identified equipment and in-process checks. Covers line clearance, tested readers, on-line checks and label reconciliation. Shows JKL Pharma's Mumbai site testing glycerol for contaminants, packaging events at JKL and a damaged drum label at a plant in Tokyo. You see the checks that stop a pack that looks right from holding the wrong medicine. The module ends with a recap of materials, dispensing and in-process checks, and packaging controls: never trust what you cannot verify.
What you will be able to do
- Keep materials in quarantine until quality releases them
- Apply line clearance and on-line checks on a packaging line
- Reconcile labels before a batch is released
Why it matters
A mix-up can put the wrong medicine in a patient's hands; the checks you make at start-up cost far less than a recall.
Practice: Practice: Materials, production and packaging · 3 questions
- The laboratory and OOS results10 min
GMP refresher on laboratory controls and out-of-specification (OOS) results: reporting, the two-phase investigation and complete lab records.
What this module covers
Starts with this year's warning letter to a sterile maker in South Korea, where a failing result was invalidated using a second sample made with glassware marked for disposal. Explains what an OOS result is, reporting it at once, holding the batch and investigating in two phases, first in the laboratory and then more widely. Covers complete records, raw data and real, counted microbiology plates. Shows an OOS investigation in JKL Pharma's Mumbai laboratory, retesting at a Boston contract laboratory and a settle plate in Paris. If you do not work in a laboratory, you see what happens to the samples you send there. The module closes with a recap: a result is invalidated only with clear, documented evidence. Never test into compliance.
What you will be able to do
- Report an OOS result at once and keep everything
- Explain the two phases of an OOS investigation
- Recognise testing into compliance and refuse to do it
Why it matters
A failing result stands until real evidence shows otherwise; handling it properly protects patients and your site.
Practice: Practice: The laboratory and OOS results · 3 questions
Part 4Deviations, complaints, recalls and inspection readinessApprox. 29 min
- Deviations, CAPA and change control10 min
GMP refresher on deviation management, root cause investigation, corrective and preventive action (CAPA) and change control.
What this module covers
Begins with an April 2026 EU finding where inspectors saw production deviations that nobody had reported, graded as a critical failure. Explains what a deviation is under the US rules and the EU GMP Guide, and what to do in the first minutes: stop, secure the product and evidence, tell your supervisor and record what you saw. Covers root cause, CAPA checked for effect and change control before and after a change. Shows JKL Pharma's cases, repeat retraining in Dubai and an uncontrolled press speed change in Hong Kong. You see how deviations and changes were handled at JKL Pharma this year. The module ends with a recap of reporting, root cause and checked CAPA, and change control before and after a change: fix the system, not just the person.
What you will be able to do
- Tell a deviation from a planned change
- Act in the first minutes after a deviation
- Check that a CAPA fixed the system, not just the person
Why it matters
A deviation nobody reports cannot be fixed; reporting it the same day is how the system stays honest.
Practice: Practice: Deviations, CAPA and change control · 3 questions
- Complaints, defects and recalls10 min
GMP refresher on complaint handling, quality defect investigation and drug recalls, and your part when a complaint reaches you.
What this module covers
Opens with an August 2026 Class I recall of a biologic medicine, after the company's own investigation found glass particles. Covers complaints from any source going to quality the same day, falsified medicine checks, and investigating quality defects for their extent using retained samples and records. Explains recall classes, distribution records and keeping returned stock apart. Shows a complaint JKL Pharma handled about a vial from Singapore, a slow complaint at a Frankfurt distributor and a returned bottle lost in London. You see how the ceftriaxone speck was traced to a rubber fragment from a stopper and the supplier asked to correct its process. A recap closes the module: someone looks, someone reports, the company acts.
What you will be able to do
- Pass every complaint to quality the same day
- Explain how a quality defect is investigated for its extent
- Keep returned stock apart until quality decides
Why it matters
A pharmacist's phone call may be the first sign of a defect in thousands of packs; what you do in the next hour matters.
Practice: Practice: Complaints, defects and recalls · 3 questions
- Inspections and your GMP commitment10 min
GMP refresher on self-inspection and regulatory inspection readiness, five habits for answering an inspector, and your GMP commitment.
What this module covers
Starts with self-inspections under the EU GMP Guide, what they cover and why one that finds nothing has usually not looked hard enough. Covers inspections by FDA, EU and national authorities and customers, including unannounced visits, and how to answer an inspector. Shows an unannounced inspection at JKL Pharma's Mumbai site and monthly self-inspections at a biotech site in Dublin. Ends with your GMP commitment of three written actions, a course recap and the final exam for the Certificate of Completion. You see the questions inspectors often ask on the floor, the five habits for answering them, and why the analyst who said he was not sure was right. The course closes with a recap: readiness is a habit, not an event.
What you will be able to do
- Help a self-inspector see the real picture of your area
- Answer an inspector's questions truthfully and to the point
- Write three GMP actions for the year and share them
Why it matters
Some inspections come without notice; working the same way every day means an inspector sees nothing you need to hide.
Practice: Practice: Inspections and your GMP commitment · 3 questions
Frequently asked questions
Your questions,
answered.
About Annual GMP Refresher Training, its certificate and enrolment.
Ask SterlingIs Sterling Academy a good choice for GMP training?
Yes. Sterling Academy's GMP courses are built by the Sterling consulting group, which has taken organisations to certification across 8,100+ client engagements in 60+ countries over 20+ years. They cover the awareness and specialist levels, always on the current edition, with practice questions that show the right answer. Each course ends with a final exam and a verifiable certificate that anyone can check online, plus a LinkedIn badge, and client administrators can show an auditor exactly who has been trained. You will understand what GMP asks of you, contribute to your organisation's implementation and audit readiness, and play your part with confidence when the auditor visits. Sterling Academy courses carry the same content as Sterling's classroom training, whose certificates are trusted and accepted by all major certification bodies, as evidence of training at client audits for over 20 years.
Awareness: Good Documentation Practice (GDocP) Training · Specialist: Cleaning Validation Training
What is GMP refresher training?
GMP refresher training is periodic training that keeps staff's good manufacturing practice knowledge current after their initial training. This annual refresher covers the year's changes to the rules, recent warning letters, findings and recalls, and the essentials from hygiene and documentation to deviations, complaints and inspections.
Is annual GMP training mandatory?
Continuing GMP training is mandatory, although the rules do not fix the interval. 21 CFR 211.25 in the US and Chapter 2 of the EU GMP Guide require training on a continuing basis and, in the EU, an assessment of its effectiveness. Most sites meet this with an annual refresher such as this one.
What is new in the 2026 edition of the GMP refresher?
The 2026 edition covers the revised EU Annex 19 applying from September 2026, the drafts of Chapter 4, Annex 11 and a new Annex 22, EU veterinary GMP, the US Part 213 for medical gases, FDA's expanded unannounced foreign inspections, and warning letters and Class I recalls from 2025 and 2026.
How long does the GMP refresher training take?
The refresher takes about 2 hours of video across 11 modules, plus practice questions and the final exam. Staff can complete it in one session or module by module between shifts, and the course remembers where each person stopped, so a busy shift never means starting again.
Who needs GMP refresher training?
Everyone who works in or supports a GMP area needs refresher training. That includes production, packaging, warehouse, quality control, quality assurance, engineering and maintenance staff, supervisors and managers in pharmaceutical, biotech and active substance manufacturing, plus contractors who work in those areas regularly.
What is the difference between the GMP refresher and GMP training for operators?
GMP for Operators builds the core shop-floor habits from the start and suits new starters and inductions. The annual refresher is for staff already trained: it is rewritten every year with the latest changes, findings and recalls, then revisits the essentials so knowledge stays current.
Do I get a certificate for the GMP refresher?
Yes, you receive a Sterling Academy Certificate of Completion in your name when you complete the course and take the final multiple-choice exam. One retake is included if the first attempt does not reach the mark, and the certificate can be filed with your annual training records.
How much does the annual GMP refresher cost?
The refresher costs US$19 per learner, including the 11 video modules, practice questions, the final exam and the certificate. Organisations refreshing a whole site or several departments can ask for a company plan; contact us for a quote for your organisation.
Can my whole site take the GMP refresher together?
Yes, a company plan is built for site-wide refreshers. A client administrator adds staff, assigns the course, tracks completion in progress reports and receives one invoice, so you can show an inspector who completed the 2026 refresher and when. Staff in other countries or on other shifts take the same course.
Will the course be updated next year?
Yes, the refresher is rewritten each year. The opening modules on changes, findings and recalls are replaced with the past 12 to 18 months of events, each essentials module gets new cases, and the exam questions are refreshed, so next year's edition is genuinely new for returning staff.
Your certificate
Prove what you learned.
Share it with confidence.
You will understand what GMP asks of you, contribute to your organisation's implementation and audit readiness, and play your part with confidence when the auditor visits. Your certificate can be verified online in seconds, so certification body auditors, employers and clients can confirm your training instantly.
Complete the course and its final exam and you receive a Sterling Academy Certificate of Completion, verifiable online by QR code, with a LinkedIn badge to share.
- Pass mark
- 70%
- Prerequisites
- None
Sterling Academy courses carry the same content as Sterling's classroom training, whose certificates are trusted and accepted by all major certification bodies, as evidence of training at client audits for over 20 years.
Ask about course requirementsYour next step
Not sure which course?