GDP · Good distribution practice for medicinal products (EU, WHO, PIC/S)
GDP compliance consulting for medicines that reach patients exactly as they left the manufacturer.
Store and move medicines the way your authorisation, your principals and the inspector expect: a Responsible Person with real authority, suppliers and customers checked before you trade, storage mapped and monitored, transport lanes you can defend, and returns, recalls and suspect packs handled as the guidelines require. Sterling's expert and experienced consultants work with your warehouse, transport and quality teams in 60+ countries, from gap analysis to inspection and beyond. We ensure a successful GDP compliance programme for our clients.
- Fixed scope, one proposal: consulting, Effivity software, Sterling Academy access and internal auditor training, as applicable to your standard, in one proposal
- A team of expert and experienced pharmaceutical distribution consultants, advising on management systems across sectors and countries since 2003
- The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements. Sterling prepares your distribution quality system and your inspection readiness; the competent authority inspects and decides
8,100+ client engagements in 60+ countries.
GDP client experience
What it is
What is GDP and what is it used for?
Good distribution practice (GDP) keeps a medicine's quality and integrity intact after it leaves the manufacturer, through every business that procures, holds, supplies or exports it on the way to the patient. Regulators set the requirements. In the European Union they are the Commission's guidelines of 5 November 2013 on good distribution practice of medicinal products for human use (2013/C 343/01), based on Articles 84 and 85b(3) of Directive 2001/83/EC, with separate guidelines of 19 March 2015 for active substances (2015/C 95/01). PIC/S publishes its own GDP guide, PE 011-1, and WHO's Good storage and distribution practices for medical products (TRS 1025, Annex 7) extends to vaccines and medical devices, including in vitro diagnostics.
The useful test is practical. Choose any pack in your warehouse: do your records show where it came from, that the supplier and the customer were entitled to trade in it, that it stayed within its labelled storage conditions with you and your carrier, and which customers received its batch if it were recalled tomorrow? A distributor that answers from its own system, for any pack on any day, is ready for inspection; one that needs a week is not.
Current texts. The EU guidelines 2013/C 343/01 have applied since 24 November 2013, replacing the guidelines of 1994 and the version of March 2013; those for active substances since 21 September 2015. The PIC/S guide is PE 011-1 of 1 June 2014, with an aide-memoire for GDP inspections, PI 044-1, added in February 2023; WHO's guideline dates from 2020. Pack verification under Delegated Regulation (EU) 2016/161 has applied since 9 February 2019, with a later start allowed for certain Member States. Which GDP text applies to your business
Who it is for
Who needs GDP compliance?
In EU terms, wholesale distribution means procuring, holding, supplying or exporting medicinal products, apart from supplying the public, and it needs a wholesale distribution authorisation from the competent authority of the Member State where it takes place. GDP therefore reaches wholesalers, importers, parallel distributors, manufacturers distributing their own products and pharmacies that also supply other businesses. Brokers, who never handle the product, are registered rather than authorised; distributors of active substances have their own guidelines. Warehouses, carriers and forwarders working for any of them are contract acceptors, bound by contracts and audits. Organisations come to Sterling for GDP from four starting points:
- You are applying for a wholesale distribution authorisation. The application is judged on the premises, the quality system and the Responsible Person, so procedures, mapped storage and trained people must exist before the first pack arrives.
- A manufacturer or wholesaler wants to contract you. A contract giver must assess your competence and audit you before the work starts and whenever it changes. A warehouse or forwarder without GDP procedures, mapping reports and training records does not pass.
- An inspection or a principal's audit found deficiencies. Temperature control, partner checks, returns or self-inspection, each with a response date; in the EU a serious outcome is a statement of non-compliance in EudraGMDP instead of a GDP certificate.
- Your operation changed and the system did not. Refrigerated or controlled products added, a new warehouse or carrier, exports to third countries, pack verification, or growth beyond what one Responsible Person can oversee.
The goal: an inspector or a principal's auditor can arrive, choose any consignment and follow it through your records without help, which only a system in daily use can deliver.
Business benefits
How GDP compliance protects patients and wins distribution contracts
The return on GDP shows up as stock you do not write off, audits that end without a list of deficiencies, and principals who hand you more of their portfolio. We start where products are most exposed.
- Less stock written offMapped storage, tested alarms and excursions assessed promptly, so product is released or rejected on evidence, not destroyed on doubt.
- Contracts you can winDocumented GDP, assessed lanes and audit-ready records answer a principal's questionnaire before it arrives.
- Falsified packs stopped at the doorSuppliers and customers checked with due diligence, packs verified where the safety-features rules apply, suspect stock segregated and reported at once.
- Recalls that reach every customerRecords that trace each batch to its recipients, and recall arrangements evaluated for effectiveness at least once a year.
- A Responsible Person who can decideAuthority written into the job description, delegations recorded, and the facts behind each supplier, customer and return decision in one place.
- Clear lines with carriersAgreements that settle who monitors, who reports and who decides, so a deviation in transit reaches the distributor and the recipient.
Track a few measures that show control: excursions and how fast they close, returns restocked with full evidence, recall test results and the age of open findings. More procedures are not progress; fewer unexplained excursions are.
Requirements
What are the main GDP requirements?
The EU guidelines run to ten chapters; WHO's 2020 guideline covers similar ground in twenty-one sections, and national rules add detail. The table maps the ten chapters plus two EU companion texts, for active substances and for pack safety features; during the programme your operation is checked against the text your regulator applies, section by section.
| Chapter | What it requires of you | What it looks like in practice |
|---|---|---|
| 1 Quality management | A documented quality system with clear management responsibilities; deviations investigated and CAPA taken; change control; outsourced activities controlled; periodic management review; quality risk management | Deviation, change and CAPA logs, proportionate risk assessments, a management review with decisions |
| 2 Personnel | A designated Responsible Person who carries the responsibilities personally and is continuously contactable; enough competent staff; GDP training before and during the job, with specific training for products needing stricter handling; hygiene | The Responsible Person's job description with decision authority, recorded delegations, a training programme and records for every role |
| 3 Premises and equipment | Secure premises of sufficient capacity that maintain the required storage conditions; storage mapped under representative conditions before use and again when risk or change requires; alarms tested; calibration; computerised systems validated | Mapping reports, monitoring and alarm records, calibration traceable to national or international standards, validated systems |
| 4 Documentation | Written, controlled procedures and records, made at the time of each activity and kept for the period national law sets, at least five years | Controlled procedures, a record for every transaction, retention applied by rule |
| 5 Operations | Supply only from authorised suppliers and only to authorised or entitled customers, checked with due diligence; controlled receipt, storage on first expiry, first out, destruction, picking, supply and export | Partner qualification files, receipt checks, recorded exceptions to rotation, batch numbers on delivery notes where safety features apply |
| 6 Complaints, returns, suspected falsified medicinal products and medicinal product recalls | Complaints investigated; returns restocked only when every condition is met; suspected falsified products segregated and reported at once to the competent authority and the marketing authorisation holder; recall effectiveness evaluated at least annually | A complaint log, return assessments with storage evidence for cold-chain products, a dedicated area for suspect stock, recall tests |
| 7 Outsourced activities | A written contract; the contract giver assesses the contract acceptor's competence and audits before the work starts and after changes; no subcontracting without the contract giver's evaluation and approval | Quality agreements with warehouses and carriers, pre-contract and change audits, performance reviews |
| 8 Self-inspections | A programme covering all aspects of GDP within a defined time frame, conducted impartially by designated competent staff, recorded, with causes found and CAPA followed up | A self-inspection plan across every chapter, reports, CAPA tracked to closure |
| 9 Transportation | The supplying distributor protects products against breakage, adulteration and theft and keeps temperature within limits in transit; transport planned on risk; excursions and damage reported; qualified equipment for temperature-sensitive products | Lane risk assessments, qualified packaging or vehicles, vehicle mapping that reflects seasonal variation, logger data reviewed |
| 10 Specific provisions for brokers | Registration, with a permanent address and contact details in the Member State; a written quality system with an emergency plan for recalls; staff trained in EU and national law and on falsified medicines; records kept at least five years | A registration, broker procedures, checks that partners are authorised and products hold a marketing authorisation |
| 2015/C 95/01 GDP for active substances | Registration under Article 52a of Directive 2001/83/EC for EU importers and distributors; a quality system with a designated person at each location; records kept at least one year after expiry, or three years after complete distribution where a retest date applies | Registration, supplier checks, receipt checks on seals, labels and certificates of analysis |
| 2016/161 Safety features (EU) | Verify unique identifiers where the regulation requires, including returned packs; decommission packs exported outside the Union, destroyed or unfit to restock; never supply a pack suspected of tampering or falsification | Verification and decommissioning built into receipt, returns and export; suspect packs quarantined and reported |
What does useful GDP evidence look like?
Supplier and customer qualification files; mapping reports with monitoring and alarm records; calibration certificates; lane assessments and logger downloads; deviation, excursion and CAPA logs; return decisions with their storage evidence; recall tests; complaint files; contracts and audits for every warehouse and carrier; self-inspection reports; and training records, the Responsible Person's included. We identify the records your operation needs, without procedures nobody follows, and they live in Effivity from the first workshop, so the inspector sees a system in use.
The ten GDP chapters explained, with examplesCompliance process
How do you become GDP compliant?
No consultant can hand over GDP compliance, and no private certificate confers it. It is established when the competent authority grants your authorisation and finds on inspection that you meet the guidelines. Sterling builds the system and the evidence with you; the authority inspects and decides.
- 01Define the activities, products and sites in scope.Wholesale, import, export, brokering, or storage and transport for others; ambient, refrigerated or controlled products; every site, carrier and responsible authority.
- 02Gap analysis: review the operation against the applicable GDP text.The gap analysis walks the warehouse, the vehicles and the records chapter by chapter, keeps what works and gives every action an owner, a date and a risk rating.
- 03Build the system, then qualify storage and transport.Procedures, the Responsible Person's framework, partner qualification, mapping, monitoring and alarms, calibration, validated systems, carrier agreements and training.
- 04Self-inspect, review and close the findings.A self-inspection across every chapter, a mock inspection, a recall test and a management review; we raise findings before any inspector does, and each closes on evidence.
- 05Host the inspection and answer the deficiencies.The authority's inspection for the authorisation or a routine visit, or a principal's audit; deficiencies answered with CAPA inside the deadline, then the authority's decision.
- 06Stay compliant between inspections.Excursion reviews, re-mapping after change, partner re-checks, carrier audits, self-inspections and refresher training, alongside the authority's re-inspections.
Judge an offer by what it builds, not by the paper it promises. In the EU the GDP certificate comes from the competent authority after inspection and is entered in EudraGMDP. Treat a "GDP certificate" offered by a certification body as a voluntary audit result: it may help with a customer, but it is not the authority's certificate and does not replace your authorisation. Ask any provider which gaps they will close and which records you will own. How to choose a credible GDP provider · The compliance buyer's checklist
Cost
How much does GDP compliance cost?
GDP has no accurate list price. A single ambient warehouse preparing its first authorisation needs a different programme from a multi-site distributor adding cold chain, or a forwarder facing several principals' audits. What we commit to is a proposal with every component visible and a fixed consulting fee.
| Cost component | What affects it |
|---|---|
| Consulting and implementation | Current maturity, warehouses and cross-docks, product categories, own fleet or carriers, deliverables and how much of the work your team takes on (Design™ or Drive™) |
| Mapping, monitoring and qualification | Mapping studies, monitoring and alarm systems, qualified packaging or vehicles and calibration, sized by the gap analysis and listed separately |
| Regulatory fees | Authorisation, registration and inspection fees where your authority charges them, shown separately so programmes compare like for like |
| Internal resources | Time from the Responsible Person, operations and quality staff for drafting, review, training and changes on the floor |
| Software and learning | Included in a Sterling engagement: Effivity to run the system and Sterling Academy access for your staff, with users, courses and access period confirmed in the proposal |
| Continued support | Self-inspections, carrier audits, re-mapping after changes, refresher training and support at re-inspection, under Sustain™ |
What moves the price
- Number of sites, and whether they store, cross-dock or only broker
- Ambient products only, or refrigerated, controlled or hazardous products too
- Own vehicles, contracted carriers or both, and the lanes they run
- The state of mapping, monitoring and qualification today
- Open inspection or audit deficiencies and their deadlines
What a Sterling proposal always shows
- Deliverables, responsibilities, assumptions and exclusions, in writing
- Mapping studies, monitoring hardware and authority fees identified separately
- Effivity, training and Academy access itemised at no additional cost
- Payment milestones tied to deliverables, not to the calendar
- One all-inclusive proposal. No surprises, ever
Timeline
How long does GDP compliance take?
Most distribution operations need three to nine months before an inspection: the short end where premises and systems are sound and the gaps are procedural, the long end where storage must be mapped or re-mapped, monitoring installed or carriers qualified. Mapping sets the pace, because it must reflect representative conditions, and records need time to accumulate: excursions handled, returns decided, a recall tested, a self-inspection closed. The plan works back from the records an inspector is likely to sample, and each milestone is tracked in Effivity.
| Phase | What determines the pace |
|---|---|
| Scope and gap analysis | Access to the warehouses, vehicles, contracts, monitoring data and earlier inspection or audit reports |
| Build and implementation | The procedures and training needed, the Responsible Person's availability and any changes to premises, monitoring or carriers |
| Qualification and evidence | Mapping schedules, equipment qualification, carrier audits and the time the system needs to run, followed by self-inspection and management review |
| Regulator or customer review | The competent authority's scheduling of the authorisation or routine inspection, principals' audits and the time needed to answer deficiencies |
If an authorisation, a tender or a new principal depends on the programme, give us the date on day one. We will say plainly what can be achieved and which decisions have to be taken early; no one should promise an inspection result before seeing your warehouse.
Challenges
Common GDP implementation challenges
Five problems stall most GDP programmes, and each has a practical answer.
Temperature excursions nobody can explain.
Alarms acknowledged hours after they sound, loggers read weeks later, and "no impact" written without data. We set alarm response rules, link each excursion to the principal's stability information, and make every release or rejection traceable to someone entitled to decide it.
The Responsible Person has the title but not the authority.
The guidelines expect the Responsible Person to carry the responsibilities personally, stay continuously contactable and hold decision authority in the job description. We define the role, record delegations and route supplier approvals, returns and recalls through them in Effivity.
Carriers and 3PL warehouses sit outside the system.
Transport is where control is most often lost. We write quality agreements that assign monitoring, reporting and decisions, audit carriers before work starts and after changes, and assess each lane for temperature and security risk.
Returns go back into stock on trust.
Restocking is allowed only when every condition in the guidelines is met, and the decision sits with the Responsible Person. We turn the conditions into a checklist signed before anything is resold.
Supplier and customer checks stop after the first order.
Authorisations lapse, and an unusual offer can be the first sign of falsified stock. We schedule periodic re-checks and train purchasing staff in the warning signs the guidelines list, such as unusually large quantities or prices out of line with the market.
Your engagement
What your GDP engagement includes
Your agreed scope covers what a compliant operation and a trained workforce need. Many providers leave a procedure set behind; a Sterling engagement covers the whole route, from one team under one all-inclusive proposal.
Scope, gap analysis and implementation plan
Activities, sites, products, carriers and the applicable GDP text, with every gap given an owner, a date and a decision maker before work starts.
Distribution quality system and documentation
Quality manual, procedures and records on Sterling's own template sets, written with your Responsible Person and operations leads, quality risk management built in.
Effivity ISO & GRC software
Your GDP system runs in Effivity from day one, included with the engagement at no additional cost.
Training for everyone
Internal auditor training for the staff who will run self-inspections, as applicable to your standard, and preferential Sterling Academy access, including complimentary awareness training for your people as part of the engagement.
Self-inspection and management review
A self-inspection across every chapter and a management review, conducted or facilitated as agreed, with findings closed on evidence before the inspector arrives.
Inspection readiness and support
A mock inspection, a recall test, your team briefed for inspection day, and support with the response to deficiencies until they close.
Authorisations, inspection outcomes and GDP certificates remain decisions of the competent authority.
How we deliver
How Sterling supports your GDP implementation
Every GDP engagement runs on Sterling OS™, our delivery operating system: five phases, each with defined deliverables, decision owners and evidence. Pick the support level that fits your capacity; the method, the software and the accountability stay constant.
- 01Design™Guided implementation: your Responsible Person and team build the system with Sterling's structure, templates, workshops and coaching.
- 02Drive™Fully managed consulting: Sterling consultants carry the agreed work, from gap analysis and mapping plans to carrier agreements and training.
- 03Sustain™After the inspection: self-inspections, carrier audits, excursion trend reviews, refresher and new-starter training, and support at re-inspection.
- 04Automate™The GDP system in Effivity: procedures, training, partner qualification, deviations, CAPA, returns, recalls, audits and management review in one workspace.
- 05Revise™Revisions of the EU, PIC/S or WHO texts, and changes in your products, sites, carriers or markets.
The first working session fixes the Sterling lead, the weekly rhythm, the deliverables and who approves them. We report against that plan every week, so slippage surfaces while there is time to recover it.
How Sterling OS™ worksOften combined with
Standards organisations pair with GDP
- AEOAuthorised Economic Operator (AEO) readiness: what customs examines, who can apply and how Sterling prepares your controls and evidence for the customs visit.
- BRCGS Storage and Distribution · Agents and BrokersBRCGS Storage and Distribution certification and Agents and Brokers: Issue 4 and Issue 3 requirements, scopes, audits and cost factors, with Sterling's support.
- C-TPATC-TPAT requirements and validation readiness for US importers and overseas suppliers: the Minimum Security Criteria, CBP's process and how Sterling helps.
- CBAMCBAM compliance and requirements explained: authorised declarant status, the 50-tonne threshold, verified embedded emissions and how Sterling helps you prepare.
- EcoVadisEcoVadis rating consulting: evidence on environment, labour and human rights, ethics and sustainable procurement, prepared for the assessment EcoVadis runs.
- EU Deforestation Regulation (EUDR)EUDR compliance and requirements for cattle, cocoa, coffee, palm oil, rubber, soya and wood: due diligence, risk assessment and the 30 December 2026 date.
Effivity · GDP quality management software, included in every engagement
How Effivity helps you fulfil, automate and simplify the requirements of the EU GDP Guidelines (2013/C 343/01) and the PIC/S GDP Guide (PE 011-1).
Every Sterling GDP engagement includes Effivity, the ISO and GRC automation platform built by the Sterling group and used in 50+ countries. Your consultant configures the workspace within the agreed scope, so procedures, training, partner qualification, excursions, CAPA, returns, recalls, carrier audits and self-inspections sit in one place, and an inspector reviews live records rather than binders. Sterling consulting clients get their Effivity subscription included with the engagement, at no additional cost.
Deviations, CAPA and management review
Deviations logged as they happen and closed with CAPA, changes risk-assessed before approval, and a management review fed by the year's data.
The Responsible Person, roles and training
Job descriptions with decision authority, delegations on record, a training matrix by role and assessed GDP training, so each person's file is complete before anyone asks.
Mapping, monitoring and calibration
Storage areas with their mapping reports and re-mapping triggers, monitoring points, alarm tests and calibration due dates for every probe and logger, overdue items flagged to their owners.
Procedures, records and retention
Controlled procedures with versions, approvals and linked training, records made at the time of the activity, and retention applied by rule for at least the five years the EU guidelines set.
Supplier and customer qualification
Each partner's authorisation check, due diligence notes and re-check date in one register, so an order from a party that is not qualified shows before it ships.
Complaints, returns, suspect stock and recalls
Returns assessed against every restocking condition with the Responsible Person's decision recorded, suspect packs logged with the notifications made, and recall tests evaluated each year.
Self-inspection programme and follow-up
A plan covering every chapter within a defined period, impartial inspectors, reports with causes and CAPA, and follow-up recorded to closure.
Carriers, lanes and excursions
Contract acceptors assessed and audited before work starts and after changes, lane risk assessments, and every transport deviation or excursion reported and closed with its decision.
What this means at the audit
An inspector picks a consignment and asks for its temperature record, the customer's authorisation check, the latest mapping report for the area where it was stored and the training record of the person who picked it. In Effivity each is a screen, dated, owned and linked, not a search through e-mail and shared drives. Where it holds GDP records, Effivity is itself a computerised system and is validated for its intended use like any other. Once the inspection is over, the same workspace carries Sustain™.
In your engagement
- Subscription included with the engagement, at no additional cost
- Configured by your Sterling consultant within the agreed scope
- Your procedures, registers and logs migrated, not retyped
- Admin and user training for your team
- Modules for QMS, EMS, OHSMS and more when you integrate other standards
GDP client experience
Client letters on file, available on request.
Signed client letters for GDP are available on request. The client feedback wall lists every letter by standard.
Case study with GDP in scope
GDP inside an integrated logistics programme.
- 01Read the case study
Logistics and transportation: end-to-end traceability and a smaller footprint
A logistics and transportation company needed end-to-end traceability and a smaller environmental footprint. It implemented ISO 9001, ISO 14001, ISO 45001 and ISO 28000 with GDP and GWP, using Sterling's software tailored to its operation. Live tracking, recorded quality checks and simpler reporting to customers raised satisfaction and won more contracts, and data-led fuel efficiency and better routes cut its environmental impact; its operations director said the company had achieved its certifications and transformed how it operates.
Sterling Academy · GDP e-learning
Train every employee on GDP, not only the Responsible Person.
The EU guidelines expect GDP training for everyone in wholesale distribution, before they start and throughout their role, and specific training for products that need stricter handling. Sterling Academy delivers e-learning for the whole workforce and for the people who run the system: video lessons with practice checkpoints, a final exam and a numbered Certificate of Completion for each learner, verifiable online. Sterling consulting clients benefit from preferential course access and special pricing through their Sterling consultant, including complimentary awareness training for their people as part of the engagement.
- GDP awareness for warehouse, transport and quality staff, with the training records the guidelines expect
- Practitioner courses for the Responsible Person, supervisors and document owners
- Internal auditor training for the people who will conduct self-inspections, as applicable to your standard, as part of the engagement
- Learner progress by site and shift, and a training status report ready for the inspector
- New starters trained before they handle product, so records are current at every inspection
- A Sterling consultant reachable when a learner needs one
Sterling Academy courses for a GDP programme
The courses your people take, and who takes them.
GDP Awareness
What GDP asks of everyone who receives, stores, picks, ships or delivers medicines: storage conditions, excursions, suspect packs, returns, and why a warehouse shortcut becomes a patient risk. The training evidence for the whole workforce.
View the courseDocumented Information Management
Writing, approving and controlling procedures and records so every transaction leaves a complete, contemporaneous and retrievable trail, on paper or in a system.
View the courseNonconformity Management
Recording and investigating deviations, temperature excursions and complaints, finding the real cause, and closing CAPA with evidence that the fix worked.
View the courseRisk Management
Quality risk management applied to distribution: assessing lanes, partners and storage, and matching effort and documentation to the level of risk.
View the courseInternal auditor training
Delivered by your Sterling consultant for the people who will conduct self-inspections, with exercises on your own warehouse, carriers and records, and a Certificate of Competence.
Integrating other standards?
Awareness courses for ISO 9001, ISO 14001, ISO 45001, ISO 13485 and more, so a distributor that combines GDP with certified management systems trains one workforce on one platform.
See all coursesSterling consulting clients arrange access through their consultant. An Academy certificate records a person's training; it says nothing about your authorisation, which only the competent authority grants and inspects.
Keep exploring
Explore more about GDP
Watch a video on how to implement good distribution practice for medicines here.
Watch a video on good distribution practice requirements here.
Why Sterling
Want successful GDP compliance? Come to Sterling.
Whether you run one warehouse or a regional network of cross-docks, carriers and brokers, Sterling builds a distribution quality system that satisfies your competent authority and the principals who trust you with their products, reconciling EU, PIC/S, WHO and national texts with quality agreements and the realities of a night shift.
Across 60+ countries since 2003
Distributors, logistics providers and manufacturers supported in several regions, with one engagement team accountable for every site and lane in scope.
All-inclusive proposal
Consulting, Effivity, training and Academy access in one proposal, with mapping studies, monitoring hardware and authority fees identified separately. No surprises, ever.
A system your warehouse can run
Short, clear procedures and records built into the tools your people already use, so the night shift follows the system instead of working around it.
Expert and experienced consultants
Consultants with management system consulting across sectors and countries since 2003, who get your distribution quality system right first time, so the inspector finds control already working.
The Sterling Promise
What our GDP compliance success guarantee means
We stay with you until your agreed GDP outcome is achieved: the system built, the evidence in place, and the authorisation inspection, routine inspection or principal's audit your engagement names supported until its deficiencies are closed. Clear explanations, practical delivery, included software and employee learning turn the investment into lasting capability, not a folder of procedures.
The engagement identifies the GDP text, scope, outcome and responsibilities. Your organisation supplies accurate information, funds and carries out the agreed changes to premises, monitoring and carriers, and puts the agreed controls into use. The competent authority inspects and keeps its decisions on authorisations and GDP certificates. Our commitment concerns the agreed compliance support, not a particular inspection outcome or a promise that no excursion will ever occur.
After the inspection
What happens after you become GDP compliant?
An authorisation is not a finishing line. The authority returns, principals re-audit, and every change of warehouse, carrier, product range or customer reopens a question the last inspector closed. Between visits the system keeps working: excursions assessed, partners re-checked, carriers audited, recalls tested and new people trained.
Under Sterling OS™ Sustain™ we review excursions, deviations, returns and audit findings with you alongside the planned self-inspections and management reviews, so the operation is ready on any working day. When the EU, PIC/S or WHO texts change, Revise™ turns the change into a dated plan.
FAQs
Frequently asked questions about GDP
Is there such a thing as GDP certification?
Not in the regulatory sense from a certification body. In the EU, the competent authority that inspects a wholesale distributor issues a GDP certificate, or a statement of non-compliance, and enters it in EudraGMDP; the right to trade comes from the wholesale distribution authorisation. Voluntary schemes such as IATA's CEIV Pharma sit beside that route, and a "GDP certificate" from a certification body is a voluntary audit result: possibly useful to a customer, never a substitute for the authority's decisions.
Who needs a wholesale distribution authorisation?
In the EU, anyone who procures, holds, supplies or exports medicinal products other than to the public, from the competent authority of the Member State concerned. Brokers register instead. Outside the EU the names and thresholds differ, so we confirm them against your national rules at the start.
Does GDP apply to 3PLs, transport companies and freight forwarders?
Through the distributor, always. The supplying distributor stays responsible for protecting products in transit, temperature included, and must assess and audit the warehouses and carriers it contracts. A contract acceptor needs suitable premises, equipment, procedures, knowledge and competent staff, and may not subcontract without the contract giver's approval. Whether a logistics provider also needs its own authorisation depends on its activities and on national law.
What does the Responsible Person do?
The Responsible Person makes sure a quality management system is implemented and maintained, and carries responsibilities including training, recalls, customer complaints, approving suppliers, customers and subcontracted activities, making sure self-inspections happen, and deciding the final disposition of returned, rejected, recalled or falsified products. They must be continuously contactable and may delegate duties but not responsibilities. The EU guidelines call a degree in pharmacy desirable; national law sets the qualification.
How do temperature-sensitive products change the requirements?
Storage is mapped under representative conditions before use and re-mapped when risk or significant change requires, with monitoring where the mapping found the extremes. In transit, qualified packaging, containers or vehicles are used, vehicle mapping reflects seasonal variation, and excursions are reported to the distributor and the recipient. Cold-chain returns need documented evidence that storage conditions held throughout.
Can returned medicines go back into saleable stock?
Only when every condition is met: secondary packaging unopened and in good condition, the product in date and not recalled, the customer able to show correct storage and handling, examination by a trained and authorised person, and reasonable evidence that you supplied it and that it is not falsified. Returns from customers without a wholesale authorisation, such as pharmacies, must arrive within an acceptable time limit, which the guidelines illustrate as ten days. Stolen products that have been recovered can never be restocked and sold.
What do the EU safety-features rules require of wholesalers?
Delegated Regulation (EU) 2016/161, applicable since 9 February 2019, puts a unique identifier and an anti-tampering device on the packs within its scope. Wholesalers verify identifiers in the cases it sets, such as returned packs; decommission packs they export outside the Union, destroy or cannot restock; and must not supply a suspect pack, informing the competent authorities immediately.
How do the EU, PIC/S and WHO GDP texts differ, and what about veterinary medicines?
The EU guidelines, 2013/C 343/01, apply to wholesale distribution of human medicines in the EU, in ten chapters. PIC/S publishes its own GDP guide, PE 011-1 of June 2014, and a GDP inspection aide-memoire. WHO's 2020 guideline covers medicines, vaccines and medical devices in twenty-one sections and is written to be adapted to national conditions. Veterinary medicines have their own EU text, Commission Implementing Regulation (EU) 2021/1248 of 29 July 2021 under Regulation (EU) 2019/6. Your authority decides which text it inspects against.
Does Sterling inspect or certify our GDP compliance?
No. Sterling designs and builds the system with you, runs or facilitates your self-inspections and a mock inspection, and helps you answer any deficiencies. Inspection and the resulting decisions belong to the competent authority, and your principals' auditors form their own view.
Before the first call
Prepare a useful GDP readiness brief
You do not need to write anything before the first conversation. A short description of what you store and move, where and for whom, organised around seven questions, is enough:
- Which activities are in scope: wholesale, import, export, brokering, or storage and transport for others, and at which sites?
- Which products do you handle: ambient, refrigerated or frozen, controlled or hazardous, finished medicines or active substances?
- Which authority authorises you, which GDP text does it apply, and when is the next inspection or renewal?
- What did your last inspection or principal's audit find, and what is still open?
- How are storage conditions mapped and monitored today, and how are excursions handled in the warehouse and in transit?
- Which warehouses, carriers or forwarders do you contract, and are agreements and audits in place for each?
- Who is your Responsible Person, who else can give time, and is there an authorisation, tender or principal's deadline?
Your answers let us scope the programme and price it fairly. They are the start of a discussion, not a scored assessment and not a finding on compliance.
Don’t be fooled by certification scams
If it takes ten days, it is not GDP compliance.
GDP is proved by records built up over months and by an authority's inspection, so the market offers substitutes: "GDP certified" seals from bodies with no regulatory role, warehouses sold as temperature-controlled with no mapping behind the claim, and procedure packs with another distributor's name still in the footer. They cost little, until a principal's auditor, an importing authority or a recall asks for the evidence behind them.
How to choose a credible GDP provider
- Ask who issued the certificate. In the EU, GDP certificates are issued by competent authorities after inspection and entered in EudraGMDP; a certificate from anyone else is at most a voluntary audit result.
- Check the authorisation, not the logo. Confirm a trading partner's wholesale distribution authorisation or broker registration directly with the authority that granted it.
- Ask to see the mapping. A temperature-controlled warehouse or vehicle without a mapping report, monitoring records and tested alarms is a claim, not a control.
- Ask how carriers and subcontractors are controlled. Written agreements, audits before work starts and excursion reporting should exist for every one of them.
- Ask what your people will learn and which records you will own. Everyone involved in distribution activities needs GDP training; a framed certificate trains no one.
- Walk away from "GDP certified in 7 days", "certificate included" and one invoice for consulting and certificate. A distribution quality system has to run before anyone can inspect it.
Keep exploring
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