الإتحاد العربي لمنتجي الأدوية والمستلزمات الطبية
الذراع التقنية لاتحاد المصنّعين نفسه · مكتبٌ واحد للـ GMP والتسجيل والتكافؤ الحيوي وسلاسل التوريد عبر أسواق الوطن العربي الاثنين والعشرين. الاتحاد قائم منذ 1986، والمكتب تأسّس في 3 مايو 2026.
Chairman · Associate Prof. Dr. rer. nat. Osama Abd Elrahman — Drug Affairs Consultant
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When manufacturers and authorities need a neutral technical reference, it comes from inside the industry's own union — not from a firm selling into it.
The Office is the technical arm of the Arab Union of the Manufacturers of Pharmaceuticals and Medical Appliances, in operation since 1986. Its board comes from drug authorities, industry and academia — including former unit heads at Egypt's EDA.
A registration, GMP or supply question rarely stops at one border. The Office works across all 22 Arab League states and maps every file to PIC/S PE 009 and PE 011 — the standard an EU or SFDA inspector reads from.
A live GMP inspection dashboard, a Monte-Carlo supply-resilience studio, a 363-substance API and excipient data bank, a 375-entry reference-product register, and a 17-board expert forum carrying 123 bilingual technical discussions — built in-house, free to open.
Use them now ↓Development strategy, inspection readiness, bioequivalence design, CTD/eCTD dossiers, biosimilars and market access — one panel of senior experts carries a product the whole way, instead of handing it between four firms.
Support, develop and localise the pharmaceutical and medical-device industry across all Arab countries — uniting manufacturers and medicines authorities on a single platform.
دعم وتطوير وتوطين صناعة الأدوية والمستلزمات الطبية في كافة دول الوطن العربي، وجمع المصنّعين والسلطات الدوائية على منصة واحدة.
Provide specialised technical consultancy across the fields of the pharmaceutical industry.
تقديم الاستشارات الفنية المتخصصة في مجالات صناعة الدواء.
Develop Arab human capital through specialised training programmes.
تطوير الكوادر البشرية العربية من خلال برامج تدريبية تخصصية.
Contribute to drafting unified pharmaceutical guidance, in coordination with regulatory authorities.
المساهمة في صياغة الأدلة الاسترشادية الدوائية الموحدة بالتنسيق مع الهيئات الرقابية.
Provide a platform for technical arbitration and review of technical disputes in the pharmaceutical sector.
توفير منصة للتحكيم الفني وفحص النزاعات التقنية في القطاع الدوائي.
Established 2026 — a founding board drawn from regulatory authorities, industry and academia across the Arab world.
Drug Affairs Consultant
Consultant in regulatory affairs & due diligence
Pharma regulatory & business expert
General Manager, PharmaPrime
Ex-GM, General Administration of Reference Laboratories, EDA
Biologicals / synthetic peptides / E&L expert · former Head of Biosimilars Unit, EDA
Medical device expert · former head of the diagnostics unit, EDA
CEO — Bara'a for Pharmaceutical Patent Consultation
نخبة متعددة التخصصات من كبار الخبراء · وفي تنامٍ مستمر.
الشؤون التنظيمية
الجودة وممارسات التصنيع
التحاليل ومراقبة الجودة
التكافؤ الحيوي والسريري
التيقظ الدوائي
الأجهزة الطبية
التقانة الحيوية والمماثلات الحيوية
براءات الاختراع والملكية الفكرية
المواءمة
A reference is not built on claims. It rests on two things: knowing where every number comes from and when, and keeping your data in your own hands. Here is how we hold to both.
Every figure carries its source and the date it was checked. Anything estimated or press-reported is labelled as such, and the moving constants in the tools show a live status — codified, final, draft, or withdrawn. Where nothing citable exists, we say so.
The studios and calculators run on your device. The molecule names, batch numbers, prices and dossiers you type are never uploaded, stored, or seen by us. Only a form you choose to submit — membership, the newsletter, a message — sends anything, and only what you put in it.
Found an error? One email fixes it. Every dataset is dated, so you can see when it was last checked and hold us to it.
Report an error ↗We build on primary sources, not secondary summaries: EU GMP and PIC/S, the FDA and EMA, WHO and ICH, the SFDA and the Arab national regulators, official gazettes, the Orange Book and public assessment reports.
A named founding board of eight, drawn from regulatory authorities, industry and academia, working under the Arab Union of the Manufacturers of Pharmaceuticals and Medical Appliances, established in 1986.
Meet the board ↗We don't invent a number to look complete, we don't dress an estimate as a fact, and we don't hide the tools behind a login. When there is a gap, we name it.
A question about a number, a source, or your own data? Write to the Chairman directly.
o.abdelrahman@aupam.orgA reference has to keep running after the attention moves on. Two things give this one its durability: the data refreshes itself from primary sources on a published schedule, and every domain has a named committee accountable for it.
Not a snapshot made once, but machinery that runs. Each feed is re-derived from its primary sources, de-duplicated, and source-verified.
Each domain answers to a committee led by a named expert, not an anonymous inbox.
Every feed carries its sources and its dates, and is rebuilt from public primary data. So any qualified team can check it, reproduce it, and maintain it — the reference does not live in one person's head. Corrections are logged and dated.
As the technical arm of a union of manufacturers, the Office supports companies from development through inspection readiness to market access.
الجاهزية للتفتيش والـ GMP
Mock audits, gap assessment and CAPA against PIC/S PE 009.
التسجيل · CTD / eCTD
Module 1–5 dossier preparation, review and deficiency response.
التكافؤ الحيوي والسريري
BE study design, protocol and clinical study-report review.
نظم الجودة وسلامة البيانات
PQS, ALCOA+ and lifecycle validation support.
المماثلات الحيوية والأجهزة الطبية
Development strategy and market-access pathways.
تدريب مؤسسي مخصّص
In-house programmes for QA, RA and production teams.
تدريب الجهات التنظيمية
Structured programme launched to support sister authorities — first cohort: the Syrian Ministry of Health.
مرجعية متوائمة مع PIC/S
Positioning AUPAM as the Arab technical reference bridge — mapping training and inspection to PE 009 / PE 011.
قدرات المفتشين العرب
Building inspector competence and quality-system readiness for authorities preparing pre-accession applications.
Three formal positions filed in a matter of weeks to top-tier standard-setters whose guidance is adopted — often verbatim — across the Arab League, the Gulf and MENA.
General Considerations for the Use of New Approach Methodologies (NAMs) in Drug Development
اعتبارات عامة لاستخدام منهجيات النهج الجديدة (NAMs) في تطوير الأدوية
Docket FDA-2025-D-6131-0002
Guideline on Non-Inferiority & Equivalence Comparisons in Clinical Trials
مبدأ توجيهي لمقارنات عدم الدونية والتكافؤ في التجارب السريرية
EMA/301654/2025 · via EUSurvey
Bioequivalence for Immediate-Release Oral Dosage Forms (Working Document)
التكافؤ الحيوي للأشكال الفموية ذات التحرر الفوري
QAS/25.990 · via PleaseReview™ · before 23 Jun 2026
On 11 June 2026, WHO Geneva invited AUPAM — through the Arab Experts' Office — to its Consultation on Good Practices for Health Products Manufacture & Inspection (1 July 2026).
دعت منظمة الصحة العالمية بجنيف الاتحاد عبر مكتب الخبراء العرب للمشاركة في مشاورتها حول الممارسات الجيدة لتصنيع المنتجات الصحية · 1 يوليو 2026.
From the Atlantic to the Gulf, the Experts' Office connects the manufacturers and medicines authorities of every Arab League member state. Tap a nation to see its national medicines regulator.
Arab Regulatory Atlas · v1.0 (July 2026). Authorities and their international standing were verified against official regulator sites and the PIC/S, WHO GBT and ICH rosters. For a correction or update, email the Chairman.
The office's own datasets, published each month as a dated snapshot you can cite in a deviation report, a submission, or a paper.
A log of every addition, flagged for what is new since you last looked — worked out in your browser, never sent. Subscribe for the monthly note, or follow by RSS.
A curated, source-cited feed of the latest regulatory moves across the 22 Arab medicines authorities — new guidelines, fee changes, GMP alerts and reliance milestones. Maintained, week to week, by the Experts' Office.
A live, automatically-updated index of the latest regulatory updates across Arab and international medicines authorities — guidances, circulars, fee changes, approvals and reliance milestones. Searchable, filterable, and refreshed every day.
A curated, illustrative register of 375 reference products across dosage forms and biosimilars — for every molecule: the form and route, the widely-recognised reference brand, and the class-appropriate way to prove equivalence (in-vivo BE, BCS biowaiver, biosimilar comparability…), with clear flags for withdrawn products that must never be used as comparators. Searchable and filterable.
Every published FDA Form 483, Warning Letter and EU non-compliance report is a free quality lesson Arab manufacturers can learn from before it happens to them. Here is the gateway to the official sources — plus the citations that recur most.
A space for the leadership of Arab pharma — the Office's technical work translated into strategy: an executive snapshot that puts your exposure and readiness in numbers, and board-ready briefs on the biggest growth-and-risk decisions.
A live, boardroom-grade decision-analysis tool: it separates a good decision from a good outcome, weighs the alternatives on their risk-adjusted value, computes what it's worth paying to resolve the uncertainty before you commit, and scores the quality of the decision itself. The methods are cited; the numbers are yours.
A business learning centre for the leaders of Arab pharma: one lesson a day across ten CEO capabilities, a decision drill you solve, then see the reasoning, a radar of the biggest global and regional conferences, and a verified shelf of courses and sources · plus a streak that grows every time you return.
A generics opportunity does not close when the patent expires. It closes months earlier, the day the filing deadline passes. This ranks the decisions still open to you by which expires first, and turns them — using your own numbers — into the monthly cost of hesitating. The regulatory evidence sits under every row, for the people who will verify it.
Your revenue is locked in local currency by tenders and price caps; your costs arrive in dollars. Enter your products, replay Egypt's documented devaluations or resample your currency's own history, and see which margin inverts first — and which repricing file to escalate today.
Type the headline claims of any management proposal and get the arithmetic tensions, the flip-points, and the chair's question list, in English and Arabic. Confidential by construction: everything computes locally and nothing is sent — the one window no chatbot can serve.
Seal every decision the day it is taken: the choice, the reasoning, the dissent annex, and the numbers as they were — with a hash computed in your browser, so any later edit is detectable. A review date turns course-correction into a calendar appointment, not an embarrassment.
The 10% preference, the verbatim adjustment equation, the 60/40 weighting formula, the award band and the penalty ceilings — read from the official Regulations and turned into calculators on your own numbers: what to bid, whether local content carries you, and what over-promising costs.
لوحة المعلومات الحيّة لتفتيش الـ GMP
An interactive, real-time platform that digitises the GMP inspection workflow — observation capture, classification, and CAPA tracking against PIC/S PE 009.
الدليل العربي للممارسات التصنيعية الجيدة 2026
Consolidated Master Edition harmonised with EU GMP · PIC/S · US FDA · WHO · ICH. Open for public consultation.
سجل مصنّعي الأدوية في الوطن العربي
A verified, bilingual master register of pharmaceutical manufacturers across the 22 Arab states — three-tier verification, a live coverage & status dashboard, and manufacturing-capability intelligence that filters makers by sterile, biologics, oncology and more.
بنك بيانات الخامات الفعّالة والسواغات
A bilingual reference bank of 363 pharmaceutical raw materials — every active and excipient mapped to its class, sourcing origin and shipping route, single-source risk, and indicative price & lead-time bands. Browse it, or pull any material straight into the Supply Resilience Studio.
Proprietary, bilingual instruments built on AUPAM's verified regulatory knowledge base — from GMP readiness and product stability in the region's climate to pan-Arab registration, Halal-pharma compliance and supply-chain resilience.
Proprietary tools · © AUPAM Experts' Office · Licensed access — not for download or redistribution
Know when your line stops before it does — a 90-day Monte-Carlo reliability model with plant-location and chokepoint exposure.
Open the studio → NewDesign your Zone IV stability studies, compute Mean Kinetic Temperature, and judge whether a heat excursion hurt your batch — against ICH, WHO and USP.
Design the study → NewClassify a device across EU MDR, US FDA & SFDA at once, register it across the 22 Arab markets, and map its route & standards.
Classify a device → NewAudit your data-integrity gaps with the questions inspectors actually ask, and study the failures that really get cited in warning letters.
Run the gap audit → NewVerify a pack through each market's track-and-trace system, triage the red flags, and know exactly what to do when you suspect one.
Verify a pack → NewWalk the OOS investigation, see which validation tests ICH Q2 requires, compute impurity thresholds (Q3A/Q3B), and check system suitability & potency.
Walk an OOS → NewDo you still owe the efficacy study? It computes the biosimilar package from your molecule, ranks your critical attributes, builds the extrapolation case — plus a bank of 31 reference biologics and the 22 traps.
Plan my package → NewDo you even need a BE study? An ICH M9 engine computes the class and the verdict, plus a molecule bank and why studies fail.
Compute my class → NewFind the right legal basis for your value-added medicine or fixed-dose combination, test whether the combination justifies itself, and see the evidence burden.
Find the legal basis →Instant registration requirements & reliance pathways across the 22 Arab markets.
Check a market → LiveFull company-wide pre-inspection self-audit against PIC/S PE 009, with a formal gap report.
Score my readiness → NewExcipient screening & Halal-readiness scoring against the OIC/SMIIC 50 standard.
Screen an excipient → NewSupply-chain risk scoring & a live feed of regional pharma disruption signals.
Watch the feed →Never miss a renewal or variation deadline — track them across the Arab markets in one place.
Open the tracker →Not sure which tool? Browse 26 real problems and what solves them →
Pick a product type and target market to get an instant requirements matrix, the current reliance pathway (who accepts whose approval), and an indicative timeline — with citations. Grounded in AUPAM's verified knowledge base.
AUPAM knowledge base for guidance — always confirm the authority's official requirements before submission.
Log your product registrations across markets and get a live countdown to every renewal — kept privately in your browser only.
Saved locally in your browser only — nothing is sent. For multi-user, org-wide tracking, ask about RegPath Professional.
Screen excipients and ingredients for their Halal status, and score your site's readiness against the OIC/SMIIC 50 standard — the on-ramp to an AUPAM Halal-GMP certification.
Guidance only — Halal status is source-dependent and requires a certificate from an accredited body. Not a substitute for certification by a competent Halal board.
Score your exposure to supply-chain risk — single-source APIs, cold-chain, transit routes, buffer stock — and track a live feed of regional pharma disruption signals.
An indicative index from your answers and public signals — for planning; not a substitute for enterprise risk analysis.
Turn your production plan into a time-phased forecast of API & excipient shortages across every product you make: it computes your real capacity (volume & time, per month and per year), explodes the plan into each material's requirement, and shows exactly when each runs out and when you must order — distilled into one Supply-Resilience Index. Runs entirely in your browser — nothing saved, nothing sent. The demo below is illustrative — stress-test it live, then run it on your own portfolio with AUPAM.
The most valuable question in biosimilar development right now: do you still owe a comparative efficacy study, and a switching study for interchangeability? The answer differs by authority and is moving in all of them. This studio is for people who already do this work — it computes the development package from your own molecule, your own analytical position and your own filing footprint. An evidence-package planner decides where the efficacy study can be avoided; an analytical-similarity console ranks your critical attributes by the risk-based discipline (not the FDA statistical tiers, which were withdrawn in 2018); a comparator-and-bridging strategist; an extrapolation builder that drafts the justification a regulator will actually read; a comparability-after-change assessor under ICH Q5E; a data bank of 31 reference biologics; and a bank of the 22 traps qualified people fall into. A peptide-frontier bench settles the question that comes before all of them: at 40 amino acids or fewer your molecule is a drug and its copy is a generic, above that it is a biologic and its copy is a biosimilar, and FDA's revised draft peptide guidances of 28 July 2026 have just loaded the generic application with biologic-grade analytics. Every moving constant carries its live status, because the expensive mistakes in this field are citation mistakes. It runs entirely in your browser — nothing is saved, nothing is sent.
The Arab world spans the full climatic range — from Mediterranean Zone II to the hot-humid Zone IV that governs most of its markets (the Gulf, Egypt, Jordan and Sudan are Zone IVa: 30 °C, 65% humidity). A product proven in Europe can quietly drift here. This studio answers the three questions every regional QA and RA lead actually has: which studies must I run for my markets, is my warehouse hotter than my label's storage claim, and how long will my product really last? It runs entirely in your browser, on your own numbers, using published constants from ICH and WHO. Nothing is saved, nothing is sent.
A medical device runs on a separate track from a medicine, and it is classified differently under the EU MDR, the US FDA and the Gulf's SFDA — then every Arab market registers it separately, because there is no single Gulf device registration. This studio answers six questions — what class is my device in all three frameworks, how do I register it in each Arab market, what is my route to market, which standards apply, how do I fix the problems that actually sink a file (testing, technical file, UDI, QMS, manufacturing, packaging, export), and how do I handle the borderline cases — plus a searchable catalog of 179 common device types, each pre-classified across the three frameworks. The EU and Gulf classes are computed from the published rules (MDR/IVDR, SFDA MDS-G008) and cited; the FDA class is estimated, because it is assigned per product code. It runs entirely in your browser — nothing is saved, nothing is sent.
Data integrity is among the most-cited findings in GMP inspections worldwide. Because experts already know ALCOA+, this studio does not explain the principles — it gives you four working things instead: a gap audit built from the questions an inspector actually asks, ranked by severity; a bank of 23 failure patterns documented in real FDA warning letters, each with its root cause and remediation; the audit-trail review programme most sites get wrong; and 21 CFR Part 11 against EU GMP Annex 11 side by side, plus the move from CSV to CSA. Definitions come from MHRA, WHO, PIC/S and FDA; the controls from Part 11 and Annex 11, the only two that are legally binding. It runs entirely in your browser — nothing is saved, nothing is sent.
Let us be honest: no browser and no software can detect a falsified product — only laboratory analysis and the marketing authorisation holder can confirm one. So this studio does the four things a professional actually needs instead: how to verify a pack in each Arab market through its track-and-trace system and identifier; a weighted triage of the red flags you observed, which tells you what they warrant rather than pronouncing a verdict; the response pathway with its real timings once you suspect; and a bank of documented falsification cases from WHO Medical Product Alerts. We keep WHO's terminology: "falsified" is a public-health concept, "counterfeit" is an intellectual-property one, and a substandard product is not a falsified one. It runs entirely in your browser — nothing is saved, nothing is sent.
What sinks a lab in an inspection is rarely a broken instrument — it is a poor out-of-specification investigation, or a test repeated until it passes. This studio gathers what a QC specialist needs day to day: the two-phase OOS/OOT investigation path the way the FDA wants it (and what is expressly prohibited), the ICH Q2(R2) method-validation characteristics by test type, an impurity-threshold calculator from the maximum daily dose (ICH Q3A/Q3B), USP <621> system suitability and the adjustments you may make to a chromatographic method without revalidating, and relative potency and parallelism for bioassays. Every number is taken from its primary source and cited. It runs entirely in your browser — nothing is saved, nothing is sent.
The most expensive question in a generic dossier: do I have to run a bioequivalence study, or can I earn a biowaiver? This studio computes the answer from ICH M9's actual rules rather than describing them — describe solubility, permeability, dissolution speed and excipients, and it returns the BCS class, the verdict, and the exact criterion that decided it. The distinction most teams transpose: Class I needs rapid dissolution (85% in 30 minutes), while Class III needs very rapid (85% in 15 minutes) plus stricter excipient matching. Then the other waivers (additional strengths, f2), study design and acceptance criteria with EMA and FDA kept apart where they genuinely differ on highly variable drugs, a molecule bank of BCS classes and biowaiver prospects, and a bank of why studies fail — including the CRO episodes where bioequivalence data was rejected wholesale. A molecule's BCS class is not a regulatory fact: sources differ and the authority decides on your data. It runs entirely in your browser — nothing is saved, nothing is sent.
The first thing many teams get wrong: "value-added medicine" is an industry term, not a legal category — there is no application type of that name in EU or US law. Every value-added product or fixed-dose combination is filed under an existing legal basis: most often EU Article 10(3) hybrid or Article 10b fixed combination, or US 505(b)(2). Choosing that basis wrongly is what sinks the dossier, so the studio starts there. Describe what you are actually changing and it maps you to the article and the data it demands; then test whether the combination justifies itself against the questions an assessor asks (each component's contribution, the dose ratio, PK compatibility, titration, adherence); then the evidence burden of bioequivalence and biowaivers; then real archetypes of value-added and combination products and the pathway each used. Values are drawn from primary sources (Directive 2001/83/EC, WHO TRS 929, 21 CFR 300.50) and cited. It runs entirely in your browser — nothing is saved, nothing is sent.
A bilingual reference bank of 363 pharmaceutical raw materials — actives and excipients — each mapped to its therapeutic or functional class, dominant sourcing origin and shipping route, single-source risk, indicative price and lead-time bands, and compendial status. Browse it here, or pull any material straight into the Supply Resilience Studio to model your own plant.
Open it from a USB stick in a plant with no network and it works in full: 265 inspection points across 27 GMP systems, documented classification, corrective actions tracked to closure, photographic evidence, and reports ready to sign — in English and Arabic. Nothing you type ever leaves the machine you typed it on.
A 59-scene guided tour is built into the dashboard itself · 23:16 in English, 31:02 in Arabic; the newest scene is captioned and awaits its narration.
Every point carries its requirement in both languages and the clauses it rests on — EU GMP and its annexes, PIC/S, WHO, ICH and 21 CFR. Mark each one conforming, deficient or not applicable, and record what you saw.
When the closing meeting ends, both parties sign on screen and a digest is fixed over everything recorded. Months later anyone can reopen the same file and recompute it offline: if anything moved after the signatures, it names the point, the person and the time.
The same inspection written in the structure the reader expects: an EU/PIC S layout, a WHO-style layout, an Arabic-first bilingual layout, plus the FDA-style 483 and EIR. Layouts only — not official forms of any authority.
The classification assistant walks the PIC/S PI 040 decision path in order and writes the answers into the finding itself. The report then shows why a deficiency is critical rather than asserting it — which is what makes three inspectors reach the same call.
It compares your severity mix with inspection data a regulator published — 258 inspections and over 5,000 deficiencies. If your critical rate is a multiple of the reference, you learn it before the closing meeting rather than after. The panel also says plainly where no published reference exists at all.
The dashboard runs its own installation and operational qualification — 23 documented test cases, each with an acceptance criterion, printed as a protocol you sign and file. It states its position on 21 CFR Part 11 and EU Annex 11 requirement by requirement: what it meets, what it shares with you, and the one thing it cannot meet without a server. We do not claim it is validated in your process. Validation is shared; we supply the evidence that makes concluding it cheap.
Inspection teams split up. Each inspector works their own copy offline, exports a contribution pack, and the lead merges them. Where two people assessed the same point differently, nothing is overwritten — the conflict is shown side by side and a human decides.
A signer enrols with a unique identifier that is never reused and a private passphrase that is never stored. Both are demanded at every signing, and the signature is bound to the record content and the credential together, so it cannot be moved onto another record. The tool prints its position requirement by requirement, and what it does not meet is written in red.
An optional lock, off by default, encrypts the record before it reaches storage. The plaintext leaves the device, so opening the file is no longer enough to read the inspection. The passphrase is never stored: forget it and the record is gone, recoverable by nobody, and that is the property that makes the lock worth having. The tool also states plainly what it is not: it is not AES, and it does not cover photographs.
All 164 interview questions now carry an expected answer: what a compliant site says and shows, three or four things you must hear or see with one marked as the must-have, what a weak answer sounds like, what to ask to see, and one line of coaching for a first inspection. You do not type a verdict; you tick what you actually heard, and the verdict follows, so two inspectors with the same ticks reach the same answer. The whole interview record folds into the seal and prints as its own document.
The dashboard runs entirely inside your browser — no account, no server, no upload. Inspection records stay on your own device, and you decide what is exported and when. Access is for subscribers and is granted by the Chairman.
Clause 2.4 asks the harder question: taken together, are these controls effective? Most contamination control dashboards answer it with a wall of green tiles, each true on its own. This one takes fourteen routes by which contamination could reach the product, asks what barriers stand on each, and then tells you where the strategy has no real depth and where it would never know it had been breached.
Try it without a passcode: the verified Annex 1 tables, the sources panel and one full contamination route are open to anyone.
From operator microflora to open product, from biofilm in a water loop to a contact surface, from a glove breach on the isolator straight into the critical zone. Each route carries its barriers, and each barrier its kind: engineered, procedural, detective or corrective. Score what you actually have, and the route resting on a single control shows itself.
This is what separates the tool from a checklist. Three procedures resting on the same training system are not three layers, they are one, because they all fail the day that system does. Barriers are grouped by common cause and only the strongest in each group counts, and a good deal of apparent depth evaporates the moment you look at it that way.
A route with four preventive layers and no effective detective control is an unprotected route however deep it looks, because if it were breached nothing would tell you. The tool names such routes and will not let depth buy silence about them. It is the first thing a competent inspector looks for and the last thing a tile dashboard shows.
Annex 1 carries two tables for qualification and two for routine monitoring, and the values differ between them. The grade A limit at 5 µm is 29 per cubic metre when monitoring and is not specified at all for classification. Anyone printing one flat number is wrong in one of the two cases. Pick the stage you are working in and the tool shows only the table that applies, with its clause.
The grade A viable limit is not less than one colony, it is No growth, and any growth triggers an investigation. The three media fill tiers are not in Annex 1 at all but in FDA guidance from 2004, and they are more permissive than clause 9.46. The air speed figure is a guidance value at the working position, not a hard specification. And Annex 1 (2022) contains no mapping between grades and ISO classes. Each error is shown beside what is actually written, and where that comes from.
We built it the usual way first: a breach probability per barrier, multiplied together. It rated a strategy whose six barriers were every one of them weak at ninety nine per cent protected. That is not a rounding problem, it is the wrong shape of answer, because it lets six feeble controls outscore two good ones. So it was thrown away. The tool counts effective layers instead of multiplying probabilities, and gives each route a plain verdict: unprotected, thin, adequate depth, or defence in depth.
From total organic carbon in water for injection to non condensable gases in clean steam, from the glove print to process capability. Each parameter carries its alert level, its action limit and the reference it rests on. More usefully, the tool separates what the regulation fixes from what your site sets and justifies, and inspectors probe that boundary more than any single value.
Clause 2.5 lists what a strategy should consider, and the tool carries that list as the Commission published it rather than as templates repeat it. Two widely circulated phrases come from the 2020 draft: the final text says detailed knowledge, not thorough, and it dropped the word documented. Anyone arguing that the law mandates a single document is quoting a superseded draft.
Clause 2.6 asks for the impact of every change to be assessed before implementation and again after. The second assessment is the one sites skip, so the tool counts it on its own and names the changes still waiting for it. Record a review and today's barrier scores become a baseline; at the next review the tool lists every score that moved and which way it went. On the interval itself the tool refuses to invent a number. Annex 1 sets none, so the cadence is yours and your strategy has to justify it.
A barrier score is judgement. A media fill result is not. The tool reads what you entered elsewhere, the contaminated units, the control-chart signals, the requalification dates, the disinfectant efficacy figure, and names every place where a score claims more than your own records support. A control marked strong and verified while the indicator behind it sits at eighty per cent is what an inspector finds in ten minutes.
No account, no server, no upload. Your barrier scores are a map of the weakest points in your plant, and that is the last thing that should leave your machine. Everything stays with you, you export what you choose when you choose, and the sources panel lists what was checked and rejected as well as what was used.
The verified Annex 1 tables, the sources panel and one full contamination route work for anyone, so you can judge the tool before asking for anything. Open route R01, score its barriers, and watch the verdict change. The other thirteen routes and the remaining modules are for subscribers.
Every constant in the tool was checked against its primary text, and where no published reference exists the tool says so. The sources panel lists what was checked and rejected, not only what was used.
A free, structured self-assessment across 20 chapters mapped to PIC/S PE 009 (and its annexes). Score your readiness, see your gaps chapter by chapter — then run the full pre-inspection audit on the GMP Live-Inspection Dashboard.
A practical bank of the recurring problems Arab pharma teams hit across the product lifecycle — from sourcing a discontinued reference product, to alternative API sources, dossier deficiencies and data integrity. Each entry gives the cause, the step-by-step fix, where to source the data, and the standard it maps to.
Market intelligence, the promotional-compliance rules that keep pharma marketing legal, digital & analytics tools, channels to reach doctors and patients, design — plus AUPAM's own reach. The toolkit every marketing lead keeps one click away.
A curated hub of the strongest data sources for master's and PhD candidates in pharmaceutical sciences — AI literature search across Consensus, hand-picked evidence, and a directory of molecular/drug databases, clinical trials, pharmacopoeial sources, bioequivalence & PK data, and statistics tools — mostly free — plus AUPAM's own Arab-market datasets.
Every dataset here states its edition, its compile date and its record counts — measured from the live data, never typed. This section is for the people who put that to work: researchers, faculty and graduate students. Copy citations as plain text, BibTeX or RIS, and take the crawlable dataset pages for your library.
Accredited courses and workshops run by the Experts' Office — GMP, regulatory affairs, data integrity and more. Pick a session and register your seat directly.
Tap any series to browse its past editions or publish a new one. اضغط أي سلسلة لتصفّح أعدادها السابقة أو إضافة عدد جديد.
"Where the guidance runs out, the decision begins."
Latest · 1 edition · الممارسات الجيّدة عند حدود الإرشادات
Osama Abd Elrahman, Nadia Rashed Al Mazrouei, Abeer M. Al-Ghananeem, Hakimah Hoseh
Osama Abd Elrahman, Abeer M. Al-Ghananeem, Abdulnaser Sijari, Hakimah Hoseh
Specialist forums across every field of the pharmaceutical industry — from GMP and regulatory affairs to pharmacovigilance and supply chain. Ask a question, share expertise, and connect with peers across the region.
You'd be joining the technical arm of the Arab manufacturers' union — the single technical reference for GMP, registration and supply across all 22 Arab markets. Below are the steps and conditions for new working experts, reviewed monthly by the Scientific Committee.
أنت تنضمّ إلى الذراع التقنية لاتحاد المصنّعين العرب · المرجع التقني الواحد للـ GMP والتسجيل والتوريد عبر أسواق الوطن العربي الاثنين والعشرين. وفيما يلي خطوات وشروط انضمام الأعضاء العاملين الجدد، وتراجعها اللجنة العلمية شهريًا.
In pharmacy, medicine, dentistry, veterinary medicine, science (biology, microbiology or chemistry) or engineering (civil, mechanical or chemical) from a recognised university. Priority to holders of MSc & PhD degrees.
A minimum of 15 years across the different fields of pharmaceutical work — in Arab medicines authorities or in drug & medical-device manufacturing companies.
Including a copy of national ID in the applicant's country, copies of the required certificates, a CV, and a named reference.
Submitted in the name of the Chairman of the Experts' Office and signed by the new membership applicant.
Completed applications are studied by the Scientific Committee to define the precise specialty required, then referred to the Board to accept or decline.
The new working member pays a nominal annual subscription fee of USD 100.
New members are drawn from different Arab countries so most are represented, with no more than two members per distinct pharmaceutical specialty.
The Scientific Committee convenes every month to evaluate and study applications.
The Chairman reports new member admissions to the President of the Board of the Arab Union of the Manufacturers of Pharmaceuticals and Medical Appliances.
As the manufacturers' own technical arm, we work with authorities, industry and universities across the MENA region — one technical reference across all 22 Arab markets.
الجهات التنظيمية
الصناعة الدوائية
الجامعات
نحو منظومة دوائية عربية موحّدة وموثوقة.
o.abdelrahman@aupam.orgThe technical arm of the Arab Union of the Manufacturers of Pharmaceuticals and Medical Appliances · established 1986.
Chairman · Associate Prof. Dr. rer. nat. Osama Abd Elrahman
Reviewed monthly by the Scientific Committee · مراجعة شهرية. Fields marked * are required.
Thank you — your application has been received by the AUPAM Experts' Office and will be reviewed by the Scientific Committee. We'll get back to you by email once the review is complete.
Sign in to add, edit, and delete editions for everyone.
Thank you — we'll email you the joining details shortly. شكرًا لك · سنرسل لك تفاصيل الحضور قريبًا.
Thank you — the Experts' Office will be in touch shortly. شكرًا لك · سيتواصل معك مكتب الخبراء قريبًا.
