International Professional Credential
Professional Credential in Good Manufacturing Practices for Pharmaceutical Manufacturing
This credential assesses professional competence in understanding and applying Good Manufacturing Practices within pharmaceutical manufacturing environments. It supports professionals in production, quality, laboratories, packaging, and supply operations who need verified competence in documentation, process control, and quality-risk management.
GMP-PHARMProfessional certificationValidity: 36 months
Defined competencePublished scope and outcomes
Independent assessmentExamination and case study
Public verificationStatus can be checked
Renewal cycle36 months
0Credential holders
Fees and costs
This page displays the current standard fees for this credential.
Displayed fees are standard credential fees. The final total may vary by appointment, country, centre, or delivery mode and is locked in the invoice before payment. Partner and coupon discounts are applied only after validation and are not publicly displayed.
Refund and cancellation policy
Fees, refunds, and cancellations are governed by the selected credential and appointment rules. Fees are not automatically refundable after an examination starts or for an unexcused no-show.
What is this certification?
This is an individual professional competence credential in Good Manufacturing Practices for pharmaceutical manufacturing. It assesses knowledge and practical application of pharmaceutical quality-system principles, including documentation, process control, deviation management, CAPA, and change control.
It is not a GMP certificate for a manufacturing site, a license to manufacture or market medicines, or a substitute for regulatory inspection and approval.
Why it matters
GMP helps reduce quality risks that final-product testing alone cannot reliably prevent or detect.
The credential supports a consistent understanding of documented work practices, product protection, and prevention of mix-ups, contamination, manufacturing errors, packaging errors, and unreliable records.
Also known as: Pharmaceutical GMP Credential, GMP Quality Practice Credential, Pharmaceutical Manufacturing GMP Certificate, Pharmaceutical Quality System Credential
Quick takeaways
- An individual competence credential, not a factory certification
- Designed for pharmaceutical manufacturing environments
- Focused on practical application of pharmaceutical quality systems
- Covers documentation, deviations, CAPA, and change control
- Supports employability and professional development in the pharmaceutical industry
Who is it for and what does it support?
Suitable for
- Pharmaceutical manufacturing personnel
- Quality assurance and quality control professionals
- Packaging, warehousing, and supply-chain personnel
- Laboratory, validation, qualification, and process-support professionals
- Recent graduates and professionals entering the pharmaceutical industry
- Supervisors and team leaders who need a shared understanding of pharmaceutical quality systems
Professional value
- Verified professional competence in pharmaceutical GMP
- Improved readiness for production, quality, packaging, and laboratory roles
- Support for progression into QA, compliance, and quality-system responsibilities
- Stronger ability to contribute to investigations, deviations, CAPA, and change control
- A credible addition to a professional profile for pharmaceutical manufacturers and service providers
Practice and career relevance
The credential connects GMP principles to day-to-day manufacturing decisions: how work is documented, when a deviation is raised, how impact is assessed, when CAPA or change control is needed, and how inspection readiness is supported.
It is relevant to career pathways in pharmaceutical production, QA, QC, packaging, warehousing, validation, qualification, and regulatory compliance.
This may not be the right fit when
- If you are seeking GMP certification for a factory or manufacturing site
- If you need a legal license to practise a profession or manufacture medicines
- If your work is limited to food, cosmetics, or medical devices and requires a sector-specific GMP programme
- If you only need introductory awareness training without a professional competence assessment
Competencies and knowledge framework
GMP-QMSPharmaceutical Quality Management System
Explains quality system elements and documents deviations and CAPA.
GMP-DOCDocumentation & Data Integrity
Applies ALCOA+ principles and record management.
GMP-PROCProduction Operations & Process Controls
Follows operating instructions, escalates deviations and applies change control.
GMP-FACFacilities, Equipment & Qualification
Understands qualification, maintenance, calibration and contamination control.
GMP-QCQuality Control & Sampling
Understands sampling plans and management of out-of-specification results.
GMP-RISKQuality Risk Management & Improvement
Uses risk assessment, root-cause investigation and improvement.
GMP-ETHICSEthics & Professional Accountability
Acts with integrity when managing data, deviations and operational pressures.
Knowledge domains
20%
Quality System & Risk Management
Quality system, risk management, CAPA and change control.
15%
Documentation & Data Integrity
Records, good documentation practices and data integrity.
15%
Facilities, Equipment & Qualification
Qualification, calibration, maintenance and contamination control.
20%
Production & Process Controls
Operating instructions, batch records and deviations.
15%
Quality Control & Laboratories
Sampling, testing and out-of-specification results.
8%
Suppliers, Storage & Distribution
Supplier qualification, storage, complaints and recalls.
7%
Professionalism & Accountability
Professionalism, escalation, integrity and accountability.
How competence is assessed
Assessment method
Examination and case study
Examination format
80 questions · 120 minutes
Passing standard
70%
Practical evidence
Case study or practical evidence required
Training completion alone does not confer this credential. Award requires eligibility, assessment and an independent certification decision.
Eligibility, validity and renewal
Eligibility
Relevant qualification or documented practical experience in a regulated manufacturing or related pharmaceutical/health sector environment.
Credential validity
36 months
Renewal requirements
20 CPD hours / 20 credits
Scope notice: This credential does not grant a license to manufacture, release, inspect, approve, or regulate pharmaceutical products and does not replace applicable local regulatory requirements.
Context tracks
GENERALGeneral Pharmaceutical GMP Context
General Pharmaceutical GMP Context
PHARMA-MFGNon-Sterile Pharmaceutical Manufacturing
Applies GMP requirements to non-sterile dosage-form manufacturing such as tablets, capsules, syrups, and topical products, with emphasis on process control, prevention of mix-ups and contamination, and operational documentation.
STERILESterile Manufacturing and Aseptic Processing
Focuses on sterile production environments, personnel practices, clean areas, microbiological contamination control, media simulation, and critical-process control.
APIActive Pharmaceutical Ingredient Manufacturing
Applies GMP principles to API manufacturing, including material and process control, impurities, cleaning, traceability, and management of chemical or biological production stages.
BIOPHARMABiopharmaceutical Manufacturing
Focuses on biologic and biopharmaceutical products, including biological material control, cell culture, cross-contamination, storage conditions, and batch traceability.
PACKAGINGPharmaceutical Packaging and Labeling
Focuses on primary and secondary packaging, label verification, line clearance, reconciliation, mix-up prevention, and control of printed materials.
QC-LABPharmaceutical Quality Control Laboratories
Applies GMP to quality-control laboratories, including sample management, data integrity, out-of-specification results, equipment, records, and laboratory investigations.
QA-QSPharmaceutical Quality Assurance and Quality Systems
Focuses on the pharmaceutical quality system, record review, deviations, CAPA, change control, internal audits, and compliance oversight.
VALIDATIONPharmaceutical Qualification and Validation
Focuses on qualification of facilities, equipment, and systems; validation of processes, cleaning, and analytical methods; and management of the validated state across the product lifecycle.
DATA-INTEGRITYData Integrity and Computerized Systems
Focuses on ALCOA+ principles, electronic records, access control, audit review, backup, and integrity of manufacturing and quality data.
WAREHOUSEPharmaceutical Warehousing and Supply Chain
Focuses on material receipt, quarantine, storage, temperature control, distribution, traceability, and management of returned or nonconforming materials.
Examination guide and booking
The GMP Quality Practice Credential assessment has two required components:
1. **GMP Knowledge Examination**
A computer-based examination of 80 single-best-answer multiple-choice questions, including applied GMP scenarios.
Duration: 120 minutes.
Pass mark: 70%.
The examination is structured across three sections:
* Pharmaceutical quality systems, risk management, documentation, and data integrity: 28 questions.
* Facilities, equipment, qualification, production, and process controls: 28 questions.
* Quality control laboratories, suppliers, storage, distribution, professionalism, and accountability: 24 questions.
2. **Applied Case Study**
Candidates analyse a practical GMP scenario and demonstrate appropriate containment, documentation, escalation, risk assessment, and proposed actions.
The case study is assessed against a published rubric by two independent assessors.
Pass mark for the case study: 70%.
Candidates must pass both components to be awarded the credential. Passing one component alone does not result in a partial credential.
Candidates must arrive 30 minutes before an in-person examination or join 20 minutes before a remotely proctored examination. Mobile phones, notes, books, headphones, AI tools, and unauthorised assistance are prohibited.
1. **GMP Knowledge Examination**
A computer-based examination of 80 single-best-answer multiple-choice questions, including applied GMP scenarios.
Duration: 120 minutes.
Pass mark: 70%.
The examination is structured across three sections:
* Pharmaceutical quality systems, risk management, documentation, and data integrity: 28 questions.
* Facilities, equipment, qualification, production, and process controls: 28 questions.
* Quality control laboratories, suppliers, storage, distribution, professionalism, and accountability: 24 questions.
2. **Applied Case Study**
Candidates analyse a practical GMP scenario and demonstrate appropriate containment, documentation, escalation, risk assessment, and proposed actions.
The case study is assessed against a published rubric by two independent assessors.
Pass mark for the case study: 70%.
Candidates must pass both components to be awarded the credential. Passing one component alone does not result in a partial credential.
Candidates must arrive 30 minutes before an in-person examination or join 20 minutes before a remotely proctored examination. Mobile phones, notes, books, headphones, AI tools, and unauthorised assistance are prohibited.
in_person, remote_proctoredDelivery modes
1Level examination plans
3Assessment components
0Available appointments
Examination format by level
| Level | Questions | Duration | Pass mark |
|---|---|---|---|
| GMP Quality Practice Credential | 80 | 120 min | 70% |
Assessment components
GMP-P-EXAMGMP Knowledge Examination
Knowledge examination
GMP-P-CASEApplied Case Study
case
PRIMARY-EXAM_CASEPrimary assessment
Examination and case study
Candidate information
Booking
Booking becomes available after eligibility approval and confirmation of registration requirements. Candidates select an available date, delivery mode, and examination location through the candidate portal.
One reschedule is permitted without charge when requested at least seven calendar days before the appointment. Late changes or no-shows without documented exceptional circumstances are subject to administrative review and may require a new booking fee.
One reschedule is permitted without charge when requested at least seven calendar days before the appointment. Late changes or no-shows without documented exceptional circumstances are subject to administrative review and may require a new booking fee.
Identity requirements
Candidates must present an original, valid government-issued photo ID. The name on the ID must match the application and booking record.
For remotely proctored examinations, candidates must present their ID to the camera, complete a visual check of the testing environment, and keep the camera and microphone active throughout the session in accordance with the applicable privacy and proctoring policy.
For remotely proctored examinations, candidates must present their ID to the camera, complete a visual check of the testing environment, and keep the camera and microphone active throughout the session in accordance with the applicable privacy and proctoring policy.
Accommodations
Candidates with disabilities or special needs may request reasonable accommodations at least 14 calendar days before the examination date, with supporting documentation where appropriate.
Accommodations may include additional time, supervised breaks, screen-reader support, or suitable seating arrangements. Accommodations do not reduce the competence standard or alter the assessment outcomes.
Accommodations may include additional time, supervised breaks, screen-reader support, or suitable seating arrangements. Accommodations do not reduce the competence standard or alter the assessment outcomes.
Retake / resit
Candidates who do not pass an assessment component may resit after a minimum waiting period of 30 calendar days.
A maximum of three attempts is permitted within a 12-month period. Any additional attempt requires Certification Committee approval and evidence of a documented learning or professional-development plan.
A maximum of three attempts is permitted within a 12-month period. Any additional attempt requires Certification Committee approval and evidence of a documented learning or professional-development plan.
Results
Final results are issued within 10 business days after completion of all assessment components and required quality review.
Any result displayed immediately after a computer-based examination is provisional until quality checks and administrative review are complete. Final status is shown in the candidate portal as Pass, Not Passed, or Under Review.
Candidates may request an administrative review in accordance with the appeals policy within 14 calendar days of the result notification.
Any result displayed immediately after a computer-based examination is provisional until quality checks and administrative review are complete. Final status is shown in the candidate portal as Pass, Not Passed, or Under Review.
Candidates may request an administrative review in accordance with the appeals policy within 14 calendar days of the result notification.
Training providers, test centres and appointments
Approved training providers
OMDIIC-TRAININGOmdiic Egypt
القاهرة · مصر
Governance, impartiality and public trust
Training delivery, assessment and certification decisions are separated by design. Governance and policy information is published for transparency.
scientific_councilGMP Scientific Council
Reviews the credential scope, competences, scientific content, examination guide, and learning outcomes, and updates them when relevant pharmaceutical GMP requirements change.
certification_decisionCertification Decision Committee
Makes award, denial, suspension, or withdrawal decisions after confirming eligibility, assessment completion, impartiality declarations, and required review.
appealsAppeals and Complaints Committee
Independently reviews appeals and complaints separately from the original assessment and certification decision, issuing documented recommendations or decisions within published timelines.
assessment_committeeExamination and Assessment Committee
Develops the examination blueprint, reviews the item bank and case studies, defines assessment criteria, and reviews result quality without making certification decisions.
Decision independence
2 independent certification decisions are required before issuance.
The GMP-P credential is awarded only after eligibility requirements, identity verification where applicable, all assessment components, and relevant conflict-of-interest checks have been completed.
Award of the credential requires two documented independent decisions by two different Certification Decision Committee members. Neither decision-maker may have trained, assessed, reviewed eligibility for, or administered the examination of the same candidate.
The certification decision must remain separate from the decision to open applications, eligibility approval, examination scoring, and issuance of the credential record or digital certificate.
Training providers, training organisations, and examination centres have no authority to award, deny, or issue the credential. Their role is limited to training, operational support, or approved examination delivery.
The credential issuer may issue the credential only after confirming that two valid independent certification decisions are recorded, the candidate file is complete, and no open appeal or investigation affects the decision.
Appeals are reviewed by a body that did not participate in the original assessment or certification decision. All decisions, declarations, and actions must be retained in an auditable record.
Topics this credential addresses
Pharmaceutical quality systems and management responsibilitiesPersonnel training, hygiene, and good practicesPremises, utilities, equipment, contamination, and mix-up preventionDocumentation, batch records, and data integrityControl of raw materials, printed materials, and packaging componentsManufacturing, packaging, process control, and line clearanceDeviations, investigations, and impact assessmentCorrective and preventive actions (CAPA)Change control, quality risk management, and continual improvementQualification, validation, and ongoing reviewComplaints, returned products, and recallsInspection readiness and internal audits
Frequently asked questions
Is this a GMP certificate for a factory?
No. It is an individual competence credential and does not certify a manufacturing site or facility.
Does this credential authorize pharmaceutical manufacturing?
No. Manufacturing authorization and regulatory compliance are determined by competent authorities under applicable law.
Who can apply?
Professionals working in or seeking roles in pharmaceutical manufacturing, quality, laboratories, packaging, warehousing, and related functions.
What does the assessment measure?
It measures understanding of GMP principles and the ability to apply them in practical situations involving documentation, deviations, quality, and risk.
Is previous experience required?
A pharmaceutical background or professional interest is recommended; final eligibility requirements are stated on the application page.
Is it suitable for food or cosmetics?
Its primary scope is pharmaceutical manufacturing. Other sectors may require GMP programmes tailored to their regulatory requirements.
How can an employer verify the credential?
Through the official verification page using the credential number, QR code, or verification code.
شهادة GMP للمنتجات الدوائية
كفاءة مهنية في ممارسات التصنيع الجيد