GMP in Pharmaceutical Laboratories
Apply GMP in the pharmaceutical QC laboratory. Participants review regulatory requirements for development, release and stability testing, method validation, equipment qualification, data integrity and OOS/OOT investigations, and compare GMP with GLP expectations.
At a glance
- 2 days
Who it's for
- Lab technical staff, supervisors and managers;
- QA supporting labs; managers of outsourced lab work
Learning objectives
- Apply GMP expectations to analysis of pharmaceutical, biopharmaceutical and biological samples
- Understand regulatory framework for development, release and stability testing
- Compare GMP lab requirements with GLP
Detailed content
- EU GMP Chapter 6 and 21 CFR 211 Subpart I
- WHO and EDA expectations
- GMP vs GLP
- Analytical method validation (ICH Q2) and transfer
- Equipment qualification (DQ, IQ, OQ, PQ)
- Reference standards and reagents
- ALCOA+ principles
- Audit trails and computerised systems
- Good documentation practice in the lab
- OOS and OOT investigation phases
- Laboratory error vs process failure
- CAPA from lab investigations
- Release and stability testing
- Investigational vs commercial products
- Managing contract laboratories
Day-by-day agenda
A typical schedule. In-company versions are tailored to your processes, data and timing.
- Regulatory framework
- Methods and equipment
- Data integrity
- Investigations
- Testing and outsourcing
- Case study, action plans and course assessment
Practice, tools and assessment
Hands-on practice
- Build a HACCP plan for one product: flow diagram, hazards, CCPs, limits
- PRP/GMP inspection walk with nonconformity reporting
- Traceability and mock-recall exercise
- Mock regulatory inspection of a GMP area
Tools and templates you keep
- HACCP plan worksheets (hazard analysis, CCP decision tree)
- PRP/GMP inspection checklist
- Mock-recall record
- Deviation, CAPA and change-control forms
How learning is assessed
- Pre- and post-course knowledge check
- Assessment of practical exercises by the trainer
- Action plan reviewed at the end of the course
Built on these standards and bodies of knowledge
- Codex Alimentarius CXC 1-1969 (General Principles of Food Hygiene, 2022)
- ISO 22000:2018 and FSSC 22000 v6
- BRCGS Food Safety Issue 9 / IFS Food 8
How it is delivered
- Public courses in Cairo, in-company programs and live online training
- Practical exercises, case studies and examples from your sector
- Can also run as Train & Stay in Sharm El Sheikh, Hurghada or Cairo
Part of these career paths
- Pharma, Medical Devices & Food Safety · Practitioner
Frequently asked questions
How long is GMP in Pharmaceutical Laboratories?
The program runs 2 days. In-company versions can be adapted to your needs.
Is the course taught in Arabic or English?
Sessions are usually delivered in Arabic with English technical terms and materials. Full English delivery is available for in-company groups.
Can you run it inside our company?
Yes. In-company programs use exercises built on your own processes. Tell us the group size and preferred timing and we will send a proposal.
Will I receive a certificate?
Participants who complete the program and its assessment receive a certificate from The Excellence Center, which can be verified online.
More programs in this field
- HACCP and Food Safety Risk Analysis
- ASQ CPGP – Certified Pharmaceutical GMP Professional (Exam Preparation)15 days
- GMP Auditor Training for Quality Systems2 days
- GMP for Medical Devices (ISO 13485)2 days
- GMP for Pharmaceutical Facilities, Equipment & Utilities3 days
- Good Laboratory & Good Manufacturing Practices (GLP + GMP) Workshop5 days
- Good Manufacturing Practices (GMP) for the Pharmaceutical Industry5 days
- Pharmaceutical Clean Rooms & HVAC: Design, Qualification and Monitoring4 days
- Pharmaceutical Water Systems: Principles & Practice2 days
Get dates, fees and the full outline.
Tell us whether you are joining as an individual or planning a program for your team.