Industry 11
Pharmaceutical manufacturing: GMP, qualification and validation
In medicines, quality is not only checked, it has to be demonstrated. We help sites document, qualify and validate without slowing production.
Pharmaceutical plants must comply with Good Manufacturing Practice (GMP) and be able to prove it at inspection. That covers premises, utilities (purified water, compressed air, HVAC), equipment, processes and people.
Our experience of controlled environments and industrial maintenance lets us work on qualification, validation and equipment reliability.
Key process steps
- 01
Receiving and dispensing
Raw material checks, dispensing booth under laminar flow.
- 02
Granulation and blending
Wet or dry granulation, drying, sizing, blending.
- 03
Compression or filling
Tablet presses, capsules, liquids and semi-solids.
- 04
Coating
Tablet film coating, control of appearance and dissolution.
- 05
Primary and secondary packing
Blistering, bottling, cartons, serialisation.
- 06
Testing and release
In-process and release testing, batch record review.
The challenges we see
- Inspection findings and action plans to close
- Qualification and requalification of equipment and cleanrooms
- Cleaning validation and cross-contamination control
- Reliability of critical utilities (HVAC, purified water)
How we help
- GMP gap assessment and inspection readiness
- Qualification plans and protocols (IQ, OQ, PQ)
- Process and cleaning validation
- Maintenance of critical utilities and production equipment
- Staff training in GMP and cleanroom hygiene
Standards and frameworks
- Moroccan GMP
- EU GMP
- ICH Q7, Q8, Q9, Q10
- ISO 14644 (cleanrooms)
A project in this industry?
The first consultation is free. Tell us about your plant or project and we will get back to you within 48 hours.