GMP
Quality, Control and Traceability in Every Step
At Pharmtronica AB, our quality system is built around GMP-aligned principles for controlled pharmaceutical work. These principles guide our documentation, training, material handling, preparation processes, review steps, and traceability throughout the site.
Our current authorised activity is Magistral Manufacture under a permit granted by the Swedish Medical Products Agency, LMV. In addition, we are developing future service areas in Contract Manufacture and API-related activities. These future services will only be offered when the required regulatory, quality system, and compliance requirements are fully in place.
Why GMP-Aligned Principles Matter
Pharmaceutical work requires more than technical skill. It requires consistency, accountability, documented control, and a clear understanding of quality responsibilities. GMP-aligned principles provide a structured framework for safe handling, reliable processes, accurate documentation, and traceable decision-making.
At Pharmtronica, these principles support how we train personnel, define procedures, review work, handle materials, and maintain quality oversight across controlled activities.
What GMP means
What is GMP?
GMP stands for Good Manufacturing Practice.
In simple terms, it means working according to clear procedures, trained responsibilities, documented controls, and defined quality standards so that pharmaceutical products are suitable for their intended use.
It also covers how we manage quality documents, supplier approval, training, cleaning, environmental control, equipment maintenance, batch documentation, and product release. The aim is to protect product quality, patient safety, and ensure regulatory compliance.
GMP in our daily operations
How GMP is applied at Pharmtronica
Our site in Sollentuna operates with a structured quality management system designed to ensure that pharmaceutical products are manufactured and controlled to standards appropriate for their intended use. This includes:
- Documented procedures and work instructions.
- Product and batch-related documentation.
- Supplier and contractor qualification.
- Quality risk management.
- Deviation and change control.
- Qualification, validation, and calibration.
- Cleaning and sanitation routines.
- Environmental monitoring.
- Self-inspection and ongoing follow-up.
These elements support reliable day-to-day operations and help maintain consistency across our pharmaceutical activities.
GMP and our business areas
GMP across our business areas
Pharmtronica’s GMP-focused site supports three main business areas, and GMP is relevant across all of them.
Magistral Manufacture
For magistral preparations, GMP supports controlled handling, clear documentation, labelling control, and independent checks before final release. The Master File describes pre-inspection of the formulation and order, manufacturing and labelling control, and final inspection by a different qualified pharmacist to ensure independent verification.
Contract Manufacture
For contract manufacturing, GMP supports controlled receipt of materials, documented processing, packaging and labelling activities, batch documentation, and certification in line with the agreed quality and technical setup between Pharmtronica and the customer.
API Supply
For API-related activities, GMP supports the controlled import and handling of active substances and raw materials, including sampling, identity testing, documentation, and repackaging under defined procedures and quality arrangements.
Quality system
A quality system built for pharmaceutical control
Our quality management system is designed to support safety, quality, and compliance throughout the product lifecycle. According to the Master File, the system is structured around key documents such as the Quality Manual, Site Master File, procedures, specifications, methods of analysis, batch-related documents, and records. It also includes follow-up systems for audits, CAPA, management review, supplier approval, complaint handling, risk management, and recall-related processes.
This means that GMP at Pharmtronica is built on more than good intention. It is built on written systems, review processes, and defined responsibilities.
People and competence
Qualified people are essential to GMP
GMP depends on people as much as procedures. Pharmtronica’s organisation includes Qualified Persons, a GMP-Responsible Person, pharmacists, and QA leadership, supported by trained personnel across production and site functions. Ongoing training, clear roles, and independent review steps are part of maintaining control and quality in daily work.
Facility and control
Controlled premises and controlled processes
Pharmtronica’s site is designed to support GMP-based work through defined operational areas, equipment-specific procedures, environmental control, and cleaning routines adapted to each area. The Master File describes routine and documented cleaning, annual environmental control by an external service provider, calibration routines, qualification activities, and maintenance plans for equipment and premises.
This helps create a working environment where products, materials, and records can be handled in a controlled and traceable way.
Product release and oversight
Final review and release matter
A key part of GMP is that products are not only made under control, but also reviewed under control. The Master File states that each batch of finished product is approved or released by a designated person from Quality Assurance, confirming that the product has been manufactured and controlled according to the relevant GMP standards and product specifications.
This final oversight is an important safeguard for product quality and compliance.
Get in touch
Get in touch with Pharmtronica AB for service enquiries, partnership discussions, or further information about our operations.