Anyone who has dealt with GMP before knows: GMP rules are general, openly worded and leave room for interpretation. In most cases there are no clear instructions on how to do something, but only for what has to be done.
This is exactly where the uncertainty of many pharmacists begins: What sets of standards are relevant for pharmacy operations? What is needed for a detailed trading license? And what for a production license?
What are the differences between a production license for small versus large quantities? What are the requirements for facilities and equipment? What needs to be inspected and documented, and when?
This much is clear: the GMP requirements for a small quantity production license differ from those for a large quantity production license. But how, why and where? Competent consulting is required here! Experienced and with an eye for specifics.
Clarity Around the Production License
A pharmacy that wants to produce pharmaceutical products has to deal with numerous questions up front. Like the following, for example:
- When is a pharmacy permitted to produce pharmaceutical products?
- What licenses are relevant? Can the canton issue me a license, or do I have to contact Swissmedic? And how do I know who is responsible for me?
- What is the general procedure to obtain a production license?
- Under what conditions is a pharmacy permitted to supply third parties (other pharmacies, doctors, hospitals etc.)? What may be delivered, in what quantities, and what does “job order production” mean?
- What do the quality standards for “GMP in small quantities” encompass in concrete terms? What is the quantity limit for pharmaceutical product production and what does an appropriate quality assurance system for a pharmaceutical product production license look like anyway?
Certainly that is far from covering all the questions related to production. But not only topics related to production are of interest. The GM requirements for transporting pharmaceutical products, or for rooms and equipment, also come into focus and raise questions.
For all of these points, gempex is a competent and reliable partner that not only helps resolve anything that is unclear but also offers advice in all phases and assists with the implementation.
Meeting GMP Regulations Purposefully and Efficiently
The dynamic further development of guidelines poses an added challenge for many companies. The legal basis at the canton and federal levels as well as the national and international GMP rules and standards are not a fixed construct. The rules, guidelines and regulations, such as the Therapeutic Products Act (HMG) or Pharmacopoeia Helvetica (Ph. Helv.) for example, are subject to ongoing changes. Amendments, corrections and enhancements are always being implemented and need to be observed. So it is not always possible to quickly tell at a glance what that means for pharmacy operations and pharmaceutical product production, nor what the consequences are for a specific operation.
The GMP experts at gempex always keep their knowledge up to date. Combined with expertise acquired over many years, gempex is a competent and professional partner when it comes to GMP rules, guidelines and regulations.
From GAP Analysis to Full Service
Consulting begins with a gap analysis that provides a picture of the GMP system’s current state (if there is one) and identifies possible gaps. A catalogue of measures, always recommending only as much as necessary and never as much as possible, offers concrete recommendations. If desired, the gempex GMP experts also assist with their implementation.
If a quality management system has not been established yet, but is required for pharmaceutical product production in the pharmacy, gempex offers planning aids for any scope and assists with the system implementation. Here too the consultants place great emphasis on not allowing efforts to get out of hand, always implementing only as much as necessary for the production license.
Once the GMP system has been established and the supervisory and approval authority sets a date, gempex prepares the employees ahead of time with helpful, practical tips and will gladly attend the actual inspection as well.
In whatever phase support is needed or uncertainty exists, gempe with its experienced GMP experts is able to provide an integrated view of a quality management system.
- Current knowledge of legal requirements
- Established knowledge of national and international GMP rules and standards
- Specific solution approaches to meet individual requirements
- Availment of individual, essential services from the complete package, enabling full cost control
- Pragmatic, practical solutions focusing on the true essentials
- Neutral perspective of external experts