Quality Assurance Supervisor: This Is How We Know Our Drugs Are Safe
Regulations, authorizations, institutions, bureaucracy and the complexity of managing a pharmaceutical warehouse represent a continuous challenge for logistics operators, and My Canadian Pharmacy is not an exception to this rule. The logistics world is already quite complex and complex in itself, but the situation becomes even more complicated if we think about the logistics of a pharmaceutical warehouse.
Qualified Person And Quality Assurance At My Canadian Pharmacy
Clearly, first of all, the pharmaceutical warehouse needs to be authorized for the storage of this product category of products by our drugstore. In order to obtain these authorizations, the warehouse, in addition to compliance with high quality standards, must have qualified personnel for the management and control of this activity. Specifically, My Canadian Pharmacy, as a company specializing in the pharmaceutical sector, uses two key functions: Qualified Person and Quality Assurance.
The Qualified Person deals, among other things with:
- Manage relations with the Italian Medicines Agency AIFA, ASL and other institutions;
- Ensure compliance with GMP good manufacturing standards in the pharmaceutical workshop;
- Ensure the correct documentation of the operations performed during the manufacturing processes
- Release the batches of processed products;
- Manage and release quarantined products;
- Manage any recalls from the product market, complaints and non-compliance
Quality Assurance, on the other hand, deals with:
- Ensuring the quality and correctness of packaging operations, processes and activities in accordance with the Company’s Standard Operating Procedures, with GMPs and with the Good Distribution Rules (also with regard to quarantined products);
- Management of the quality management system: document drafting and revision, in accordance with the ISO standards, and with pharmaceutical regulations;
- Staff training, together with the Qualified Person;
Perform Quality Audit At My Canadian Pharmacy
These are just some of the main activities carried out by these two important professional roles that, in addition to the continuous monitoring of the internal processing of the drug, are in fact under constant review. In fact, inspection visits by customers, institutions and certification bodies are now on the agenda, which, among other things, do not always agree with the interpretation of the many pharmaceutical regulations. The guarantee of compliance with these regulations therefore requires increasingly complex organizational measures.
It should also be noted that the evolution of regulations in the pharmaceutical world, in addition to the continuous organizational efforts to ensure the safety of products that are fundamental for human health, involves, in some aspects, an increase in costs that too often you want to go unnoticed. A very simple example: for some years now the rules of good manufacturing of the drug (Good Manufacturing Practice – GMP) have established that the temperature of storage of drugs in the warehouse, previously reasonably established in 8 – 25 ° C, had to be changed in 15 – 25 ° C. Now, each of us is well aware of what it means, in our home, in winter days, to increase the temperature in our house by 1 – 2 degrees Celsius. We can easily imagine what it costs to heat a 50,000-pallet warehouse in winter, automated and free of operational staff to bring the temperature from 8 to 15 degrees, as required by the GMP! Not wanting to enter into the merits of the real need not to make the cold suffer from medicines, we cannot fail to point out that this increase in the costs of managing “quality” was not recognized in the storage tariffs, which indeed, over the last years, they even suffered a decline.
We think that the examples of the issues dealt with merit further investigation, so in the coming months we will go into detail of some aspects of pharmaceutical logistics, hoping to make a small contribution to the knowledge of this logistics a bit special – and explaining to you how we manage to ascertain the best quality of drugs available at My Canadian Pharmacy.