Quality Management Systems based in Good Distribution Practices (GDPs) of Medicines for Human Use, were originally derived from GMPs (Good Manufacturing Practices), quite well known for drug manufacturers, but not so the rest. Its focus is not so much customer satisfaction, as is ISO 9001:2008, ISO 9001:2015 and EFQM, because they are aimed at ensuring product quality at any point in the manufacturing chain (GMPs) or chain supply (GDPs), and of course as a result, end customer satisfaction ultimately but clearly based on standards of excellence in product and manipulation quality. GDPs are getting better known due to legislation to protect patient's health (pharmaceuticals distribution), consumer's health (cosmetics), etc.
Sorry, this certificate is from Spain, so it's in Spanish !
In the pharmaceutical sector it has addressed a key link, distribution warehouses and the activity of distribution, including whether or not such as contract warehouses, warehouses under customs control, etc. First Royal Decree 782/2013 and finally the "Guidelines on good practice for the distribution of medicinal products for human use" (EU GDP guidelines) have had a significant impact on the sector, which has been catching up in the implementation of quality systems beyond SOPs (Standard Operating Procedures), records, etc. There are somre requirements for these new systems being implemented since 2014, to be certified, such as orientation to product quality and patient, computer validations, supplier audits (especially transport), controlled and monitored environment conditions (temperature, humidity, sunlight and cleaning), risk analysis, mapping and warehouse vehicles (also containers for special medications such as heat labile), transport routes validation etc.
[title]ATEC+ID develops and implements GDPs quality systems, for their certification, may include:[/title]
- Warehouse Temperature Mapping: Temperature mapping, and if necessary also humidity, allowing to ensure T & H behaviour fit to a range of temperatures where you can operate, usually 2-8ºC, or 15-25ºC
- Containers Mapping: T & H mapping, for either small or big containers as like lorry boxes, usually ATP certified.
- Transport suppliers or owned audit: Detailed revision of all aspects transport suppliers must comply, as is transport conditions tracking, its verification, the mapping and validation availability, and documents.
- Information Systems Validation: This validation, qualification or re-qualification refers to systems used in asurance about incidents, data security, data loss prevention, anti intrusion, etc, and is developed also according to 21 CFR Part 11.
- Probes and equipment calibration management.
- Quality system implementation.
- Training on GDPs operations performance and quality system.
In the Cosmetics Sector, there's also an evolution to secure the supply chain, to further ensure the health, etc, with an implementation of control mechanisms and communication for the introduction of new products on the market, etc, naming a responsible person. This aspect of the person responsible, is similar in the pharmaceutical distribution sector, where it's called the Technical Director. It is important for pharmacies, to ensure they meet this standard if they sell cosmetics.
What are the most common difficulties in its implementation and certification?
- Risks in all the activity and processes have never been considered, and it's neither clear how to do it, manage it, and what are the consequences in CAPA management and the rest of controls.
- The risk management requirement is appreciated as something bringing only costs. Adding value to the business, risk reduction and business continuity, and their impact in insurance price negotiation are not appreciated.
- Process validation has never been considered, and it's not really understood what validation means, and what brings to the business. Processes validation means to check methodically and analytically that these processes are well designed from the begining, their result is always the expected one, and that that result always ensures product quality.
- Information system validation is unknown, and what it is for.
- ¿How do I sudit my transport suppliers? ¿What I demand from them?.
- How is a service contract to provide storage or transportation service?
The list is long, ask us about it !!! we'll be delighted to hel you