The long awaited EU GDP Guideline was published in the Official Journal of the European Union by EU Commission on 7 March 2013. This document will replace the current GDP Guideline published in 1994 (94/C 63/03). The draft version was issued in July 2011 for public consultation. EMA received a large number of comments from across the industry (including the EUQPA Working Party). The commission has reviewed and considered carefully the comments received, some have been included in the final published version.
The new GDP Guideline will apply not only to the wholesalers and manufacturers of pharmaceuticals, it also incorporates the specific requirements for the Brokers dealing with pharmaceutical products. The responsibility for the product during storage and distribution will remain with the manufacturers up to the point of sale, where wholesale dealers will take ownership of the products. It is clear that those playing a role in the pharmaceutical supply chain must comply with these requirements, therefore the service providers such as transportation companies, the logistic service providers need to gain good understanding of what is required to be able to provide appropriate service to their clients.
The structure of the final document has been aligned with the structure of the EU GMP Guidelines, now including 10 chapters:
Chapter 1 Quality Management.
Chapter 2 Personnel
Chapter 3 Premises and Equipment
Chapter 4 Documentation
Chapter 5 Operations
Chapter 6 Complaints, Returns, Suspected Falsified Medicinal Products and Medicinal Product Recalls
Chapter 7 Outsourced Activities
Chapter 8 Self-Inspections
Chapter 9 Transportation
Chapter 10 Specific Provisions for Brokers
The draft guideline received a high number of comments and questions on the requirements stated for the role of the Responsible Person (RP) and the required qualification; apart from minor changes this section has remained almost unchanged! The final text states:
"The wholesale distributor must designate a person as Responsible Person. The Responsible Person should meet the qualifications and all conditions provided for by the legislation of the Member State concerned ( 1 ). A degree in pharmacy is desirable. The Responsible Person should have appropriate competence and experience as well as knowledge of and training in GDP. The Responsible Person should fulfil their responsibilities personally and should be continuously contactable. The Responsible Person may delegate duties but not responsibilities"
It is not clear why an RP should be qualified as a Pharmacists, many organisations do not have a pharmacist at their employment. However, if a degree in pharmacy is desirable, then what would be the acceptable alternative? Certainly a Responsible Person should have detailed knowledge about pharmaceutical products. There is no further explanation on how this can be achieved without a degree in Pharmacy. A question of interpretation will also be caused by the statement that a Responsible Person should be "continuously contactable". Does this mean that an external person can be hired for this role? It is stated that the delegation of duties is possible, however, what are the requirements for the person the duties are delegated too, would he need to have the same qualification and training as the RP? The responsibility for defining the qualification requirements is now assigned to the member state authority. This is potentially going to create differences of approach and standards across the community.
Chapter 3 contains information about computerised systems. A validation or "verification studies" should be available before computers will be used. The term computer validation is well defined but what is "appropriate verification studies"? Is this statement referring to the 'Black Box' validation rejected by the authorities in the GMP environment many years ago?
Chapter 9.12 of the draft version included stringent requirements for the transport hubs, including the limit of 24 hours for storage of products. It also comprised the requirements for the hubs to be audited and have a licence to operate if used for a longer period. The new text is more flexible here:
"Where the transportation route includes unloading and reloading or transit storage at a transportation hub, particular attention should be paid to temperature monitoring, cleanliness and the security of any intermediate storage facilities. Provision should be made to minimise the duration of temporary storage while awaiting the next stage of the transportation route."
This new approach will create bigger confusion.The old industry standard for storage at a hub up to the maximum of 72 hours is not included, there is no time limit, and it is not clear how the companies are expected to ensure that the temperature requirements and cleanliness levels are maintained. Also, do the manufacturers and wholesalers need to audit all these hubs?
Risk Assessments will become a key tool for implementation of the new requirements. The final text refers to risk assessment when it comes to the decision if temperature controls are required for transportation:
"Risk assessment of delivery routes should be used to determine where temperature controls are required. Equipment used for temperature monitoring during transport within vehicles and/or containers, should be maintained and calibrated at regular intervals at least once a year"
This article summarizes some important aspects of the GDP Guideline. However, many other aspects need to be considered for implementation. The ECA is therefore currently setting up a new Working Group dealing with this topic with intent to prepare an 'Implementation Guideline' for the Industry.
Update: In December the EU Commission published a revised GDP Guideline