New EU GDP Guideline – What Are The Main Changes?
The new EU GDP Guideline of 8 March 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01) is not a slight revision of the previous guideline as it contains completely new content. It is addressed to wholesale distributors, but applies also to other stakeholders involved in the distribution of medicinal products such as brokers.
The Table of content is structured in a similar way as the EU GMP Volume 4 and sounds familiar to the pharmaceutical reader. It is divided in the following chapters:
1. Quality management
3. Premises and equipment
6. Complaints, returns, falsified medicines and recalls
7. Contract operations
The following items are new:
- Chapter 1 Quality Managementdescribes the Quality System including management review, continuous improvement, Corrective actions / preventive actions (CAPA) and Risk management. Deviations must be investigated and CAPA process implemented. Some interesting precisions are given concerning Risk Management.
- Control and review of any outsourced activities should include risk management principles.
- Temperature mapping of e.g. storage areas should be repeated according to the results of a risk assessment
- A risk based approach should be utilized when planning transportation routes.
Management should have a formal reviewing process including performance indicators to monitor the effectiveness of the quality system.
- Chapter 2 Personnelnow requires the wholesale distributor to designate a Responsible Person with a "desirable" degree in pharmacy. Their main responsibilities are defined as Quality Management / Training / Recall-/ Complaints / Returns / Falsified Medicines /Approval Suppliers / Outsourcing / Records / Self- Inspections and so on. The Responsible Person should fulfill his/her Responsibilities personally and should be continuously contactable. "The RP may delegate duties but not responsibilities".
The organizational structure of the wholesale distributor should be clearly described and the roles and responsibilities of key persons described in job descriptions.
Initial and continuous training have to be planned and recorded.
- Chapter 3 on Premises and Equipmentintroduces new requirements concerning storage areas. They should be temperature mapped and the mapping should include initial mapping prior to use, seasonal variations and be repeated based on risk assessment.
Location of temperature monitors should be based on mapping.
All equipment should be maintained to a suitable standard and preventive maintenance should be registered.
Equipment (e.g. temperature monitoring devices) should be calibrated at defined intervals based on a risk and reliability assessment.
Records should be sustained
Alarm systems should be in place and tested periodically.
Any system replacing physical segregation, such as electronic segregation based on a computerized system, should provide equivalent security and should be validated.
Products pending a decision as to their disposition or products that have been removed from saleable stock should be segregated either physically or through an equivalent electronic system.
- Chapter 3 also includes a Qualification / Validation subchapter which states that key equipment should be qualified and key processes (such as storage, pick and pack) should be validated, based on a documented risk assessment approach. Observed qualification and validation deviations should be investigated.
- Chapter 5 Operationsspecifies that Suppliers must be qualified meaning that they are in possession of a wholesale distribution authorisation, or are in possession of a manufacturing authorisation which covers the product in question. The wholesale distributor should carry out due diligence of new suppliers and periodically recheck that qualification and approval are confirmed.
- Chapter 7 on Contract operationsis adapted from the GMP Chapter 7 and gives Contract Giver responsibility to assess Contract Acceptor competences through audits. Contract Acceptor should have adequate facilities and experience to carry out contracted work safely and efficiently.
- Chapter 9 Transportationstates that "the required storage conditions for medicinal products should be maintained during transportation within the defined limits as described by the manufacturers or on the outer packaging". This new requirement is in contradiction with the new General Chapter of the USP 35. Storage conditions are defined during stability studies following ICH stability instructions. There are no official guidelines for transport conditions. This point will require additional efforts from the manufacturers and distributors even for products having demonstrated sufficiently that their quality remained satisfactory after a short period out of storage conditions as for example during transportation. The transport of products by patients from the pharmacy to their house is another source of deviations from this requirement.
- Chapter 10 defines the responsibilities of brokers. They are subject to registration requirements and should set a quality system in place with special emphasis on emergency plan in case of recalls.
As conclusion, the revised version of the EU GDP requires that wholesaler distributors implement a quality system corresponding to current standards applied in other industries. The timelines for the enforcement is September 8, 2013.
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