The new guidance for Good Distribution Practice was published March 7th 2013, and came into law in September 2013.
Some of the updated guidance and legislation will potentially leave you at risk of major or critical failings in your next inspection, if you don’t catch up.
Significant changes are noted around the following areas;
1) Quality Management. The key updates are;
• Change control
• CAPA – Corrective Action, Preventative Action
• Quality Risk Management principles
2) Personnel. The key updates are;
• The Responsible Person should be continuously contactable, and although may delegate duties, may not delegate (or abdicate) responsibilities
• Staff must be trained in Good Distribution Practice prior to commencement of their role, and the Responsible Person must have regular training. This must, of course, be evidenced.
• Personnel hygiene is now a factor for review
3) Premises and Equipment;
• Records of repair, maintenance and calibration of key equipment is necessary
• Computer systems should be validated
• Key equipment should be qualified and validated
• Documentation should be readily understood by staff
• Intelligent version control and emphasis on keeping procedures and documents current
• Verification of suppliers being compliant with Good Distribution Practice (GDP)
• Due diligence checks on the supplier base
• Monitoring of sales to identify potential diversion or misuse of medicines
• Control reports for sourcing goods from EEA States
• FEFO, not FIFO – First Expired, First out… not First In, First Out
• Regular inventories / stock takes to be performed
• Exports outside of the EEA require a wholesale authorisation and full Good Distribution Practice (GDP) is applied
6) Complaints, Returns, Suspected Falsified Medicinal Products and Medicinal Product Recalls;
• No significant changes
• New guide suggests a period of ten days may be an acceptable time limit to products that have been outside of the licenced chain. Current guidance on acceptance of returns to saleable stock apply.
• Recovered stolen medicines may NOT be returned to saleable stock
7) Outsourced Activities;
• Contacted out activities must now be part of the management review and a full set of requirements for such outsourcing has been published, and remains in line with current MHRA expectations.
8) Self Inspections
• Self inspections may not be carried out by staff other than the RP
• Independent external audits are recommended, but may not replace the self inspection
• All reports must be subject to CAPA principles
• All products to be shipped within label conditions
• Excursions of temperature must be reported and investigated
• Risk assessments should be made of any delivery paths to identify when temperature control may be required
• Wherever possible dedicated vehicles should be used, and procedures put in place to cover non-dedicated vehicles
• Contacts must be put in place with transporters
10) Specific Provisions for Brokers
• Sets out the new requirements for records and procedures for brokers. This is a new area completely.
Review a PDF document of the most significant changes here;
Make sure you haven’t been left behind.
For a no obligation conversation please use the “Contact Us” page.
20 Nov 2018
17 Oct 2018
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