GOOD MANUFACTURING PRACTICE CERTIFICATION
Overview
Good manufacturing practice (GMP) is the minimum standard that a medicines manufacturer must meet in their production processes. Products must:
- Be of consistent high quality.
- Be appropriate to their intended use.
- Meet the requirements of the marketing authorisation (MA) or product specification
GMP Inspections
Every manufacturer and wholesaler has a risk rating or score and we prioritise inspections for those with the highest ratings or scores. You will be told about these inspections in advance, although under the short-notice inspection programme we may send little or no notification. At the inspection, GMP and/or GDP inspectors examine the systems used to manufacture and/or distribute medicines.
During an inspection the inspection team will:
- Interview relevant personnel.
- Review documents.
- Conduct site visits.
Site visits may include any facility or process involved in producing, purchasing and distributing medicines, including:
- Manufacturing areas.
- Quality control (QC) laboratories.
- Stock and stock management storage areas.
- Temperature monitoring returns areas.
- Purchasing and sales functions.
- Transportation arrangements.
The inspection team may ask for additional documentation and samples for testing during the inspection. They may also change the focus of the inspection if they suspect serious non-compliance.
At the closing meeting the inspector will provide feedback and discuss any deficiencies with you and agree timelines for corrective actions.
Your GMP rating is based on
- Your compliance report.
- Internal information about.
- Previous inspection history organisational changes
You can’t appeal against your rating.
Actions after the inspection
After the inspection closing meeting, you will receive a post inspection letter confirming any deficiencies found.
You must respond to the inspector by email to confirm the proposed corrective actions and dates for when these actions will be completed. The inspector will review your response. If they accept it, you will receive a GMP or GDP certificate with your inspection report. An unacceptable response may lead to compliance escalation if further requests for information are unsatisfactory.
If you’re being inspected for GMP you should complete an interim assessment if there are changes to your site following your first inspection.
The daily rate inspection fee includes preparation for, reporting and close-out of the inspection. Inspections with critical findings or other significant non-compliance requiring referral to the GMDP Compliance Management Team and/or Inspection Action Group may require the inspector(s) to spend additional time beyond that covered by the daily rate overseeing the adequacy of the company’s Corrective and Preventative Actions (CAPA) and the company’s return to compliance. For such inspections, an office-based inspection fee may be charged for this additional time spent by the inspector(s) on such activities (for example, reviewing CAPA plans, impact assessments and periodic CAPA status updates).
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