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GLP and ISO 17025 (Clause Improvement)

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Guest user Created:   Oct 13, 2020 Last commented:   Oct 13, 2020

GLP and ISO 17025 (Clause Improvement)

My question is regarding GLP. Are there written requirements of GLP anywhere .which would be fulfilled to by lab .

More over in ISO 17025 we have clause of improvements. If the lab will get same results as was in previous year then it means the lab has maintained its success or maintained the implemented rules. Does this would be counted in improvement ? Further to fulfill the clause of improvement what would you suggest to do ?

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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Tracey Evans Oct 13, 2020

You asked

"My question is regarding GLP. Are there written requirements of GLP anywhere .which would be fulfilled to by lab.

Indeed, look at the Economic Cooperation and Development (OECD) principles of Good Laboratory Practice (GLP) at https://www.oecd.org/chemicalsafety/testing/good-laboratory-practiceglp.htm and  US Food and Drug Administration (FDA) Electronic Code of Federal Regulations Title 21 → Chapter I → Subchapter A → Part 58 from https://www.ecfr.gov/

Typically, a country will have specific GLP requirements and an official GLP monitoring authority that conducts study audits and provides certificates of compliance to organisations for compliance to the OECD principles of GLP.

You also asked 

If the lab will get same results as was in previous year then it means the lab has maintained its success or maintained the implemented rules. Does this would be counted in improvement? 

No this is not improvement. The term “improvement” relates to an increased ability to fulfil requirements, not just having maintained or met the same “level” of implementation.

And you asked 

Further to fulfill the clause of improvement what would you suggest to do ?"

Improvement involves meeting requirements in a more effective and or efficient way. It could also come from improved monitoring and traceability of objective evidence. Opportunities for improvement can be identified through: 

  • feedback from customers and personnel (positive and negative)
  • review of operational procedures, risk and opportunity assessments, audits, and management review
  • data and trend analysis, including quality control (internal and proficiency testing), corrective actions, audits, and root cause / corrective action trends
  • analyzing outcomes and use the evaluation to improve customer service, specific laboratory activities, and the overall management system

You should use your procedure for addressing risks and opportunities to select which improvements to make. 

For more information regarding actions to address risks and opportunities, see the ISO 17025 toolkit document template: Addressing Risks and Opportunities Procedure at https://advisera.com/17025academy/documentation/addressing-risks-and-opportunities-procedure/ 

Also have a look at a previous response to questions

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Oct 13, 2020

Oct 13, 2020