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ISO 17025

ISO 17025 Certification

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ISO 17025

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  1. ISO/IEC 17025 Certification: Improving Precision in Nigeria's Pharmaceutical Testing Laboratories The Importance of Accurate Lab Tests in Nigeria's Pharmaceutical Industry The Nigerian pharmaceutical industry is vital to public health because it makes sure the medicines are safe, effective, and dependable. However, one major concern testing laboratories face is their lack of consistency. Inaccurate test results lead to the creation of unsafe drugs, fines, and a tarnished reputation. Due to the growing need for quality medicine, especially after COVID-19, pharmaceutical laboratories are now required to demonstrate the accuracy of their results. This is where ISO/IEC 17025 becomes helpful. What is ISO/IEC 17025? ISO/IEC 17025 is an international standard that is used for testing and calibration laboratories. It describes requirements for the trust, impartiality, and operational

  2. consistency of laboratories. It guarantees that test outcomes are valid and has technical acceptability as well as authority to be acknowledged globally. Whether you manage a drug testing facility in Lagos or a microbiology lab in Anambra, ISO/IEC 17025 certification assists you: •Enhancing the precision, consistency, and reliability of test results. •Achieving compliance with international testing standards in pharmaceuticals. •Cultivating confidence of clients and regulatory authorities. •Reducing operational and retest errors. •Increasing eligibility for international partnership and contract opportunities. The Need for ISO/IEC 17025 Certificate for Pharmaceutical Labs in Nigeria Pharmaceutical laboratories in Nigeria are facing tightening scrutiny, both from NAFDAC as well as global stakeholders, to authenticate the validation of their methods within a reasonable timeframe. The existence of counterfeit drugs renders trust in lab results paramount. Obtaining an ISO/IEC 17025 certification: •Guarantees the technical competence of the laboratory. •Acceptance of NAFDAC and WHO regulatory expectations. •Increased international cooperation and funding. •Efficacious control of errors related to drug efficacy and toxicity reports. •Control over internal processes and training of the personnel.

  3. Primary Advantages of ISO/IEC 17025 for Pharma Labs Result Traceability All results, including pH, measurement, and concentration of active ingredients, are traceable and verifiable against international standards. This facilitates confidence in every certificate issued. Validation of Techniques Each laboratory method is subjected to testing for accuracy and reproducibility, thus minimizing errors in test reports that may impede the approval of drugs. Internal Audits of Quality Control System features are integrated within the workflow for automated calibration in order to improve data handling and duplicates incrementally. Competency of Staffing Level Assurance Lab technicians are qualified and trained through standard operating procedures that enhance check accuracy and trust in outcome reliability. Global Acceptance Certified labs can legally and medically certify test results for other countries. This is critical for businesses that manufacture pharmaceuticals to export or market at an international level. Actual Example: Lagos-Based Drug Quality Laboratory A pharmaceutical testing lab based in Lagos had issues with samples being reported late and inaccurately being analyzed using HPLC. After the implementation of ISO/IEC 17025 standards with the help of MAXICERT: •SOPs for sample intake and analysis reporting were developed and subsequently document systems were implemented and training sessions conducted. •Staff were retrained on instrument calibration and documentation practices.

  4. •Internal quality audits helped close gaps in processes swiftly. •Result turnaround time improved by 35%. •The lab won a sub-contract with an international pharma company due to its ISO/IEC 17025 status. Why Trusting Became Falsely Tied to ISO/IEC 17025 – Until Now From drug import verification to quality assurance of local medicines, lab accuracy saves lives. Nigerian pharmaceutical labs require not only local compliance but also international competition. Your lab can achieve the following with an ISO/IEC 17025 certification: Provide reliability of technology and data history. Open doors for international testing collaborations. Meet the expectations of the regulators and the pharma companies. Enhance lab productivity and minimize repeating tests. Are You Looking for Assistance with Attaining ISO/IEC 17025 Certification? MAXICERT provides support to pharmaceutical testing laboratories throughout Nigeria, including Lagos, Ogun, Rivers, and Kaduna. We offer the following services for ISO/IEC 17025: • Gap analysis and documentation setup • Method validation and internal auditing systems • Training for lab operations, calibration, and other staff roles • Guidance during external evaluations and audits Applicable to both new and established laboratories. For additional information: ISO/IEC 17025 Certification in Nigeria Browse our visual highlights on Pinterest and explore fresh insights on Rider Forums.

  5. Summary In the Nigerian pharmaceutical sector, having a credible lab is not optional — it is mandatory. With the certification, labs can fulfill the market's increasing requirements for precision, reliability, and global acceptance. The time has come to shift from estimation to standardized protocols accepted internationally. Frequently Asked Questions on ISO/IEC 17025 for Nigerian Labs Q: Can small or start-up pharmaceutical labs apply for ISO/IEC 17025? Yes. The standard is flexible to accommodate both small and large testing facilities. Q: Does buying new equipment automatically come with getting certified? Not really. It has more to do with the maintenance, calibration, and documentation of existing resources. Q: Does certifying a laboratory interrupt laboratory operation? Not likely. With structured guidance, labs can continue to function through the implementation of certifying procedures. Q: What is the length of time required to complete certification? With appropriate guidance, it can be completed in 3–4 months. That time frame is typical.

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