GLP

In today’s competitive and compliance-driven environment, ISO GLP (Good Laboratory Practice) certification has become an essential mark of credibility for laboratories, research organizations, and pharmaceutical testing units. Quality Asia Certification offers globally recognized GLP certification services in line with OECD GLP Principles, ensuring that your laboratory practices meet international quality, safety, and ethical standards.

Our certification process is tailored to support research organizations, contract research organizations (CROs), testing labs, and clinical trial sites to achieve compliance and improve data integrity.

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Increase Your Competitive Edge

What is GLP?

GLP stands for Good Laboratory Practice, a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported. The standard originated under the OECD (Organisation for Economic Co-operation and Development) and ensures reproducibility, reliability, and integrity of laboratory data.

ISO GLP Certification provided by Quality Asia Certification assesses whether your organization’s facilities, personnel, procedures, equipment, test systems, and reporting align with international GLP principles. While not an ISO standard in itself, GLP certification is often categorized under ISO regulatory frameworks for testing and calibration laboratories.

Why is GLP important?

With increasing regulatory scrutiny and data integrity concerns, achieving ISO GLP certification enhances your organization's trustworthiness. Whether you are submitting data for government approval or offering R&D services globally, GLP compliance is crucial.

GLP certification is increasingly requested by regulatory bodies such as:

  1. CDSCO (India)
  2. US FDA
  3. EMA (Europe)
  4. OECD member countries

Having a recognized third-party certification from Quality Asia Certification enhances your laboratory’s eligibility to participate in international studies and tender-based research contracts.

What are the benefits of GLP?

  1. Ensures structured, traceable, and reliable lab operations
  2. Aligns with international testing standards (OECD, US FDA, WHO)
  3. Boosts credibility with regulators, sponsors, and clients
  4. Increases compliance with ethical practices in testing
  5. Minimizes risks of data rejection in audits and inspections
  6. Establishes trust in data quality across research cycles

What kind of businesses can benefit from GLP?

Implementing ISO GLP not only ensures better laboratory performance but also offers multiple long-term business advantages:

  1. Increased International Acceptance: Compliant data is more likely to be accepted by international regulatory authorities and buyers.
  2. Enhanced Market Access: Certification improves eligibility for global research collaborations, CRO contracts, and funding opportunities.
  3. Competitive Edge: Gives your organization a reputational edge over non-certified labs.
  4. Operational Efficiency: Streamlines lab processes and reduces redundancy, saving cost and time.
  5. Client Confidence: Builds greater transparency and trust among stakeholders and sponsors.
  6. Regulatory Readiness: Improves readiness for audits, inspections, and compliance with legal obligations.
  7. Data Integrity & Reproducibility: Promotes consistent data recording, validation, and traceability.


Top Tips on making ISO 9001 effective for you.

#1

Top management commitment while practicing and accomplishing the standard is the key to success.

#2

Keeping staff informed about the ongoing practices, a well-communicated plan would increase the motivation and zeal of working in them.

#3

Making sure that the various departments of the organization work as a team for the benefit of the organization and customers as well.

#4

Review systems, policies, processes, and procedures for a smooth working of QMS.

#5

Speaking to customers & suppliers while getting feedback & working on improvements.

#6

Training staff carrying out the internal audits with the opportunity for improvement.

#7

Celebrate your achievement and use the QualityAsia Assurance Mark on your literature, promotional material, and website.

#8

Ensure continuous improvement by regularly reviewing and updating your quality management practices.

#9

Promote a culture of quality by encouraging innovation, accountability, and employee involvement at every level of the organization.

Why QualityAsia?

QualityAsia always vanguard in the auditing and governing of internationally acclaimed standards practices. At QualityAsia, we focus on driving the success of our clients through creating excellence with our trained professional auditors. The content of our service provision, comply with international certification rules defined by the accreditation bodies without burning a hole in your pocket. We will take you through the journey of audits with our best kept audit practices, viz.:

Initial Certification – Stage 1 (Preparatory Phase)
  • Thorough documented information review.
  • Exchange of information with staff through online or onsite presence.
  • Identification of key performances, processes & objectives as per the standard requisites.
  • Analysis of facilities, infrastructure, systems and processes in regard with the requested certification scope with a resource allocation review.

Initial Certification – Stage 2 (On-site Audit)
  • Measurement, reporting & reviewing the performances against key performances objectives.
  • Reviewing the suitability of the system meeting the legal, regulatory & contractual requirements.
  • Operational control of processes, internal audits & management reviews while understanding the responsibilities for the policies.
  • Conclusion based on prescriptive requirements, policy, performance objectives, staff skill, operations, procedures, internal audits, etc.


    Surveillance & Certification Renewal

    Drawing out the scrutiny on various aspects of the previously done audits on effectiveness while reviewing the various processes and control of the operations in the QMS and finally going for the recertification.

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