Good Clinical Pratice (GCP) Inspections
Recent Updates
Overview
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials involving human subjects. It is important that this standard is upheld at all times to protect the rights, safety, and well-being of the study subjects, as well as to ensure the integrity of clinical trial data.
A GCP Inspection is an official review of documents, facilities, records and any other resources related to the conduct of clinical trials. Inspections can occur while the trial is ongoing, when subjects are currently enrolled, or after the completion of the trial. Complaints or suspicions of serious non-compliance, such as data integrity issues or scientific/ethical misconduct, may also trigger an inspection.
In Malaysia, the National Pharmaceutical Regulatory Agency (NPRA) is one of the authorities responsible for conducting GCP inspections, in addition to the compliance review audit conducted by the Medical Research and Ethics Committee (MREC). The NPRA’s GCP inspection focuses on ensuring that clinical trials comply with regulatory and ethical requirements, particularly those outlined in the Control of Drugs and Cosmetics Regulations 1984 and the Malaysian Guidelines for Good Clinical Practice (GCP). The scope of NPRA inspections includes verifying the implementation of GCP principles, assessing data integrity, and ensuring that study subjects’ rights and safety are protected.
The inspection may be conducted at the clinical trial site, which is usually a hospital, as well as the sponsor's or Contract Research Organisation's (CRO) facilities, clinical laboratories, archive facilities, and other establishments deemed appropriate by the NPRA. The inspection may also take place at multiple sites where required. The Drug Control Authority (DCA) has endorsed Malaysian Guidelines for Good Clinical Practice Inspection in accordance with the Regulation 29 under Control of Drugs and Cosmetics Regulation 1984 in the 221st meeting on the 29th October 2009.
Foreign drug regulatory agencies where the products are to be registered/marketed may also conduct GCP inspections to trial sites, sponsors, CROs, and other establishments in Malaysia. Foreign drug regulatory agencies such as the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA) regularly conduct GCP inspections of the trial site in Malaysia, and the NPRA inspectors may join the inspection.
The following clinical trials may be subjected to GCP Inspections:
- Clinical trials involving new drug products and biologics that are subject to the requirements of the Drug Registration Guidance Document (DRGD).
- Clinical trials involving investigational products (IP) regulated under Clinical Trial Import Licence (CTIL)/Clinical Trial Exemptions (CTX) that are subject to the requirements of the Malaysian Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption.
- Clinical trials of therapeutic products and Class-2 cell and gene therapy products (CGTPs) that are subject to the requirements of Guidance Document and Guidelines for Registration of Cell and Gene Therapy Products (CGTPs) in Malaysia
Objectives of GCP Inspections
The objectives of GCP Inspections are to:
- Ensure the rights, safety and well-being of study subjects have been protected.
- Determine whether the trial was conducted in accordance with applicable regulatory requirements, ethical standards and Malaysian Guidelines for Good Clinical Practice.
- Determine whether the data submitted in the dossier are credible and accurate.
- Assure the integrity of scientific testing and study conduct.
- Take corrective action to ensure compliance and enforcement actions when deemed necessary.
Categories of GCP Inspections
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Categories |
Description |
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Phase 1 Unit |
Designed to give assurance that units listed in the NPRA Phase I programme not only meet but surpass basic requirements under the principle of GCP. This programme also provides assurance to sponsors that the accredited units listed make significant contributions to enhancing the safety of volunteers and is considered to be the centre of excellence for Phase I research. |
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Routine |
Usually applies to completed clinical trials and are announced inspections., Routine inspections are conducted as part of the drug registration application process. |
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Triggered |
Conducted as a result of requests, complaints or reports to NPRA on suspected violations of regulations. Such types of inspections may be announced and apply to ongoing or completed clinical trials. |
GCP Inspection process
Opening meeting
Interviews with study staff
Visit to facilities
Document review
Essential documents will be reviewed.
Interim Meeting or Daily Wrap-Up
Closing meeting
Grading of GCP Inspection Findings
Observations made during the inspection will be discussed in a technical meeting to determine their grading before being included in the final inspection report as findings.
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Grading |
Impact on the goals of GCP |
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Critical |
Conditions, practices or processes that adversely affect the rights, safety or well-being of the subjects and/or the quality and integrity of data. |
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Major |
Conditions, practices or processes that might adversely affect the rights, safety or well-being of the subjects and/or the quality and integrity of data. |
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Minor |
Conditions, practices or processes that would not be expected to adversely affect the rights, safety or well-being of the subjects and/or the quality and integrity of data. |
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Comment |
The observations might lead to suggestions on how to improve quality or reduce the possibility for non-compliance to occur in the future. Comments are not classified as findings, and Corrective and Preventive Actions (CAPA) are not mandated. |
Remote Inspection
NPRA may initiate or request to conduct remote GCP Inspection whenever we determine a remote GCP inspection is appropriate to help fulfil the agency’s regulatory responsibilities, for example:
- In situations where NPRA cannot conduct an on-site inspection due to travel limitations brought on by Public Health Emergencies, natural disasters or other situations where travel is not possible.
- For sponsors or CROs who do not have a physical office located in Malaysia.
The preparation for a remote inspection is similar to that of an on-site inspection. The process for document reviews, interviews, and document requests remains unchanged, regardless of whether the inspector is conducting the inspection remotely from their office.
Protocol Deviation Submission
The CTIL/CTX holder is responsible for updating or reporting any information relevant to the product or the application, which includes the Protocol Deviation Reporting. The details of the requirements are outlined in the Malaysia Guideline for Application for CTIL and CTX.
Protocol Deviation Submission Requirements:
- All submissions must be made in electronic format only; hard copies will not be accepted.
- Each submission must include a cover letter on official company letterhead.
- The protocol deviation report should be attached to the email in Excel format and renamed according to the reference number.
- The report must adhere to the format specified in Form N3-FR-27 CTIL/CTX Protocol Deviation Report Template available on the NPRA website.
- All correspondence related to protocol deviations should be sent to mygcp@npra.gov.my.
- If no protocol deviation occurs during the reporting period, notification to NPRA is not required.
Phase 1 Unit Inspection & Accreditation Programme
Enquiries and Contact Information
For any enquiries, please contact sgcpglp@npra.gov.my