What is a GLP audit?

GLP Audits The main goal of GLP regulations is to ensure compliance in the conducting of nonclinical laboratory studies. These studies investigate certain test articles and testing materials. It is a required step in obtaining premarket approval of regulated products.

What is GLP documentation?

GLP requires a documentation standard known as ALCOA: Attributable Legible Contemporaneous Original and Accurate documentation. Not only must the data of the studies (the primary data), be well documented but all other facility data, for example training, equipment, inspections, etc.

What are basic elements of GLP?

The components of Good Laboratory Practice are presented under the headings: type of laboratory work, discipline, management, personnel, premises, safety, equipment, reagents, standard operating procedures, internal quality control, external quality assessment, method, dedicated operating procedure, syllabi, and …

How do you do a laboratory audit?

9 Steps on How to Perform a Laboratory Quality Audit

1. Define the purpose of the audit.
2. Define the scope of the audit.
3. Determine the audit team resources to be used.
4. Identify the authority for the audit.
5. Identify the performance standards to be used.
6. Develop a technical understanding of the processes to be audited.

Do GLP methods need to be validated?

In accordance with the guideline for GLP regulations, all equipments used to generate, measure, or assess data should undergo validation to ensure that this equipment is of appropriate design and capacity and that it will consistently function as intended.

What are 5 Good Laboratory Practices?

Safe Lab Practices

• No Food or Drink.
• Wear Your PPE and Proper Lab Attire.
• Good Hygiene.
• Use Proper Storage Containers.
• Label Your Work Space.
• Don’t Work Alone.
• Stay Focused and Aware of Your Surroundings.
• Participate in Safety Exercises.

What is GLP compliance monitoring?

GLP Compliance Monitoring: The periodic inspection of Test Facilities and/or auditing of studies for the purpose of verifying adherence to GLP Principles.

What is SOP in GLP?

According to the OECD Principles of Good Laboratory Practice (GLP) (OECD, 1998[1]), Standard Operating Procedures (SOPs) are defined as documented procedures which describe how to perform testing methods or activities normally not specified in detail in study plans or Test Guidelines (TGs).

What is ISO audit checklist?

An ISO 9001 audit checklist helps the auditor to gather documentation and information about quality objectives, corrective action, internal issues, and customer satisfaction.

How do you prepare an internal audit checklist?

Internal Audit Planning Checklist

1. Initial Audit Planning.
2. Risk and Process Subject Matter Expertise.
3. Initial Document Request List.
4. Preparing for a Planning Meeting with Business Stakeholders.
5. Preparing the Audit Program.
6. Audit Program and Planning Review.