Standard Operating Procedure (SOP) for Good Laboratory Practices (GLP)

Standard Operating Procedure (SOP) for Good Laboratory Practices (GLP)

Purpose:

The purpose of this SOP is to provide guidance on the practices and procedures that must be followed to ensure that laboratory work is conducted in a manner that is reliable, consistent, and in compliance with good laboratory practices (GLP).

Scope:

This SOP applies to all laboratory personnel who conduct laboratory work in facilities that are subject to GLP regulations, such as nonclinical laboratory studies that are used to support the safety evaluation of drugs, food additives, and other regulated products.

Definitions:

• Good laboratory practices (GLP): A set of principles and guidelines that describe the conditions and practices that must be followed to ensure that laboratory work is conducted in a consistent, reliable, and reproducible manner.
• Nonclinical laboratory study: A study that is conducted to evaluate the safety or effectiveness of a regulated product, such as a drug or food additive, in animals or in vitro systems.

Responsibilities:

• Laboratory personnel are responsible for following all GLP practices and procedures outlined in this SOP.
• The Quality Assurance Unit (QAU) is responsible for ensuring that all GLP practices and procedures are followed and for maintaining the quality of laboratory work.

Procedures:

1. All laboratory personnel must be trained in GLP principles and practices before conducting any laboratory work.
2. All laboratory work must be conducted in accordance with written protocols that have been approved by the QAU.
3. All data and records must be accurately and consistently recorded and maintained.
4. All equipment must be calibrated and maintained according to the manufacturer’s instructions and any additional requirements specified in the protocol.
5. All standard operating procedures (SOPs) must be followed as written. Any deviations from the SOP must be documented and justified.
6. All laboratory work must be conducted in a controlled environment that is suitable for the type of work being performed.
7. All laboratory personnel must follow proper personal hygiene practices, such as washing their hands before and after handling samples and wearing appropriate protective clothing.
8. Any unexpected observations or deviations from the protocol must be promptly reported to the QAU.
9. The QAU must review and approve all protocols, data, and records before they are submitted to regulatory authorities.

Record-keeping:

• All data and records related to laboratory work must be accurately and consistently recorded and maintained in accordance with GLP regulations.
• Records must be legible, complete, and clearly identified.
• Records must be stored in a secure location and must be easily retrievable.

Training:

• All laboratory personnel must receive training in GLP principles and practices before conducting any laboratory work.
• Training must be documented and records must be maintained.

References:

• Good Laboratory Practice Regulations, 21 CFR Part 58
• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP)

Approval: This SOP has been reviewed and approved by the QAU.

Date of last review: [insert date]

Date of next review: [insert date]

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