The Laboratory Controls Pack: GMP Templates for QC Lab Operations

Is your Quality Control laboratory prepared to defend its data during a regulatory audit? Establishing compliant laboratory controls is one of the most data-intensive and scrutinized areas of GMP. From managing out-of-specification (OOS) investigations to validating analytical methods and running a stability program, the documentation requirements are immense.

The Laboratory Controls Pack is your targeted solution to build a robust and compliant QC laboratory framework. This expert-authored bundle provides a complete set of templates for managing your analytical operations, ensuring data integrity, and meeting the rigorous expectations of cGMP. Stop creating complex laboratory procedures from scratch and implement a proven system for generating reliable and defensible analytical data.

Key Benefits:

• Master OOS Investigations: Implement a best-practice SOP and investigation report for handling out-of-specification and out-of-trend results, a major focus area in any FDA audit.
• Streamline Method Validation: Use comprehensive protocol and report templates to guide you through the process of validating your analytical methods for accuracy, precision, linearity, and specificity.
• Manage Your Stability Program: Implement a formal procedure for initiating, managing, and documenting your stability studies for clinical trial materials to support product shelf-life.
• Ensure Data Integrity: Establish clear rules for laboratory notebook practices, raw data management, and the control of reference standards and reagents to ensure your data is always ALCOA+ compliant.

What's Included in the 10 Document Pack?

This bundle provides all the necessary SOPs, Forms, and Logs to establish control over your cGMP Quality Control laboratory, including:

• SOP-LAB-001: General Laboratory Practices and Safety
• SOP-LAB-002: Laboratory Notebook and Raw Data Management
• SOP-LAB-003: Out-of-Specification (OOS) and Out-of-Trend (OOT) Investigations
• SOP-LAB-004: Analytical Method Validation and Transfer
• SOP-LAB-005: Stability Program for Clinical Trial Materials
• SOP-LAB-006: Management of Laboratory Reference Standards and Reagents
• FORM-LAB-001: OOS-OOT Investigation Report
• FORM-LAB-002: Analytical Method Validation Protocol-Report Template
• FORM-LAB-003: Stability Study Protocol-Report Template
• LOG-LAB-001: Analytical Instrument Calibration-Use Log

Who is this for?

This package is the perfect solution for QC Managers, Laboratory Supervisors, and Analytical Scientists at biotech startups who are tasked with setting up a new QC lab, preparing for an audit, or strengthening their existing laboratory control systems.

Important Disclaimer: Your Role in Implementation

This documentation pack provides a comprehensive set of templates designed to serve as a strong foundation. It is not a ready-to-use, off-the-shelf system. Each template must be reviewed and updated by your organization to accurately reflect your specific processes, equipment, and analytical methods. While these documents are authored based on deep industry experience and cGMP principles, you are ultimately responsible for ensuring that your final, implemented procedures comply with all applicable regulations.