Introduction

Congratulations on taking the crucial step towards GMP (Good Manufacturing Practice) compliance! Developing robust policies and procedures is a foundational element in achieving this goal. While the specific format of your documents may vary, the information they contain is paramount. This blog post will outline the essential sections every GMP production record must include, ensuring your lab functions at the highest quality standards.

Downloadable Guide: Your Roadmap to GMP Success

For your convenience, we’ve created a downloadable guide that expands on these essential sections and provides additional best practices. This guide will serve as a valuable resource as you develop your GMP documentation.

Click here to download your free GMP Production Record Guide!

Essential Sections of a GMP Production Record

1. Scope:

• Clearly define what the document applies to.
• This includes the intended product type(s), product name(s), responsible division(s), and any limitations of the procedure.

2. Equipment:

• List all equipment required for the manufacturing process.
• Include space to document the identification (e.g., serial number) and current status (e.g., calibrated, in use) of each piece of equipment.

3. Material:

• List all materials needed for production, including starting materials, intermediates, and packaging materials.
• Include space for documenting quantities used, identification numbers (e.g., lot numbers), and expiry dates.

4. Personnel:

• Allocate space to document the details of personnel who will be performing critical steps in the process, or who will be responsible for verification.
• This may include qualifications and training records.

5. Procedure:

• Provide detailed, clear, and step-by-step instructions for production personnel to follow.
• Include instructions for any necessary testing or calculations, along with designated areas for documenting the results.
• Ensure all information is recorded concurrently during the production run.
• Specify a method for verifying the recorded information by a second person.

6. Review:

• Dedicate a section for management review and approval of the production record.
• Include space for signatures and dates.
• Similarly, dedicate a section for Quality Assurance (QA) review.
• Ensure completed production documents are reviewed and approved by designated QA personnel.

Conclusion

Implementing these essential sections in your GMP production records is a crucial step towards regulatory compliance and consistent product quality. Combined with the downloadable guide we’ve provided, you’ll be well on your way to achieving GMP manufacturing excellence!

Ready to take your GMP compliance to the next level?

Download our free guide today, and explore additional resources available on Potentcells.com for all your GMP manufacturing needs.