ISO 15378:2017 Documentation Kit

Ensure your pharmaceutical packaging operations meet GMP and ISO requirements with our ISO 15378:2017 Documentation Kit. This ready-to-use, fully customizable documentation kit is specifically designed for manufacturers of primary packaging materials for medicinal products seeking certification to ISO 15378:2017.

What’s Included:

• Quality Manual: Structured to align with ISO 15378:2017 requirements and pharmaceutical packaging GMP principles.
• Standard Operating Procedures (SOPs): Cover all critical processes, including risk management, traceability, contamination control, and regulatory compliance.
• Work Instructions: Step-by-step guidance for consistent execution of packaging-related operations.
• Forms & Formats: Editable templates for process records, quality control, deviation reports, CAPA, and more.
• Internal Audit Checklist: Clause-wise checklist to assess system conformity and identify gaps.
• Management Review Templates: Ready formats to document top management’s review and strategic inputs.

Key Benefits:

• Saves time in preparing ISO 15378:2017 documentation from scratch.
• Suitable for packaging companies serving regulated industries.
• Helps demonstrate compliance with GMP for primary packaging materials.
• Editable in Word and Excel formats, easily tailored to your operations.

Achieve compliance and build trust with regulators and clients. Get your ISO 15378:2017 Documentation Kit today.