GMP certificate: why it matters and how to get one

Introduction

A Good Manufacturing Practice (GMP) certificate is an international standard confirming the quality of pharmaceutical manufacturing.

Key requirements

To obtain the certificate, a manufacturing facility must meet established sanitary and quality control requirements.

Required documents

• Description of the manufacturing process
• Quality control system documentation
• Information on raw material sources

Process steps

1. Step 1: Preliminary audit
2. Step 2: Addressing identified gaps
3. Step 3: Official certification inspection

Conclusion

Without a GMP certificate, importing medicines into most markets is not possible.