What are the main requirements for obtaining GDP certification in Mozambique?

GDP Certification in Mozambique, The Good Distribution Practice (GDP) certification is vital for all companies involved in Mozambique’s storage, transport and distribution of pharmaceuticals. It ensures that pharmaceuticals and other healthcare products are maintained integrity and quality across the entire supply chain. If you’re seeking a GDP-certified product in Mozambique, Here are the primary conditions you must meet:

1. The compliance with Regulatory Authorities

In Mozambique, GDP certification is controlled by the Ministry of Health (MISAU) and the Mozambique Medicines Regulatory Authority (Autoridade Nacional Reguladora De Medicamentos ANARME). The companies must ensure that their activities align with local distribution of pharmaceuticals regulations and global GDP guidelines developed through the World Health Organization (WHO).

2. Quality Management System (QMS)

A clearly defined QMS, a well-defined Management System (QMS), is crucial for obtaining GDP certification. This must include:

• Standard Operating Procedures (SOPs) for storing, transporting, and handling pharmaceutical products.

• Risk management procedures to avoid cross-contamination, confusion, and mistakes.

• Regular internal audits are conducted to ensure respect for GDP regulations.

3. Proper Storage and Distribution Conditions

Pharmaceutical products must be kept in conditions that do not allow deterioration. This includes:

• Temperature and humidity control The proper temperature monitoring system (e.g. the management of cold chains for vaccines).

• Clean and secure Warehousing Storage facilities should be clean and safe from theft or manipulation.

• Inventory Management Effective tracking of the products by batch numbers and expiry dates.

4. Personnel Training and Competency

Everyone employed in the distribution of pharmaceuticals should be educated on GDP principles. This includes:

• Regularly scheduled training covering handling storage, transport, and documenting.

• Be aware of the legal obligations and ethical issues in the distribution of pharmaceuticals.

• The designation of the responsible person (RP) to oversee the compliance with GDP.

5. Documentation and Record-Keeping

Achieving accurate documentation is a crucial condition to obtain GDP certification. Businesses must ensure:

• Documentation of movements of products such as delivery receipts and receipts.

• Monitoring logs of temperature and calibration reports for equipment.

• The audit reports are followed by corrective action plans to address any violations.

6. Transport and Distribution Standards

Companies that are GDP certified must:

• The proper conditions for transport to avoid contamination or damage.

• Verification of subcontractors and suppliers to ensure that they comply with the GDP rules.

• Implement the recall procedure to remove unsafe or defective products when required.

7. Regular Audits and Inspections

To maintain GDP certification, companies have to go through regular annual internal audits and audits conducted by regulatory agencies. The inspectors of ANARME or accredited bodies will evaluate compliance with GDP guidelines.

Why Factocert for GDP Certification in Mozambique?

If you’re unsure of how much GDP consultants will cost in Mozambique, you can always contact us by email at contact@factocert.com and provide us with all the details about your company so that we can assess the necessary steps to assist you in obtaining the certification, or you can either visit our official website at www.factocert.com to obtain the certification and give our help desk your contact details so that they can set up a call for one of our experts to understand your certification needs.

For more information, visit : GDP Certification in Mozambique