logo
certificate
qci
qci

GMP ICH Q7 Certification in Kenya

Home

GMP ICH Q7 Certification

What Is GMP ICH Q7 Certification ?

GMP ICH Q7 Certification in Kenya suggests respect to the Good Manufacturing Practices (GMP) requirements for active pharmaceutical components (APIs) set forth by the International Council for Harmonization. The pharmaceutical manufacturers in Kenya are guaranteed to adhere to internationally recognized quality and safety standards in the API production lifecycle, including staff, documentation, equipment, and process control, thanks to this accreditation.

Gaining ICH Q7 compliance increases the likelihood of regulatory approval from agencies such as the US FDA and EMA, increases trust with foreign purchasers, and guarantees the quality and consistency. Kenya's thriving pharmaceutical industry, which aims to enter regulated international markets, really needs it.

Soft Skills Training Ahmedabad
Benefits of GMP ICH Q7 Certification in Kenya
  • Regulatory Compliance : Ensures compliance with international regulations, including US FDA, EMA, and WHO standards.
  • Improved Product Quality : Establishes consistent manufacturing practices, reducing contamination and deviations.
  • Enhanced Market Access : Facilitates entry into global pharmaceutical markets by meeting buyer and regulator expectations.
  • Operational Efficiency : Streamlines processes, minimizes waste, and improves production reliability.
  • Risk Management : Reduces the likelihood of product recalls and regulatory actions through systematic controls.
  • Competitive Advantage : Strengthens your reputation and credibility in Kenya’s pharmaceutical industry.
  • Increased Customer Confidence : Demonstrates commitment to safety, quality, and consistency in API production.
How to Achieve GMP ICH Q7 Certification in Kenya?

The use of a quality management system that conforms with ICH Q7 criteria is a prerequisite for pharmaceutical and API firms to obtain GMP ICH Q7 certification in Kenya. validation, rigorous control over testing and manufacturing processes, comprehensive documentation, and employee training are all necessary for this. After doing a gap analysis to find areas that require growth, internal audits are conducted to verify compliance. A recognized certification organization performs an external audit after the system is operational. After complete successfully, the business receives certification, which increases export options and controls approval.

Frequently Asked Questions

1. What is GMP ICH Q7 Certification? + GMP ICH Q7 is a guideline for Good Manufacturing Practices specifically for the manufacturing of Active Pharmaceutical Ingredients (APIs). Certification ensures compliance with quality standards throughout the production process.
2. Who needs GMP ICH Q7 Certification? + Pharmaceutical companies and API manufacturers in Kenya seeking to ensure high-quality production and regulatory compliance.
3. How to achieve GMP ICH Q7 Certification in Kenya? +

Implement required GMP processes, train staff, document procedures, conduct internal audits, and undergo an external audit by a recognized certification body.

4. How long does certification take?+ Typically, 6 to 12 months depending on organizational readiness.
5. Who certifies GMP ICH Q7 in Kenya?+ Accredited certification bodies and regulatory agencies conduct audits and grant certification.
Request A Quote