GMP Certification in Kenya:

GMP Certification in Kenya, Vertex Certifiers provides comprehensive, end-to-end GMP certification and compliance services in Kenya, supporting pharmaceutical, food, cosmetics, medical device, and nutraceutical manufacturers from initial gap assessment to regulatory inspection readiness. Our services cover GMP documentation and SOP development, facility and process compliance, staff training, internal audits, corrective action implementation, and full support for PPB and KEBS inspections in line with WHO GMP requirements. With strong local regulatory understanding and practical implementation expertise, Vertex supports organizations across major Kenyan cities including Nairobi, Mombasa, Kisumu, Nakuru, Eldoret, Thika, Machakos, Naivasha, and Nyeri, ensuring faster approvals, sustainable compliance, and export-ready GMP systems.​

Introduction to GMP Certification in Kenya

Good Manufacturing Practices (GMP) form a critical framework for ensuring product quality, safety, and regulatory compliance across various sectors in Kenya. The Pharmacy and Poisons Board (PPB) oversees pharmaceuticals, medical products, and health technologies, enforcing guidelines aligned with WHO standards to prevent contamination and ensure efficacy. These bodies collaborate to align with regional East African Community (EAC) requirements, promoting harmonized GMP inspections for medicinal products. For Kenyan businesses, GMP certification mitigates risks like recalls, builds consumer trust, and supports export readiness to markets demanding WHO or PIC/S compliance. With PPB’s recent updates to GMP guidelines in 2025, manufacturers must prioritize adherence to stay competitive

What is GMP Certification?

Good Manufacturing Practice (GMP) is a system of standards that ensures products are consistently produced and controlled according to quality and safety requirements. GMP focuses on minimizing risks involved in manufacturing processes that cannot be eliminated through final product testing alone.

GMP certification demonstrates that an organization has implemented robust systems covering:

• Controlled manufacturing environments

• Qualified personnel and training

• Validated processes and equipment

• Proper documentation and record-keeping

• Effective quality control and assurance

GMP is not a product certification but a process-based compliance framework that governs how products are manufactured, tested, stored, and distributed. In Kenya, GMP compliance is mandatory for regulated sectors and often a prerequisite for licensing and product registration.

Who Needs GMP Certification?

Pharmaceutical manufacturers rely on GMP to validate drug production processes and ensure patient safety. Food and beverage processors use it to maintain hygiene and prevent spoilage in handling and storage. Cosmetics and personal care makers implement GMP for clean formulation and stable shelf-life products.

Medical device producers and herbal/nutraceutical companies also benefit, safeguarding functionality and purity. Any operation aiming for quality excellence finds GMP indispensable for operational integrity

Step by Step Procedure to get GMP Certification in Kenya:

GMP Certification Process in Kenya

The GMP certification process in Kenya follows a structured and systematic approach:

Step 1: GMP Gap Assessment

A detailed assessment of existing processes, facilities, and documentation against Kenyan GMP and WHO GMP requirements to identify gaps and risks.

Step 2: Documentation and SOP Development

Preparation of GMP-compliant:

• Quality manuals

• SOPs and policies

• Formats and records

• Validation and qualification protocols

Step 3: Implementation and Training

Rolling out GMP systems across departments, supported by role-based training to ensure staff understand and follow GMP requirements in daily operations.

Step 4: Internal Audits and Corrective Actions

Conducting GMP internal audits to verify implementation effectiveness, followed by closure of identified non-conformities.

Step 5: Regulatory Inspection and Approval

Preparation for and support during PPB or KEBS inspections, including response to observations and corrective action submissions.

Once compliance is demonstrated, the organization is granted GMP approval or certification, subject to ongoing surveillance and periodic inspections.

Who Needs GMP Certification in Kenya?

GMP certification is essential or strongly recommended for a wide range of industries in Kenya, including:

Pharmaceutical Manufacturers

• Finished dosage forms

• APIs and intermediates

• Contract manufacturing organizations (CMOs)

Food and Beverage Processing Units

• Packaged food manufacturers

• Dairy and meat processing facilities

• Beverage, bottled water, and nutraceutical producers

Cosmetics and Personal Care Manufacturers

• Skincare and haircare products

• Toiletries and hygiene products

Medical Device Manufacturers

• Disposable and reusable devices

• Diagnostic kits and accessories

Herbal, Nutraceutical, and Supplement Producers

• Traditional medicine manufacturers

• Herbal extracts and dietary supplements

For many of these sectors, GMP compliance is a legal requirement for licensing, while for others it is essential for customer trust, exports, and brand reputation.