🇰🇪 ValiPro: PPB, WHO GMP & PIC/S Process Validation Services

Achieve Compliance and Secure Product Registration with Kenya's Pharmacy and Poisons Board (PPB).

ValiPro provides expert Process Validation Protocol and Report services tailored for manufacturers targeting the significant Kenyan market, a major hub in East Africa. Our documentation is built for full compliance with the rigorous standards of the Pharmacy and Poisons Board (PPB), the central regulatory body, which strongly adheres to WHO Good Manufacturing Practices (WHO GMP) Guidelines and is aligned with PIC/S principles and EAC harmonization efforts.

We specialize in supporting manufacturers of human and veterinary medicines, APIs, and medical devices, ensuring their validation packages secure timely PPB approvals, minimize review deficiencies, and facilitate product registration in Kenya and the wider East African Community region.

🌟 Why PPB-Ready Validation is Crucial

The Pharmacy and Poisons Board (PPB) regulates all aspects of pharmaceutical products in Kenya. Compliance with their standards is mandatory for market entry and is strictly aligned with international and regional best practices.

• WHO/PIC/S GMP Mandate: The PPB enforces GMP standards that closely follow the WHO Technical Report Series (TRS) and adopts principles aligned with PIC/S. Your process validation documentation must conform precisely to these detailed international standards (e.g., WHO TRS Annex 3).

• EAC Harmonization: Kenya is a leading member of the East African Community (EAC). Submissions are often structured according to the EAC Common Technical Document (CTD) format, requiring validation data to be correctly presented in the Quality Module.

• GMP Inspection: Foreign manufacturing sites must hold a valid GMP certificate recognized by the PPB, often necessitating an inspection or desk review. Our robust, internationally-aligned validation documentation is essential evidence for demonstrating a state of control.

🎯 PPB Compliance Focus: Who We Support

We work closely with manufacturers and their local representatives in Kenya who need:

• Pharmaceutical Exporters: Targeting human and veterinary drug registration with the PPB.

• GMP Conformance: Overseas facilities seeking PPB recognition of their GMP status (based on WHO/PIC/S GMP).

• EAC CTD Quality Module: Preparation of the Quality Module ensuring that all manufacturing and control data, including validation, meets EAC/PPB expectations.

• Regulatory Responses: Firms addressing technical deficiencies or quality queries issued by PPB assessors regarding manufacturing process controls and capability.

🛠️ Our PPB Process Validation Services

We provide complete, scientifically sound, and document-intensive support to meet the PPB's expectations for WHO/PIC/S-aligned quality data.

ServicePPB / EAC / WHO / PIC/S FocusPVP & PVR PreparationCustom protocols and reports aligned with WHO GMP (TRS) / PIC/S principles, detailing the process validation lifecycle (Design, Qualification, Continuous Verification).Dossier IntegrationStructuring validation summaries and data precisely for the EAC CTD format (Quality Module) required by the PPB.GMP Gap AssessmentReviewing your current validation documents and procedures against the stringent WHO GMP and PIC/S standards adopted by the PPB.Technical Defense & Query HandlingProviding expert technical defense and drafting precise responses to PPB assessors, ensuring queries are resolved quickly and effectively.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards adopted and enforced by the Pharmacy and Poisons Board:

• WHO Technical Report Series (TRS): The primary benchmark for GMP and validation compliance in Kenya.

• PIC/S GMP Guide: Principles and annexes are heavily relied upon for facility quality and control.

• EAC Common Technical Document (CTD) Guidelines: Compliance with regional harmonization efforts for dossier structure.

• ICH Q8, Q9, Q10: Alignment with these global principles supports the modern, risk-based approach to validation favored by the PPB.

🤝 Get Started on Your PPB Validation

Ensure your process validation documentation is robust and immediately acceptable to the PPB, securing your necessary approvals and market access in Kenya and the EAC.

To receive a Technical Scope and Commercial Proposal tailored for your PPB project, simply provide:

• Product: Dosage form (e.g., solid oral, injectable, API) and Batch Size

• Target PPB Status: Product Registration / GMP Compliance Check (New or Renewal)

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission or inspection date

• Existing Data: Any current validation documents or PPB deficiency letters.