🇸🇱 ValiPro: PBSL, WHO GMP & ECOWAS Process Validation Services

Achieve Compliance and Secure Product Registration with the Pharmacy Board of Sierra Leone (PBSL).

ValiPro provides expert Process Validation Protocol and Report services tailored for manufacturers targeting the market in Sierra Leone. Our documentation is built for full compliance with the rigorous standards of the Pharmacy Board of Sierra Leone (PBSL), the central regulatory authority, which strongly adheres to WHO Good Manufacturing Practices (WHO GMP) Guidelines and the regional harmonization efforts of ECOWAS/WAHO.

We specialize in supporting manufacturers of human and veterinary medicines, APIs, and allied products, ensuring their validation packages secure timely PBSL approvals, minimize review deficiencies, and facilitate product registration in Sierra Leone and the wider West African region.

🌟 Why PBSL-Ready Validation is Crucial

The PBSL regulates all aspects of medicines and health products in Sierra Leone. Compliance with their standards is mandatory for market entry and is strictly aligned with international best practices.

• WHO GMP Mandate: The PBSL enforces GMP standards that closely follow the WHO Technical Report Series (TRS). Your process validation documentation must conform precisely to these detailed international standards (e.g., WHO TRS Annex 3).

• ECOWAS/WAHO Alignment: Sierra Leone is a member of the Economic Community of West African States (ECOWAS) and its health arm, WAHO. Dossier submissions are moving toward regional harmonization, often favoring the Common Technical Document (CTD) structure.

• Dossier Quality: Product registration requires the submission of a comprehensive technical dossier. Validation reports for critical processes (manufacturing, cleaning, analytical methods) are a crucial part of the Quality Module reviewed by the PBSL.

• Importation Permit: Foreign manufacturing sites must demonstrate compliance with recognized international GMP standards (backed by robust validation data) to obtain authorization for importation.

🎯 PBSL Compliance Focus: Who We Support

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

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

• GMP Conformance: Overseas facilities seeking PBSL recognition of their GMP status (based on WHO GMP).

• Dossier Quality: Preparation of the Quality Module ensuring that all manufacturing and control data, including validation, meets PBSL expectations.

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

🛠️ Our PBSL Process Validation Services

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

ServicePBSL / WHO / ECOWAS FocusPVP & PVR PreparationCustom protocols and reports aligned with WHO GMP (TRS), detailing the process validation lifecycle (Design, Qualification, Continuous Verification).Dossier IntegrationStructuring validation summaries and data precisely for the PBSL's required submission format for the Quality Module (often WHO or CTD-based).WHO GMP Gap AssessmentReviewing your current validation documents and procedures against the stringent WHO GMP standards adopted by the PBSL.Technical Defense & Query HandlingProviding expert technical defense and drafting precise responses to PBSL 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 Board of Sierra Leone:

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

• ECOWAS/WAHO Harmonization Principles: Alignment with regional efforts to standardize drug registration dossiers.

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

🤝 Get Started on Your PBSL Validation

Ensure your process validation documentation is robust and immediately acceptable to the PBSL, securing your necessary approvals and market access in Sierra Leone.

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

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

• Target PBSL 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 PBSL deficiency letters.