🇧🇼 ValiPro: BOMRA & WHO GMP Process Validation Services

Achieve Compliance and Secure Product Registration with Botswana's Regulatory Authority (BOMRA).

ValiPro provides expert Process Validation Protocol and Report services tailored for manufacturers targeting the market in Botswana. Our documentation is built for full compliance with the requirements of the Botswana Medicines Regulatory Authority (BOMRA), which strongly enforces WHO Good Manufacturing Practices (GMP) Guidelines and other recognized international standards, particularly those aligned with the Southern African Development Community (SADC) and PIC/S.

We specialize in supporting manufacturers of human medicines, APIs, and medical supplies, ensuring their validation packages secure timely BOMRA approvals, minimize review deficiencies, and facilitate product registration in Botswana.

🌟 Why BOMRA-Ready Validation is Crucial

The Botswana Medicines Regulatory Authority (BOMRA) is the statutory body responsible for regulating all medicines and medical devices in the country. Meeting their standards is mandatory for market entry.

• WHO/PIC/S GMP Reliance: BOMRA's regulatory framework adopts and enforces internationally recognized GMP standards, primarily WHO GMP Guidelines and principles derived from PIC/S. Your validation documentation must align with these detailed expectations (e.g., WHO TRS Annex 3).

• Dossier Requirement: Product registration requires the submission of a comprehensive dossier, often based on the CTD (Common Technical Document) format. Validation reports for critical processes (manufacturing, cleaning, analytical methods) are a crucial part of the Quality Module reviewed by BOMRA.

• GMP Assessment: Foreign manufacturers must provide valid GMP certification from a recognized authority. Our robust, internationally-aligned validation documentation is essential evidence for demonstrating a state of control during the BOMRA's assessment process.

🎯 BOMRA Compliance Focus: Who We Support

We work closely with manufacturers and their local representatives in Botswana who need compliance with the following:

• Pharmaceutical Exporters: Targeting human drug and API registration with BOMRA.

• GMP Conformance: Manufacturers requiring documented evidence of WHO/PIC/S GMP conformance for their entire manufacturing and control systems.

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

• Regulatory Responses: Firms addressing deficiency letters or quality queries issued by BOMRA assessors regarding manufacturing process controls and capability.

🛠️ Our BOMRA Process Validation Services

We provide complete, scientifically sound, and document-intensive support to meet the BOMRA's expectations for quality data and process control.

ServiceBOMRA / WHO / PIC/S FocusPVP & PVR PreparationCustom protocols and reports structured to address WHO GMP (TRS) / PIC/S validation principles, including the demonstration of process capability and robustness.Analytical ValidationPreparation of detailed Analytical Method Validation Reports to ensure testing procedures meet international standards for quality control.Dossier IntegrationStructuring validation data to be easily incorporated into the BOMRA's required submission format for the Quality Module (often CTD/WHO-based).Gap AssessmentReviewing current validation procedures against the adopted WHO GMP and relevant international guidelines.Query HandlingProviding expert technical defense and drafting responses to quality and validation queries from BOMRA assessors.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards prioritized by BOMRA:

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

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

• ICH Q8, Q9, Q10: Alignment with these global principles ensures that the process lifecycle approach is acceptable.

• SADC Guidelines: Awareness of regulatory best practices from the Southern African Development Community (SADC) region.

🤝 Get Started on Your BOMRA Validation

Ensure your process validation documentation is robust and immediately acceptable to BOMRA, securing your necessary approvals and market access in Botswana.

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

• Product: Dosage form (e.g., tablet, injectable) and Batch Size

• Target BOMRA Category: (e.g., Human Drug, API, Medical Device)

• Target Status: New Registration / Renewal / GMP Compliance Check

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission or inspection date

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