🇱🇾 ValiPro: NCDCR & WHO GMP Process Validation Services

Achieve Compliance and Secure Product Registration with Libya's National Centre for Drug Control and Research (NCDCR).

ValiPro provides expert Process Validation Protocol and Report services tailored for manufacturers targeting the Libyan market. Our documentation is built for full compliance with the requirements of the National Centre for Drug Control and Research (NCDCR), the central regulatory body, which strongly enforces WHO Good Manufacturing Practices (WHO GMP) Guidelines and other recognized international standards for imported medicines.

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

🌟 Why NCDCR-Ready Validation is Crucial

The NCDCR is the regulatory body responsible for drug control, registration, and quality assurance in Libya. Compliance with their standards is mandatory for market entry.

• WHO GMP Reliance: The NCDCR regulatory framework primarily adopts and enforces WHO GMP guidelines. This means your validation documentation must align with WHO's expectations for quality systems and process control (e.g., WHO TRS Annex 3).

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

• GMP Certificate Verification: Foreign manufacturers must provide documents demonstrating GMP compliance and product quality. Our robust, internationally-aligned validation documentation is essential evidence for demonstrating a state of control during the NCDCR's assessment process.

🎯 NCDCR Compliance Focus: Who We Support

We work closely with manufacturers and their local agents in Libya who need:

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

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

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

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

🛠️ Our NCDCR Process Validation Services

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

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

📜 Regulatory Standards We Follow

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

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

• ICH Q8, Q9, Q10: Alignment with these global principles ensures that the process lifecycle approach is acceptable, demonstrating a modern, risk-based approach to validation.

• EU/US FDA Standards: Used as reference standards for advanced technical depth and robustness, which aids in gaining NCDCR regulatory confidence.

🤝 Get Started on Your NCDCR Validation

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

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

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

• Target NCDCR 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 NCDCR deficiency letters.