🇱🇰 ValiPro: NMRA & WHO GMP Process Validation Services
I will adapt the ValiPro content to create a focused webpage specifically targeting manufacturers exporting to Sri Lanka, emphasizing compliance with the National Medicines Regulatory Authority (NMRA) regulations, their reliance on WHO GMP, and the specific documentation requirements.
Here is the proposed webpage structure:
🇱🇰 ValiPro: NMRA & WHO GMP Process Validation Services
Secure NMRA Approval and Seamlessly Register Your Products in Sri Lanka.
ValiPro provides expert Process Validation Protocol and Report services tailored for local and overseas manufacturers targeting the Sri Lankan market. Our documentation ensures full alignment with the requirements of the National Medicines Regulatory Authority (NMRA) and its adopted standards, primarily the WHO Good Manufacturing Practices (GMP) Guidelines.
We specialize in supporting manufacturers of Medicines, Medical Devices, Borderline Products, and Cosmetics, helping them achieve NMRA site approvals, minimize review deficiencies, and expedite product registration.
🌟 Why NMRA-Ready Validation is Crucial
The NMRA Act of 2015 and subsequent regulations govern all medicinal products in Sri Lanka. The NMRA mandates that all manufacturing sites adhere to globally recognized GMP, specifically adopting WHO GMP guidelines.
WHO GMP Compliance: The NMRA's core regulatory principle is conformance to WHO GMP. WHO Annex 3 on Validation is the fundamental standard for your process validation documentation.
Dossier Requirements: The registration process requires the submission of a Product Dossier (PD). For relevant products (e.g., Borderline Products), the dossier specifically requests the "Manufacturing process validation report for three consecutive commercial batches (If applicable only)."
Site Approval Prerequisite: Approval of the manufacturing site (local or foreign) is mandatory before product registration. Our validation reports form a critical part of the Site Master File (SMF) and overall quality system reviewed during desk reviews and required GMP audits.
🎯 NMRA Compliance Focus: Who We Support
We support manufacturers and their local authorized agents in Sri Lanka who require:
Foreign Manufacturers: Seeking NMRA Site Approval and subsequent product Marketing Authorization for medicines and medical devices.
Local Manufacturers: Navigating the multi-stage licensing process, from formulation approval to commercial batch GMP approval.
Products Requiring NMQAL Approval: Ensuring that in-house analytical method Validation Reports are submitted and approved by the National Medicines Quality Assurance Laboratory (NMQAL).
Regulatory Responses: Addressing quality, CMC, and GMP queries raised by NMRA assessors.
🛠️ Our NMRA Process Validation Services
We provide complete, document-intensive support to meet NMRA's specific expectations for quality and manufacturing data.
ServiceNMRA FocusPVP & PVR PreparationCustom protocols and reports structured to address WHO GMP (TRS) validation principles, including the 3-batch requirement for certain products.Analytical ValidationPreparation of detailed Analytical Method Validation Reports for drug products, mandatory for submission to NMQAL.NMRA Dossier IntegrationStructuring validation data to fit the NMRA's Product Dossier (PD) format (Module 3 - Quality), or the CTD/ACTD structure where applicable, for seamless submission.Site Master File (SMF) SupportEnsuring the validation summary within the SMF aligns with the WHO Annex 14 / PIC/S PE 008-4 requirements.Gap AssessmentReviewing current procedures against the NMRA Guideline on Good Manufacturing Practices (which adopts WHO GMP).
📜 Regulatory Standards We Follow
Our documentation is engineered to align with the stringent standards relied upon by the National Medicines Regulatory Authority:
WHO Technical Report Series (TRS): The primary benchmark for GMP compliance in Sri Lanka (NMRA Act, 2015).
NMRA GMP Guideline (GL-022): Adopts and enforces WHO GMP, including the principles of validation found in WHO TRS Annex 3.
ICH Q8, Q9, Q10: Alignment with these global principles ensures that the process lifecycle approach is acceptable, especially where documentation may be submitted in the CTD format (NMRA accepts CTD/ACTD in some cases).
PIC/S Requirements: Used as a reference for drafting quality documents like the Site Master File (SMF).
🤝 Get Started on Your NMRA Validation
Ensure your process validation documentation is robust and immediately acceptable to the NMRA, avoiding costly delays in manufacturing site approval and product registration.
To receive a Technical Scope and Commercial Proposal tailored for your NMRA project, simply provide:
Product: Dosage form (e.g., tablet, injectable, herbal extract) and Batch Size
Target NMRA Product Category: (e.g., Medicine, Borderline Product, Medical Device)
Target Status: Site Approval / Product Registration (New or Renewal)
Timeline: Submission or inspection date
Existing Data: Any current validation documents or NMRA deficiency letters.