🇿🇦 ValiPro: SAHPRA GMP Validation and Registration Services
Ensure Validation Documentation Meets SAHPRA's PIC/S and ICH-Aligned Standards to Accelerate Marketing Authorization and Pass Mandatory On-site Inspections.
ValiPro provides expert Process Validation Protocol and Report services specifically designed to meet the rigorous quality standards required by SAHPRA for both locally manufactured and imported medicines.
Key compliance pillars for South African market entry and manufacturing include:
Central Authority (SAHPRA): Responsible for registration, licensing (manufacturing/import/wholesale), and enforcing compliance with the Medicines and Related Substances Act (Act 101 of 1965).
GMP Standard: SAHPRA has fully adopted the PIC/S Guide to Good Manufacturing Practice for Medicines (PE 009). This includes Chapter 5 (Production) and Annex 15 (Qualification and Validation), making validation a central requirement for all sites.
ICH Alignment: SAHPRA aligns its quality guidelines (Quality, Bioequivalence) with those of the European Medicines Agency (EMA) and the International Council for Harmonisation (ICH). This includes adopting the ICH Q7 guideline for Active Pharmaceutical Ingredients (APIs).
Dossier Submission: All applications must be submitted in the Common Technical Document (CTD) or electronic CTD (eCTD) format, where validation data resides in Module 3 (Quality/CMC).
🌟 Why Validation is Crucial for SAHPRA Compliance
For both local and foreign manufacturers, comprehensive validation is non-negotiable for obtaining a license and product registration in South Africa.
1. GMP Licensing and PIC/S Requirements
Any site manufacturing, packaging, or conducting quality control for medicines registered in South Africa must hold a valid SAHPRA Manufacturer's or Importer's License and be compliant with the SA Guide to Good Manufacturing Practice for Medicines, which is the PIC/S Guide.
Qualification and Validation (PIC/S Annex 15): The GMP guide requires a Validation Master Plan (VMP) that details the policy for:
Qualification (DQ, IQ, OQ, PQ) of critical equipment and utilities (e.g., Water Systems, HVAC).
Process Validation (PV) for all critical manufacturing steps.
Cleaning Validation to prevent cross-contamination.
Analytical Method Validation (AMV) for all in-house test methods.
Process Validation Lifecycle: SAHPRA follows the modern, lifecycle approach, requiring evidence of Process Design, Process Performance Qualification (PPQ), and ongoing Continued Process Verification (CPV).
2. Marketing Authorization (Registration)
Validation reports are submitted as evidence within the Quality Module of the registration dossier.
Module 3 (Quality): The Chemistry, Manufacturing, and Controls (CMC) section requires documentation to demonstrate that the manufacturing process is robust and controlled.
3.2.P.3 (Manufacture): Requires a description of the manufacturing process supported by Process Validation data.
3.2.P.5 (Control of Finished Product): Requires Analytical Method Validation data to support the reliability of release testing.
API Validation: For APIs, compliance with ICH Q7 (which SAHPRA has adopted) requires rigorous API Process Validation and Cleaning Validation.
3. Regulatory Reliance and Audit Preparedness
SAHPRA has an active Reliance Guideline, leveraging assessments from other Recognized Regulatory Authorities (RRAs) (e.g., US FDA, EMA, Health Canada) to streamline its review process.
Alignment with RRA Dossiers: If a drug is already approved by an RRA, the validation documentation should be identical and of the same standard (ICH/PIC/S), which facilitates the abridged review pathway.
SAHPRA Inspections: SAHPRA conducts regular on-site GMP audits of local facilities and may also inspect foreign manufacturers. The auditor's checklist is based on the PIC/S GMP Guide, with a heavy focus on the completeness and execution of the validation protocols and reports.
🎯 Compliance Focus: Who We Support
We work with manufacturers targeting the South African market:
Foreign Manufacturers (Importers): Requiring validation dossiers to meet the stringent SAHPRA/PIC/S requirements for their Manufacturing License and Import Drug Registration (Module 3 submission).
Local Manufacturers: Needing comprehensive VMPs and execution of Qualification/Validation protocols to pass SAHPRA's mandatory GMP inspections.
Generic Drug Applicants (ANDA): Requiring robust Analytical Method Validation and Process Validation data to support the quality claims accompanying the Bioequivalence (BE) study in the registration dossier.
🛠️ Our Process Validation Services for SAHPRA
We provide complete, scientifically sound, and internationally aligned validation documentation ready for SAHPRA submission and audit defense.
ServiceSAHPRA / PIC/S / ICH FocusPIC/S VMP & PVDevelopment of a Validation Master Plan (VMP) and Process Performance Qualification (PPQ) protocols aligned with PIC/S Annex 15.ICH Q7/API ValidationSpecialized validation for API manufacturers, including strict Cleaning Validation and Change Control Validation documentation as per ICH Q7.Utility & Equipment QualificationFull lifecycle Qualification (DQ, IQ, OQ, PQ) for critical systems (Water, HVAC, Sterilizers), documented according to PIC/S standards.Module 3 Technical SupportStructuring and organizing validation summaries and data for inclusion in eCTD Module 3 to pass the SAHPRA screening and scientific assessment.
🤝 Next Step: Secure SAHPRA Validation Readiness
Ensure your validation documentation is robust, aligns with the adopted PIC/S and ICH guidelines, and is ready to support your SAHPRA registration and GMP license application.
To receive a Technical Scope and Commercial Proposal tailored for your South African market entry or local manufacturing project, simply provide:
Product: Active Pharmaceutical Ingredient (API) or Finished Formulation (e.g., tablet, injectable)
Application Type: New Registration / Generic (BE) Submission / License Renewal
Manufacturing Site Status: Local SA Site / Foreign Importer Site
Timeline: Target submission date for SAHPRA