🇩🇿 ValiPro: ANPP, EU & WHO GMP Process Validation Services
Secure Registration and Market Access in Algeria with Globally Compliant Documentation.
ValiPro provides expert Process Validation Protocol and Report services tailored for manufacturers targeting the Algerian market. Our documentation is built for full compliance with the rigorous standards of the National Agency of Pharmaceutical Products (ANPP), which relies on the strict principles of EU GMP and WHO GMP Guidelines for pharmaceutical product quality.
We specialize in supporting manufacturers of human and veterinary medicines, APIs, and medical supplies, ensuring their validation packages secure timely ANPP approvals, minimize deficiency letters, and facilitate the essential GMP assessment for foreign sites.
🌟 Why ANPP-Ready Validation is Crucial
The ANPP, under the Algerian Ministry of Health, is the primary authority regulating pharmaceutical products. Compliance with their standards, which are heavily influenced by European and international benchmarks, is mandatory for importation and sale.
EU/WHO GMP Mandate: The ANPP enforces GMP standards that closely follow the EU GMP Guidelines and the WHO Technical Report Series (TRS). Your validation documentation must align with these detailed international standards.
Dossier Requirement: Product registration in Algeria requires the submission of a comprehensive dossier, often utilizing the CTD (Common Technical Document) format. Validation reports for critical processes (manufacturing, cleaning) must be correctly presented in Module 3 (Quality).
GMP Assessment: Foreign manufacturing sites must undergo a rigorous GMP inspection or assessment conducted/reviewed by the ANPP. Our robust, EU/WHO-aligned validation documents are crucial evidence to demonstrate the facility's state of control.
🎯 ANPP Compliance Focus: Who We Support
We work closely with manufacturers and their local representatives in Algeria who need compliance with the following:
Pharmaceutical Exporters: Targeting registration for human and veterinary drugs with the ANPP.
GMP Conformance: Overseas facilities seeking ANPP recognition or certification of their GMP status (based on EU/WHO principles).
CTD Module 3 Quality: Preparation of the S.2.5 (Process Validation) and P.3.4 (Process Validation) sections of the CTD, including all necessary protocols and reports.
Regulatory Responses: Firms addressing technical deficiencies or quality queries issued by ANPP assessors regarding manufacturing process controls and capability.
🛠️ Our ANPP Process Validation Services
We provide complete, scientifically sound, and document-intensive support to meet the ANPP's expectations for EU/WHO-aligned quality data.
ServiceANPP / EU / WHO FocusPVP & PVR PreparationCustom protocols and reports aligned with the EU GMP Annex 15 and WHO GMP (TRS), detailing the process lifecycle (Design, Qualification, Verification).CTD Module 3 StructureStructuring and presenting validation summaries and data precisely for CTD Module 3 to ensure technical and structural compliance for ANPP review.EU/WHO GMP Gap AssessmentReviewing your current validation documents and procedures against the stringent EU GMP Annex 15 and relevant WHO GMP standards adopted by the ANPP.Technical Defense & Query HandlingProviding expert technical defense and drafting precise responses to ANPP 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 National Agency of Pharmaceutical Products:
EU GMP Guidelines & Annexes: The primary benchmark for pharmaceutical manufacturing quality and validation (Annex 15).
WHO Technical Report Series (TRS): Used as a foundational standard for GMP and validation compliance.
ICH Q8, Q9, Q10: Alignment with these global principles, which supports the modern, risk-based approach to validation favored by the ANPP.
Common Technical Document (CTD): The required submission format for product registration applications.
🤝 Get Started on Your ANPP Validation
Ensure your process validation documentation is robust and immediately acceptable to the ANPP, securing your necessary GMP certification and product registration in Algeria.
To receive a Technical Scope and Commercial Proposal tailored for your ANPP project, simply provide:
Product: Dosage form (e.g., solid oral, injectable, API) and Batch Size
Target ANPP Status: Product Registration / GMP Certification (New or Renewal)
Manufacturing Process: Overview of critical steps and control strategy
Timeline: Submission or inspection date
Existing Data: Any current validation documents or ANPP deficiency letters.