š¹š· ValiPro: TÄ°TCK & EU GMP Process Validation Services
Achieve Swift Approval and Market Entry in Turkey with EU-Aligned Validation Documentation.
ValiPro provides expert Process Validation Protocol and Report services tailored for manufacturers targeting the Turkish market. Our documentation is built for full compliance with the rigorous standards of the Turkish Medicines and Medical Devices Agency (TÄ°TCK), which strictly adheres to the European Union Good Manufacturing Practices (EU GMP) guidelines.
We specialize in supporting manufacturers of Pharmaceuticals, Biologics, APIs, and Medical Devices, ensuring their validation packages secure timely TÄ°TCK approvals, minimize deficiency letters, and support the mandatory GMP Inspection process for foreign sites.
š Why TÄ°TCK (EU GMP)-Ready Validation is Crucial
Turkey, a major pharmaceutical market and candidate for EU membership, closely follows European regulatory standards. Meeting TÄ°TCK requirements means meeting the EU's expectations.
EU GMP Mandate: TÄ°TCK has officially adopted EU GMP Guidelines (including Annex 15 on Qualification and Validation). Your process validation must conform precisely to these detailed European standards.
CTD Submission Format: Drug registration dossiers must follow the Common Technical Document (CTD) format. We ensure your validation reports are correctly presented in Module 3 (Quality), aligning with the EU structure required by TÄ°TCK.
GMP Inspection: Foreign sites must undergo or provide proof of GMP compliance. Our EU-aligned validation documentation is crucial evidence for demonstrating a state of control during the TÄ°TCK's GMP inspection or desk review.
šÆ TÄ°TCK Compliance Focus: Who We Support
We work closely with manufacturers and their local representatives in Turkey who need:
Pharmaceutical Exporters: Targeting human and veterinary drug registration with TÄ°TCK using the CTD format.
EU GMP Conformance: Overseas facilities seeking TÄ°TCK GMP Certification (which relies on EU GMP).
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 reports and protocols.
Regulatory Responses: Firms addressing technical deficiencies or quality queries issued by TÄ°TCK assessors regarding manufacturing process controls and capability.
š ļø Our TÄ°TCK Process Validation Services
We provide complete, scientifically sound, and document-intensive support to meet TÄ°TCK's specific expectations for EU-aligned quality data.
ServiceTÄ°TCK / EU FocusPVP & PVR PreparationCustom protocols and reports aligned with the EU GMP Annex 15 and the ICH Q-series principles (Process Design, Qualification, Continuous Verification).CTD Module 3 StructureStructuring and presenting validation summaries and data precisely for CTD Module 3 to ensure technical and structural compliance.EU GMP Gap AssessmentReviewing your current validation documents and procedures against the stringent EU GMP Annex 15 and relevant TÄ°TCK guidance.Technical Defense & Query HandlingProviding expert technical defense and drafting responses to TÄ°TCK assessors, ensuring queries are resolved quickly and thoroughly.
š Regulatory Standards We Follow
Our documentation is engineered to align with the core standards adopted and enforced by the Turkish Medicines and Medical Devices Agency:
EU GMP Guidelines & Annexes: The mandatory benchmark for all quality and validation processes (specifically Annex 15 on Qualification and Validation).
ICH Q8, Q9, Q10: Alignment with these global principles, which form the basis of the EU's lifecycle approach to validation and quality systems.
Common Technical Document (CTD): The required submission format for all drug registration applications.
Pharmaceutical Inspection Co-operation Scheme (PIC/S): Adherence to these principles, which are highly regarded by TÄ°TCK.
š¤ Get Started on Your TÄ°TCK Validation
Ensure your process validation documentation is robust and immediately acceptable to TÄ°TCK, securing your necessary GMP certification and product registration in Turkey.
To receive a Technical Scope and Commercial Proposal tailored for your TÄ°TCK project, simply provide:
Product: Dosage form (e.g., solid oral, injectable) and Batch Size
Target TÄ°TCK 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 TÄ°TCK deficiency letters.