🇬🇾 ValiPro: GA-FDD, WHO GMP & Quality Documentation Services for Guyana

Secure Drug Registration in Guyana by Meeting the GA-FDD's Technical Requirements and Demonstrating Compliance with International GMP Standards.

ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers targeting the Guyanese market. Our documentation is built for full compliance with the rigorous standards enforced by the GA-FDD.

Key compliance pillars include:

• Adherence to Good Manufacturing Practice (GMP) standards as the scientific foundation for drug quality.

• The requirement for detailed quality documentation to support the safety and efficacy of the product.

• Alignment with international best practices through collaboration with PAHO and the WHO Certification Scheme.

🌟 Why GA-FDD Validation is Crucial

The GA-FDD's drug registration process requires a thorough evaluation of the drug's quality, which is based on the manufacturer's control over the production process. Your validation reports are the scientific evidence for this control.

• Legal Basis (Food and Drugs Act): The Food and Drugs Act prohibits the sale of any drug that was manufactured, prepared, packed, or stored under insanitary conditions or that is adulterated (Section 9). Process Validation directly proves that the product is consistently produced under controlled, sanitary conditions and meets its quality specifications.

• GMP Compliance: The GA-FDD requires compliance with Good Manufacturing Practice (GMP) guidelines. While local manufacturers must meet these standards, international exporters must provide a GMP Certificate from the country of origin. This certificate is scientifically supported by detailed quality documentation, including Process Validation and Cleaning Validation reports, which must be auditable.

• Prescribed Standards: The Regulations prescribe the standards of composition, strength, potency, purity, quality, or other property of a drug (Regulation 3). Process validation demonstrates how the manufacturing process ensures these standards are consistently met.

• Drug Certificate and Registration: All pharmaceutical products must be registered with the GA-FDD before importation and sale. The registration dossier must include:

  • Scientific data submitted (e.g., clinical trial data).

  • Manufacturing Processes and control methods.

  • Labeling information.

• Quality Control Testing: The GA-FDD includes quality control protocols and testing as part of its regulatory measures. Clear, validated analytical methods are necessary to support any testing the department may perform to verify product integrity.

🎯 Compliance Focus: Who We Support

We work with international manufacturers targeting the Guyanese market:

• Pharmaceutical Exporters: Targeting the initial drug registration process with the GA-FDD.

• Quality Documentation Review: Firms needing to ensure their quality documentation aligns with the principles of the WHO Certification Scheme and other international best practices referenced by the GA-FDD.

• GMP Support: Companies needing validation documentation that is robust enough to support their foreign GMP Certificate during the GA-FDD's evaluation.

🛠️ Our Process Validation Services for Guyana

We provide complete, scientifically sound, and document-intensive support tailored to the GA-FDD's technical requirements.

ServiceGuyana / GA-FDD / WHO GMP FocusPVP & PVR PreparationProtocols and reports aligned with WHO/ICH GMP principles, demonstrating control over all critical manufacturing parameters.Analytical Method Validation (AMV)Preparation of detailed AMV reports for all analytical methods used for Quality Control, ensuring the methods are reliable and auditable for the GA-FDD.Quality Dossier StructuringOrganizing the manufacturing process descriptions, specifications, and control methods for submission, ensuring they directly address the requirements of the Food and Drugs Act regarding safety and sanitary conditions.Document ReviewReviewing existing quality documentation (CoPP, GMP Certificates) to ensure the supporting validation data is consistent and complete.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards adopted and enforced by the GA-FDD:

• The Food and Drugs Act (Cap. 34:03): The primary legal framework.

• WHO GMP Guidelines: The underlying international benchmark for manufacturing practice compliance.

• International Pharmacopoeias (e.g., USP, Ph. Eur., BP): Used as references for quality testing and specifications.

🤝 Get Started on Your Guyana Validation

Ensure your process validation documentation is robust, meets international quality standards, and is immediately acceptable to the GA-FDD, securing your necessary approvals and market access in Guyana.

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

• Product: Dosage form (e.g., solid oral, injectable, API) and Batch Size

• Target Status: New Registration

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission date

• Existing Data: Any current validation documents or GA-FDD queries.