TNV Inspection Services for Pharmaceuticals
The pharmaceutical industry is at the forefront of healthcare, developing medicines and medical devices that save lives and improve quality of life. Due to the critical nature of pharmaceutical products, the industry is subject to stringent regulatory requirements to ensure the safety, efficacy, and quality of these products. At TNV Division, we provide ISO 17020-accredited inspection services to pharmaceutical manufacturers and distributors, helping them maintain high-quality standards, regulatory compliance, and operational excellence.
Our independent and impartial inspections cover the entire lifecycle of pharmaceutical products, from raw material sourcing to production, packaging, and distribution. We are committed to supporting the pharmaceutical industry in delivering safe, effective, and high-quality products to the global market.
Our Pharmaceutical Inspection Services
We offer comprehensive inspection services for a wide range of pharmaceutical sectors, including but not limited to:
1. Manufacturing of Pharmaceutical Products
Good Manufacturing Practices (GMP) Compliance – Inspecting production facilities to ensure adherence to GMP guidelines, including sanitation, equipment calibration, and environmental control.
Batch Production & Quality Control – Verifying that batch production processes meet predefined specifications for quality, consistency, and regulatory standards.
Packaging & Labeling – Ensuring that packaging meets pharmaceutical standards, including tamper-evident seals, correct labeling, and regulatory compliance for market approval.
Storage & Distribution – Inspecting storage conditions and distribution channels for compliance with temperature, humidity, and other conditions critical to product integrity.
2. Active Pharmaceutical Ingredients (API)
Raw Material Inspection – Ensuring that raw materials used in the production of pharmaceutical products meet purity standards and quality specifications.
API Production Facilities – Conducting inspections of facilities that produce active pharmaceutical ingredients (APIs) to ensure GMP compliance and the safety of the production environment.
3. Pharmaceuticals for Human & Animal Use
Formulation & Dosage Inspections – Reviewing the formulation of medicines to ensure that active ingredients are correctly dosed, and the final product meets regulatory specifications.
Veterinary Pharmaceuticals – Inspecting the production processes and packaging of veterinary pharmaceuticals to ensure compliance with health and safety standards for animal medications.
4. Biotechnology and Biopharmaceuticals
Biopharmaceutical Production – Assessing the production of biologics, including monoclonal antibodies, vaccines, and gene therapies, for compliance with regulatory requirements and quality assurance.
Biotechnology Facilities – Inspecting the biotechnological production environment to ensure compliance with safety standards, sterile procedures, and environmental controls.
5. Pharmaceutical Packaging and Labeling
Tamper-Proof Packaging – Verifying that pharmaceutical products are packaged in tamper-evident materials and that the labeling meets international regulatory requirements.
Correct Information – Inspecting product labels to ensure they display accurate dosage, ingredients, manufacturing, and expiration information as per regulatory standards.
Key Areas We Cover
Our inspection services cover a wide range of areas to ensure your pharmaceutical products meet the highest standards:
Good Manufacturing Practices (GMP) Compliance – Inspecting manufacturing practices to ensure compliance with national and international GMP standards.
Raw Materials & API Inspections – Ensuring that raw materials and active pharmaceutical ingredients meet safety, quality, and regulatory standards.
Environmental Control & Sterility – Inspecting sterile production environments, air quality, and environmental controls to prevent contamination and ensure product safety.
Validation & Documentation – Verifying the validation of production processes, cleaning procedures, and calibration of equipment, as well as ensuring proper documentation and traceability.
Quality Control & Testing – Conducting inspections related to testing and quality control procedures, including microbiological testing, stability studies, and quality assurance protocols.
Supply Chain & Distribution – Ensuring that the entire pharmaceutical supply chain is compliant with international regulations, from raw material suppliers to distributors and retailers.
Regulatory Compliance – Ensuring compliance with local and international regulations, including FDA, EMA, WHO, and other relevant authorities for product approval and market access.
Inspection Methods & Activities
We follow a rigorous and evidence-based approach to conduct inspections in the pharmaceutical industry, ensuring that every stage of production, packaging, and distribution adheres to the highest standards:
1.Visual Inspections
On-site inspections of manufacturing facilities, storage areas, and packaging lines to ensure compliance with safety standards and GMP guidelines.
2.Sampling & Laboratory Testing
Collecting samples of raw materials, APIs, and finished pharmaceutical products for quality and safety testing in accredited laboratories. This includes tests for chemical composition, stability, sterility, and microbiological safety.
3.Process Audits
Conducting detailed audits of manufacturing processes, including production lines, equipment calibration, and validation procedures, to ensure that they meet GMP and regulatory requirements.
4.Environmental Monitoring
Assessing the cleanliness, air quality, and environmental conditions in production facilities, particularly in sterile areas, to minimize the risk of contamination.
5.Regulatory Compliance Checks
Reviewing labeling, packaging, and product documentation to ensure that they are fully compliant with regulatory standards set by authorities like the FDA, EMA, and other global regulatory bodies.
6.Supply Chain Audits
Verifying the integrity of the pharmaceutical supply chain, including supplier audits, transportation, and distribution channels, to ensure the safe and compliant movement of pharmaceutical products.
Cost of Inspection Services
The cost of pharmaceutical inspections depends on several factors, such as:
1.Scope of Inspection
The complexity of the inspection, including whether it involves GMP compliance, environmental controls, or specialized testing (e.g., sterility tests).
2.Inspection Type
Whether the inspection covers manufacturing, packaging, raw materials, or environmental controls, each area may require different levels of expertise and resources.
3.Location of Facility
The geographical location of your facility, which may affect travel costs and logistics.
4.Regulatory Requirements
Some inspections may require additional testing or documentation review to comply with specific regulatory standards or international guidelines.
At TNV Inspection Division, we provide tailored inspection services based on your unique needs. Contact us for a personalized quote that fits your business’s regulatory requirements, location, and the specific needs of your pharmaceutical operations.
How to Apply for Our Pharmaceutical Inspection Services
Applying for TNV Inspection Division pharmaceutical inspection services is straightforward:
Step 1: Submit an Inspection Request
Provide the following information:
Type of pharmaceutical inspection (e.g., GMP compliance, raw materials, packaging inspection)
Facility location
Scope and complexity of the inspection
Desired timeline
Step 2: Review & Quotation
Our experts will assess your requirements and send you a customized quote based on your inspection needs. This includes the inspection scope, cost estimate, and timeline.
Step 3: Inspection Scheduling
Once the quote is approved, we will schedule the inspection at your facility. Our certified inspectors will conduct on-site inspections and audits, following GMP guidelines and international regulatory requirements.
Step 4: Inspection Report
After the inspection, we will provide a comprehensive report detailing:
Compliance status
Identified issues or non-compliance areas
Recommendations for corrective actions
Step 5: Follow-up & Support
We offer follow-up inspections and ongoing support to help your facility maintain compliance and continuously improve its pharmaceutical production processes.
Contact Us
For expert, ISO 17020-accredited pharmaceutical inspection services, reach out to TNV Inspection Division today.
📩 Email:tnvindia@gmail.com
🌐 Website: www.tnvib.com
📍 Address: TNV House B-1/19/69 Sector K, Aliganj, Lucknow, UP 226024, India
Ensure safety, compliance, and quality in your pharmaceutical operations with TNV Inspection Division