Inside Fivevet’s Veterinary Drug Manufacturing Facility - From Raw Materials to Finished Products (Part I)

1. Incoming Raw Material Quality Control at Fivevet
The quality of incoming raw materials is an important factor that directly affects the quality and stability of finished products. At Fivevet, raw material control is part of the quality management system, helping ensure that materials used in manufacturing meet the applicable technical specifications.
Raw materials used in veterinary drug manufacturing include active ingredients and excipients, selected according to the formulation and characteristics of each dosage form. Raw material control focuses on the following areas:
- Checking raw material information and documentation: Verifying the material name, batch number, supplier, packaging condition, and accompanying quality documents.
- Controlling materials before use: Managing material status and carrying out sampling and testing according to the applicable procedures and specifications.
- Assessing raw material quality: Reviewing test results alongside the Certificate of Analysis (CoA) and other relevant quality information.
- Approving materials for production: Using materials only after they meet the required quality standards.
The supplier’s CoA is one of the documents used to assess raw material quality, but it does not replace all necessary control and testing activities.
Controlling raw materials from the start helps Fivevet establish a foundation for quality throughout the manufacturing process and maintain consistent quality standards across product batches.
2. Qualification, Validation, and Change Control
Alongside raw material quality, manufacturing equipment and processes play an important role in maintaining consistent quality across product batches.
At Fivevet, the facility is organized into dedicated production lines for non-beta-lactam veterinary drugs, beta-lactam veterinary drugs, viral vaccines, and bacterial vaccines. Separating production lines by product group helps control the specific technical requirements of each manufacturing process.
Within a GMP quality management system, equipment and process controls focus on the following areas: Dedicated production lines, combined with appropriate equipment and process controls, provide the foundation for Fivevet to maintain manufacturing conditions that meet WHO-GMP requirements.
For international importers and distributors, these are important factors when assessing a manufacturer’s ability to control quality and maintain product consistency throughout a long-term partnership.
3. Weighing, Dispensing, and In-Process Control
Once approved for use, raw materials are weighed and dispensed according to the approved formulation and manufacturing instructions.
Weighing and dispensing must ensure:
- The correct raw material.
- The correct batch number.
- The correct weight.
- The correct formulation.
- The correct material status.
- The correct identification of areas and equipment.
During manufacturing, process parameters and inspection results need to be recorded in the batch records.
With its WHO-GMP production lines, Fivevet can manufacture a range of veterinary dosage forms, including powders, oral medicines, injectables, tablets, granules, ointments, eye drops, and vaccine products.
Each dosage form has its own technical characteristics and requires appropriate controls during manufacturing:
Powdered Medicines
Control mixing, mixing time, and blend uniformity according to the requirements of each product.
Liquid Medicines
Monitor parameters including pH, uniformity, fill volume, or other physical and chemical properties.
Tablets
Control tablet weight and other technical properties related to the dosage form.
Sterile Products
Control manufacturing conditions according to the technical requirements and risk level of each product.
Throughout manufacturing, batch identification, control of technical parameters, area cleaning, and production recordkeeping are important parts of the quality management system.
The ability to manufacture a range of dosage forms gives Fivevet a foundation for developing and supplying veterinary pharmaceuticals that serve different market needs. This is also an advantage for international importers and distributors seeking a partner with a broad product portfolio and the capacity for long-term cooperation.
4. Packaging and Product Packaging Control at Fivevet
Packaging is an important step in veterinary pharmaceutical manufacturing, helping protect product quality during storage, transportation, and distribution.
At Fivevet, packaging operations include controls for packaging materials, product labels, batch numbers, expiration dates, and packaging specifications according to each product’s requirements.
Packaging control focuses on three main stages:
- Before packaging: Check the condition of the line, equipment, packaging materials, and relevant documents; perform line clearance to reduce the risk of mix-ups between products or production batches.
- During packaging: Check product identification, batch numbers, expiration dates, information printed on labels, quantities, and packaging condition.
- After packaging: Reconcile product quantities and the packaging materials and labels used; inspect the packaging condition and complete the relevant records.
Packaging and Label Customization for Export Markets
Alongside quality control, Fivevet works with international importers and distributors to review packaging options suited to each market.
Depending on the product’s characteristics, legal requirements, order quantity, and manufacturing conditions, discussions may cover:
- Label language: Reviewing changes to the language used for product information to meet the importing market’s requirements.
- Packaging specifications: Selecting options suited to the product, distribution needs, and production line capabilities.
- Packaging information: Working together to review the product name, ingredients, directions for use, warnings, and other information required by regulations in the destination market.
Customization options must align with the product registration dossier, the importing country’s legal requirements, and Fivevet’s actual production capabilities.
Working together on labels and packaging helps partners better plan product registration submissions, build their product portfolios, and launch distribution activities in their target markets.
After manufacturing and packaging, how is each product batch tested, reviewed for release approval, and stored at Fivevet? Find out in Inside Fivevet’s Veterinary Drug Manufacturing Facility: From Raw Materials to Finished Products (Part II). (chèn link phần 2 khi có bài)
Frequently Asked Questions
1. What Veterinary Dosage Forms Can Fivevet Manufacture?
Fivevet can manufacture a range of dosage forms, including powders, oral medicines, injectables, tablets, granules, ointments, eye drops, and vaccine products. Each dosage form is subject to appropriate technical requirements and controls during manufacturing.
2. How Does Fivevet Control Incoming Raw Materials?
Raw materials undergo checks covering material information, quality documents, batch numbers, suppliers, and packaging condition. They are also sampled, tested, and assessed according to applicable procedures and specifications. Only materials that meet quality requirements and receive approval are used in manufacturing.
3. Does a Supplier’s CoA Replace Raw Material Testing?
No. A Certificate of Analysis (CoA) is a document used to assess raw material quality. At Fivevet, the CoA is reviewed alongside test results and other relevant quality information. It does not replace all necessary control and testing activities.
4. How Does Fivevet Maintain Consistency Across Product Batches?
Controls include raw material quality management, equipment and system qualification, process validation, cleaning validation, and change control. During manufacturing, raw materials are weighed and dispensed according to the approved formulation, and process parameters and inspection results are recorded in the batch records.
5. Can Fivevet Help Adapt Labels and Packaging Specifications for Export Markets?
Fivevet works with international partners to review label language, packaging information, and packaging specifications suited to the importing market. Implementation depends on the product’s characteristics, registration dossier, legal requirements, order quantity, and actual manufacturing conditions.
Read our detailed guide on: Fivevet, Large-Scale Veterinary Pharmaceutical Manufacturing in Vietnam