Pharmaceutical Contract Manufacturing: Ensuring Quality and Compliance
The pharmaceutical sector relies on safe, reliable and quality products. Pharmaceutical contract manufacturing is integral to fulfilling these criteria while allowing process development and costs to be kept low. This blog details the concept of pharmaceutical contract manufacturing and how it can provide quality and compliance consistency in future operations.
Inside Pharmaceutical Contract Manufacturing
Pharmaceutical contract manufacturing entails partnering with manufacturers that specialize in medication production. These manufacturers manage various components of medication production including formulation, blending, filling, packaging and labeling. Many pharmaceutical brands partner with them to reduce infrastructure investments, manage supply chains and scale more rapidly.
This process allows companies to focus on the research, development and marketing of their products while still ensuring that their products meet high quality standards. Contract manufacturers are subject to regulated compliance systems that include certifications that ensure that every product that leaves their facility is safe and effective.
Why Pharmaceutical Contract Manufacturing Matters
By using an external contractor for production, pharmaceutical companies will have the flexibility to operate and broaden their portfolio of products without re-investing their fixed capital. They will also use modern technology and personnel experience to work more efficiently. There are several benefits to outsourcing production:
- Cost Effective: No need to invest new production facilities (or equipment to produce products).
- Expertise: Professional and advanced infrastructure.
- Scalable: Manufacturing can be ramped up or down in accordance with demand.
- Focus: Parent company will focus on its core business, R&D and selling/marketing.
- Regulatory Compliance: The contract manufacturer is required to comply with national and international quality standards.
Ensuring Quality and Compliance in Contract Manufacturing
Quality and compliance are the foundation of pharmaceutical contract manufacturing. A controlled process is followed at every step of the manufacturing process, from sourcing of raw materials to the final packaging and this process complies with strict regulatory requirements.
1) Quality Management Systems
A robust QMS ensures consistency, documentation and traceability. Each step of the manufacturing process is validated and monitored to maintain product safety and efficacy. Manufacturers also conduct the internal audits, as well as corrective actions, to maintain the continual improvement.
2) Regulatory Compliance
Contract manufacturers must meet the requirements of the various global and regional regulatory authorities. These requirements includes
| Certification | Standard Ensured | Purpose |
| GMP | Product quality and the safety | Assurance of consistent manufacturing process. |
| WHO GMP | International compliance | Aligning production with the globally recognized standards. |
| ISO 9001 | Quality management | Focus on customer satisfaction and continual improvement. |
| DCGI Approval | National regulatory compliance | Enables the legal manufacture and the sale of medical devices in India. |
3) Raw Material and Supplier Verification
We verify suppliers through audits and reviewing documents and records. Only approved suppliers are used for sourcing active pharmaceutical ingredients and excipients.
4) In Process Quality Checks
Each batch goes through numerous quality checks both during and after production. Some of the more frequent checks, as examples, include the following:
1. Stability testing
2. Microbial testing
3. Dissolution testing
4. Visual inspection
All data is recorded and evaluated for accuracy and consistency
Final Thoughts
Pharmaceutical Contract Manufacturing focuses on the quality and the compliance through rigorous systems, certified processes and innovation. Nualter Herbovet is a company you can count on for pharmaceutical and veterinary manufacturing that maintains these principles through ISO, GMP and WHO GMP certified facilities. They boast expertise in allopathic formulations, veterinary formulations, herbal formulations and ayurvedic formulations. Nualter Herbovet provides safe and effective medicine for humans and for pets and livestock.
FAQs
Q1. What are the stages of pharmaceutical contract manufacturing?
Stages include formulation, blending, filling, packaging, labeling and quality testing.
Q2. What is a Quality Management System?
A Quality Management System provides consistency, traceability and continuous improvement during production.
Q3. Why do pharmaceutical organizations employ contract manufacturers?
To lower production costs, increase efficiencies and allow companies to concentrate on research, development and marketing.