What if the medicine doesn’t have the desired effect? The sales of that medicine will decrease, or worse, the drug will be rejected completely. That’s why the API manufacturing in India is becoming more prominent to improve the quality of the drug. The quality and compliance measures are necessary to measure the quality of the API and market it in the international market.
Here are a few more reasons why API compliance in India is important:
- Develop safe and high-quality drugs
- Reduce the contamination risk
- Maintain quality consistency in all batches
- Alignment with global regulatory expectations
- Pass the drug regulatory compliance in any market
The Indian API industry prioritizes regulatory compliance to reduce the reliance on other countries. The regulatory compliance backed by PLI and other schemes is showing positive results. As per a source, 191 APIs/KSMs/DIs have been manufactured/produced for the first time in India under these government schemes. It shows the growth potential of the API market in India.
In this blog, we will discuss how Chemox Pharma meets quality and compliance standards for API manufacturing in India.
How Chemox Pharma Ensures Quality Compliance for API Manufacturing in India
Chemox Pharma is known for WHO GMP api manufacturing in India. We have been developing the critical APIs and Intermediates to strengthen India’s pharma industry. The following are a few measures we take for quality and regulatory compliance to provide our products to pharma companies in India and beyond.
State-of-the-art infrastructure
The infrastructure of any pharma company is of great importance. Therefore, we set up our R&D and manufacturing facility in Dahej. Our manufacturing unit has state-of-the-art infrastructure with the best equipment and result-driven procedures. We ensure that the facility is clean and has a controlled environment for the safety and efficacy of the API.
We invest in high-quality equipment and set up quality control mechanisms for multi-step chemical synthesis and handle the sensitive pharma products efficiently.
GMP certification
Good Manufacturing Practices (GMP) standards are one of the most crucial ones in the Indian API industry. Having a good GMP certificate is essential to show that your manufacturing facility adheres to safe production standards and that all your products have consistent quality.
The GMP guidelines are provided by different regulatory authorities in the pharma industry. The following are things included in GMP standards:
- Cleanroom protocols
- Equipment validation
- Personnel training (especially the ones involved in API manufacturing)
- Documentation accuracy
- Controlled manufacturing processes
Chemox Pharma follows the WHO-GMP standards. We maintain our facility, train our team, and manage the documents for safe and transparent development. Our WHO-GMP certified API manufacturing company in India exports critical APIs to 20+ countries. Contact us to know more.
Regular DMF submission
Drug Master Files, or DMFs, are critical for pharma companies in the API market in India. The DMF file discloses the API manufacturer’s facilities, processes, and materials used in the manufacturing, quality control processes, packaging, and storage techniques of APIs.
These files are essential to create a reliable image in the API market in India and other countries. Chemox Pharma regularly files the DMFs to meet the compliance needs and maintain transparency in the manufacturing process.
Advanced Quality Risk Management (QRM)
The APIs are responsible for the therapeutic effect of the medicines. Therefore, its efficacy needs special attention. Chemox Pharma has implemented an advanced quality risk management system on all the critical control points. It allows us to identify any inconsistency or impurity in the API manufacturing process. Thus, all our APIs are of consistent quality and safe for developing critical drugs.
Environmental and Safety Regulations
We are a socially responsible pharma manufacturing company in India. Therefore, not only do we do ESR initiatives, but we also ensure that our manufacturing unit isn’t harming the environment.
For this, we focus on:
- Managing waste treatment systems for safe disposal
- Using zero-liquid-discharge (ZLD) processes
- Conducting regular safety audits
- Using proper PPE and training
- Managing hazardous materials responsibly
Skilled development team
A skilled team is essential to maintain the quality and safety of the APIs. Chemox Pharma works with a highly qualified team for each department, especially in R&D and the manufacturing unit. We also provide advanced training focused on controlling the impurity profile, following the safety measures, and learning the high-yield process. It helps us build a competitive edge and become a compliant API supplier in both domestic and international markets.
In-House analytics system
Chemox Pharma invests in rigorous analysis at all critical points of API manufacturing. Before the drugs are used, Quality examination guarantees that the API is in its purest and most stable form, thus making it both effective and safe.
Our laboratories utilize the most advanced devices and techniques, including spectrophotometers, microbial and endotoxin testing, stability testing and more. This not only ensures our adherence to regulations but also plays a part in the production of safe APIs.
Regulatory Audits and Inspections
Chemox Pharma always maintains its facilities and follows the regulatory standards. Therefore, we are always ready for any regulatory audits conducted by the regulatory authorities, third-party, and more. It helps you cement our resolve to create safe and high-quality APIs under budget to make drugs more affordable.
Post-Market Surveillance
Our commitment to quality compliance isn’t limited to production, but also after production. We take post-market surveillance from customer feedback, product performance, long-term stability patterns, and analyze any complaints to identify any improvement areas. These steps help us ensure that our products are safe and that the quality of the drug is maintained.
You can check our 19 commercially available APIs and get them customized based on the INH, BP, USP, IP, and EP pharmacopoeia standards. Contact us to know more.
Conclusion
Quality compliance is essential for any pharma company, especially for API manufacturing in India. Therefore, Chemox Pharma pays close attention to quality control and regulatory compliance of our procedures, personnel, and facility. We are a WHO-GMP-certified pharma company. We adhere to strict regulatory guidelines with the state-of-the-art infrastructure, DMFs, quality assurance, team training, analytics, and post-market survey. Contact Chemox Pharma to customize the quality of APIs based on your needs.
FAQ
What is compliance in the Indian API Industry?
Compliance in the pharma industry refers to the guidelines set by regulatory authorities such as CDSCO, ICH, WHO, and other international agencies for creating safe and high-quality pharma products. These guidelines are related to the manufacturing process, data integrity, risk management, impurity profiling, personnel training, and more. It ensures that the pharma manufacturers are operating safely.
Why does API compliance in India matter?
The API compliance in India ensures that it meets the global standards. When your drug complies with these standards, you can easily enter global markets, get better clients and gain customer trust. Non-compliance indicates that pharma products aren’t safe and have lower drug efficacy.
Where to find GMP-certified API manufacturers in India?
You can find trustworthy API manufacturers with GMP certification in India through pharma directories, pharmaceutical exhibitions, websites of regulatory authorities, and pharmaceutical associations. Chemox Pharma is one of the companies in India that has WHO-GMP certificates for API production. We produce highly safe and effective APIs at low costs so that medicines become more affordable.
How to Verify GMP Certification Authenticity for an API manufacturer?
It is advisable for buyers to not only ask for a copy of the GMP certificate but also to carry out a thorough inspection of the issuing body and then to verify its authenticity by visiting the official website of the auditor. The other steps might involve inspecting audit reports, performing supplier audits, scrutinizing documentation practices, and checking compliance records.
