Injectable Manufacturer in India – India is a huge market for pharma companies and is booming year after year. Many foreign companies also have their eyes glued to find an opportunity to do business here. You may have also come across many companies like Scotmed Care, and others. These companies are manufacturing injectables in India. But what distinguishes the best from the rest is something to ponder upon.
In layman’s terms, any manufacturing unit for injectables is based on four pillars. These are:
- Material selection and quality of the materials used
- Process automation to sustain the supply
- Quality through testing and inspection, and
- Customer service
Any company following these is bound to build and sustain in the Indian market. But there is another aspect that needs attention and that is a certification for the injectable manufacturer in India.
No matter you want to establish a firm or scrutinize any existing firm, certification is a must. Otherwise, the government can shut you down and it will affect the brand value of the company. So, what are these certifications and their significance?
Certifications required by any injectable manufacturer in India
Before we foray into the certifications required for the companies, let us first understand the significance of the certificates. A certificate, in plain terms, is an official document attesting to a fact. The authorities can provide the certificates if companies meet the required demands. For instance, ISO is an international organization for standards and they provide some guidelines to the companies. When you abide by the guidelines, ISO provides a certificate of authenticity.
Similarly to this, other organizations provide certificates to pharma companies. These certificates pose proof of standardization and quality. It may be related to a product, process, or even the organization. Now that you understand the value of the certificates, we will discuss the basic certificate requirement for any injectable manufacturer in India.
ISO 9001 is the most common certificate that you will find associated with any manufacturing unit. A manufacturing unit must be complying with the standards mentioned in the ISO document of standards. Another certificate required is the GMP certificate which stands for Goods manufacturing practices. This is a quality management system related only to the materials and finished goods.
ISO 9001 vs GMP
The most recent development in the quality standards in manufacturing is ISO 9001:2015. ISO 9001 can be used by any manufacturer from any field. However, you have to follow all the guidelines properly to pass the standardization test. ISO 9001 documents all processes to ensure quality policies and objectives. It not only includes products but also includes the people involved in the production of goods and services. In a capsule, there are seven management principles:
- Customer-centric focus
- People engagement and shared responsibilities
- Continuous improvement in goods and processes
- Factual Decision-making process
- Process approach
- Relationship management
On the other hand, GMP is only related to the goods. It ensures that the goods produced are conforming to the quality standards defined for a particular good. It is mostly involved with pharmaceutical production to minimize the risk of health damage through poor quality or contamination of goods. GMP guidelines are set World Health Organization. You can contact Scotmed Care for the critical care Injectable franchise, which is a GMP Certified Company in India.
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