Setting a whole manufacturing unit in the pharmaceutical sector is not a piece of cake. You have to keep in mind a lot of things like the rules, requirements, and so on. By the end of this blog, you will be able to understand the requirements. So, let’s get started without any further delay.
The first thing which you should know is, what is manufacturing in this sector?
Pharmaceutical manufacturing refers to the process of purchasing raw materials, processing, producing, packaging, releasing, storing, and shipping medicines and pharmaceutical products in accordance with good manufacturing practices.
Finding out the perfect and most suitable place for the manufacturing unit is crucial, and you might have to keep a couple of things in mind. Ensure that the building or place you are about to finalise complies with the GMP (goods manufacturing practice) standards.
Here are a couple of things which you need to check in the place and area.
Receipt and storage of raw materials
Areas of the manufacturing process
Section of quality control
Store for finished goods
Office
Merchandise/drugs store for rejected goods
Different sections had distinct space and prerequisite requirements. The minimum area needed for each section set up in a pharmaceutical manufacturing unit will be discussed here.
External preparation section - A minimum of 30 square meters is required for the basic installation, with an additional 10 square meters needed for the ancillary area.
Liquid dosage form section - It requires the same area as the external preparation section. A minimum of 30 square meters is required for the basic installation, with an additional 10 square meters needed for the ancillary area.
Solid dosage form section - This section requires more area than the above-mentioned ones. A minimum of sixty square meters is required for the tablet section for basic installation, and twenty square meters is required for ancillary. The powder section requires at least thirty square meter area for basic installation and the square meter area for ancillary. For the Capsule section, the basic area for installation should be more than a twenty-five square meter area, and the ancillary area is the same as the powder section.
Ophthalmic preparation section - This section is an extremely sensitive area. So it is advised to plan it in some other building.
Parenteral Section - It is also one of the sections that require utmost safety. So, it is advised to plan this section in some other building. There is one more thing, and that is to make sure to separate the dry powder and liquid sections. A minimum of 150 square meters is required for basic installation, and 100 square meters is required for ancillary activities in a parenteral section.
Now is the right time to have a glimpse of the requirements that you need to fulfil.
GMP-compliant remises, building, and plant
Section-by-section partitioning in the plant
Technical Personnel (Manufacturing chemist and Analytical Chemist)
Laboratory and machinery equipment
Supervisors and workers in HVAC units
List of medicines to be manufactured NOC from required departments, such as the pollution board and the MC, if applicable.
Licenses for manufacturing and distribution
Factory Registration under the Factory Act
Suppliers of Raw Materials
Suppliers of Packaging Materials
For output consumption, distributors and/or marketing companies are needed.
Licenses that are required:-
You will have to apply for multiple licenses, and that too depends upon your location and area. Here are some of the licenses that you must have to start with a manufacturing unit.
Registration of a Business (If required)
Licensing for Drug Manufacturing and Licensing for Drug Distribution (For Distributing finished goods)
Good and Service Tax (GST) or any other tax registration required in the concerned country NOC from other departments if necessary
You have seen all the requirements for starting a manufacturing unit. If you are wondering whether it is easy or not, then the answer is quite evident. You need a lot of things and time to set up a manufacturing unit.
It is best to invest in a PCD Pharma business rather than manufacturing one. The best way to analyse the market and choose the best franchise is to search for the top 10 PCD pharma companies in Maharashtra.
You can also contact us if you are struggling to find the best PCD Pharma Company in Maharashtra. After analysing everything, choose the most suitable option for you.