When we talk about pharma manufacturing company, we refer to operations that include purchasing raw materials, processing, production (including packaging), release, storage, and shipping medicines and pharmaceutical products according to Good Manufacturing Practices (GMP) regulations.
What should we do first?
Before starting a medicine manufacturing company unit, one should understand the pharmaceutical industry, including manufacturing, marketing, administration, etc. Alternatively, one should hire or form a partnership with individuals who have extensive experience in manufacturing and analytical procedures. Even after spending a large sum of money, it is impossible to compete or thrive in the pharmaceutical sector if one does not understand the industry.
The search for a location to house a manufacturing facility is also an essential phase in the manufacturing unit setup process. The site and construction of the facility should follow Good Manufacturing Practice (GMP) requirements. GMP standards and plant specs may differ somewhat or significantly depending on the country’s regulations and needs.
The following is the area required by a pharmaceutical manufacturing company:
The medicine manufacturing company facility should have enough room for the following items:-
- Taking delivery of and storing raw materials
- Areas of the manufacturing process
- Section of quality assurance and control
- Finished-goods warehouse
The store that turned down goods or medications
- A variety of space and requirement specifications were necessary for various areas. This part will cover the minimum space required for each section setup in a pharmaceutical production facility.
- A minimum of 32 square meters is necessary for the basic installation of the External Preparation section, with an additional 11 square meters required for extra space. To minimize cross-contamination, exterior and interior preparations’ formulation should be separate.
- Tablets, capsules, and powder are solid dosage forms that demand more space for installation and supporting equipment.
- For uncoated tablets, a minimum of sixty square meters of floor space for the basic installation and twenty square meters of floor space are necessary. If a coating section is needed, it should be located separately from the other areas and have a minimum distance of thirty square meters for the basic installation and ten square meters for auxiliary equipment and supplies.
- The basic installation of a capsule section needs a minimum of twenty-five square meters of space, with an additional ten square meters required for auxiliary.
- Like the parenteral section, the Ophthalmic Preparation Part is a susceptible section. Should locate parts in a separate structure or at a different location from the other units described above.
- A completely airtight, sterile, and non-contaminated environment is essential for ophthalmic preparations. The ophthalmology sector requires a minimum of twenty-five square meters of space, with an additional ten square meters necessary for extra space.
There are two sorts of the parenteral section, such as ampoules and vials for injections, among other things. The first category is pharma manufacturing company preparations such as dry powder for injection, while the second category is liquid injections.
It should be in a separate facility, and dry powder should be kept separate from the liquid. The amount of space required varies depending on whether the parenterals are for significant volumes or tiny fluid volumes.