Industrial Visit
The industrial visit was organized by LJ Institute of Pharmacy to the company named Corona Remedies PVT. LTD., Bhayla in two slots. First slot was taken on 04/03/2023 which comprised of 54 students and 3 faculties accompanying them and Second slot was taken on 11/03/2023 which comprised of 47 students and 2 faculties accompanying them. B.Pharm Sem VI students were taken.
The company was established in 2004 and mainly deals with research, manufacturing, and marketing of pharmaceutical products. The plant is WHO-GMP certified. They follow the EU regulatory guidelines. They have strong presence in therapeutic areas such as Anti diabetic, anti hypertensive, neuropathy, hormones, women healthcare and nutritional supplements. The plant is expanded in an area of 28000 m2 comprising of OSD unit and further expansion of Female hormone unit is in process.
Objectives of the visit-
· For students to explore industrial environment
· To build up practical knowledge and implementation
· To understand the protocols of the pharmaceutical industry
· To correlate the theory knowledge with the practical
The areas students visited and the flow of events-
· Raw material and warehouse
Raw materials were kept in this location for storage. IPA is used to disinfect all raw materials before they are brought into this chamber. The vendor and purchase order must be verified before entering the storage area, and only after approval can raw materials enter the building. After entering the area weight and quantity verification is performed. The sampling tests of API and excipients are performed.
· Reverse laminar air flow
The materials enter the different rooms through dynamic passbox comprising of HEPA filters to avoid contamination. The raw materials are opened in this area.
· Production area
The production area was the first portion of the building we entered, and it led to the gowning room, which had separate areas for men and women and the purpose of gowning is to prevent bacterial contamination.
· Storage area
It has the temperature and RH within acceptable ranges. It had three racks for various tags. Yellow marks indicate items that are undergoing testing, whereas green tags designate materials that have received approval. There are distinct dispensing booths available for various weights. Verifying balances is an important component of business. IPA and DMC have different drums available for solvents.
· Milling and sifting area
The materials after the removal of moisture and purification go to the quarantine area. Granulation is done after this process; FBP is used to remove moisture. After this blending of the excipients and API is done and the blend is sent to QC for approval.
· Compression
After the approval from QC the blend is converted to tablets, capsule or sachets according to the formulation by compression. The deduster removes the dust from tablet surface. All the parameters of the tablet are verified by automated machines and manually also.
· Washing area
All equipments are made up of SS 316/304 to prevent microbial contamination and washed here.
· Coating area
In this area the compressed and approved tablets are coated by the spray
Coating mechanism and verified by auto check wares.
· Packaging
The primary blister packaging and secondary packaging is done by automatic
Machines and quantity verification are done by the scanners. The packaging is
done in specified temperature and RH.
· QC lab
Consists of different equipments like HPLC, dissolution and disintegration for
verifying different parameters. The ADL (Analytical development laboratory) is a
Specialised lab for research and development of new molecules.
The F and D lab (Formulation and Development) checks al the parameters of the API and excipients brfore the formulation is designed.
· Documentation
The documentation of every aspect is recorded and followed according to the guidelines and has to be stored for at least 4 years before destruction or disposing the records.