INDUSTRIAL MANAGEMENT ASSIGNMENT (IN-PLANT TRAINING WRITE-UP)

SHRUTI PANDEY FINAL YEAR BTECH PHARMA 200903052012

IPT LOCATION-

DR. REDDYS LABORATORIES (VISAKHAPATTNAM) INTRODUCTIONProfessor P.R.Vavia sir put in a lot of persistence to get me an eight weeks internship in Dr. Reddys Laboratories, Visakhapattnam, A.P. Dr. Reddys Laboratories is an integrated pharmaceutical company founded by Dr. Anji Reddy who is also an alumni of ICT, Mumbai. ABOUT THE PLANTDr. Reddys has its seventh Formulation and Technical Operations (FTO-7) facility at Visakhapattnam. This plant located in VSEZ (Vizag South Economical Zone) of Visakhapattnam, Andhra Pradesh was inaugurated on 26th September 2006. FTO-7 unit of Dr. Reddys is facilitated to produce cytotoxic and anti-hormonal drugs for curing cancer, mainly for export to the development markets of the US and the EU. It has the capacity of producing 40 million cytotoxic capsules, 40 million anti-hormonal formulations and seven million injectable per annum. It had been set up at a cost of Rs 40 crore. This unit is benchmarked to the highest global regulatory standards and it produces drugs conforming to the most stringent standards. The unit is equipped with modern infrastructure and isolation technology used to handle potent compounds. AROUND THE PLANTThe core functioning of the plant in relation to the product is as follows-

Warehouse department

Production department

Quality control department

QA and storage

Dispensing of the product

Water purification and The warehouse, production and quality control departments are closely knit departments and work simultaneously with each other for the manufacturing of the products. These departments are inter-connected with the double door pass boxes. The water purification takes place in a separate unit as per the USFDA norms and requirements and reaches the production department through a sophisticated pipe line system. The quality assurance department has its bases within the production department and a separate office for all

documentations. Other auxiliary departments included the Technology Transfer Group (TTG), Engineering, HR, IT and a profound security system. The production department had 2 blocks Block A and Block B. Block A deals with the production of oncology related products which include both solid dosage products and parenterals. Block B deals with conjugated oestrogens and related products. However this facility is new flanged and is yet under constructions. MY PROJECTFTO-7 was a state of art facility with stringent norms due to the potency of all the products manufactured in the plant. It was a fascinating experience to see the pharmaceutical industry function without missing on the slightest of details as here they hold the fate of innumerable patients. The company policy ruled that women employees cannot enter the production area. As an intern, I was made an exception to this rule and allowed to understand the functioning of the products manufactured. However, I could only watch the production process from the visual inspection room and was not allowed to have a hands-on or a close look at it due to the microbial contamination limits. It required special Tyvak suits and air masks to get into the manufacturing unit. At once only 10 experts could be inside. The entire process was completely mechanical with sophistication machinery doing it all from cleaning of the vials to the sealing. Man power is only required for a limited processes. The process of manufacturing was batch process. The machinery studied in the production department at large was Lyophilizer, Autoclave, VHP machine, SIP machine and Glove integrity tester. The vials produced are carried ahead for visual inspection which was one of the activities I indulged in. here is a close up picture preview of the facility-

The next visit was to the Quality Control department. Here I was allowed to have a hands-on experience on the HPLC system after a weeks training on this intricate machine not without supervision. The procedures were laid down. The results were printed and submitted to the analysts for the records. Apart from operating HPLC, I had the chance to see all the tests for the quality check of the products as well as for the primary, secondary and tertiary packaging materials. Further to these two departments, I visited the engineering department which took care of the part of the validation of the machines in sync with the TTG department, the generators, the AHUs and related engineering aspects. The quality assurance department maintained serious records and all the vigilance as to all the production activities are following the rules put forth. The line clearance for all production activities was given by Quality Assurance department. The TTG department helped me understand the Validation Master Plan and also how overview of companies strategies in terms of product business.

SUGGESTIONSDuring my tenure in the production department I studied the USFDA requirements for a pharmaceutical company manufacturing oncology product. This plant had the minutes details essential except one little. I bought this to limelight that at the entrance of the production department there needs to be a sensitive compressed air duster. This would help dust the possibly contaminated air around the person whilst entering the production department. My detail was appreciated and the air duster was incorporated before my tenure in the company was completed. HIERARCHYAs I got to have an overview of the company, I got a chance to interact with the heads of all the departments. The daily chores of the company started with all the head of departments and dignitaries having a meeting about the days activities and future paces. Each department had a board with the set target for the month and also the employees had team leaders to guide them. Every month a department was awarded as the best department. The best employee awards were also given through the departments. All this kept the employees motivated. The team spirit was always maintained throughout the company. CONCLUSIONAs I student I couldnt have asked for more than the experience I was exposed to. My learning curve moved swiftly. It gave me path to apply all the theoretical knowledge gained in ICT. As a part of the curriculum, IPT report was submitted and a seminar was held in college.