Introduction to Pharmaceutical Factory

Introduction to Pharmaceutical Factory

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The manufacturing base of Pharscin Pharma was foundedin November 1996 and is located in the National High-tech Zone, RongchangDistrict, Chongqing. The pharmaceutical factory hasa phase I, phaseII and phaseIII engineering production lines with a total areaof more than 170 mu, and a GMP production base covering an area of more than160 mu and will meet therequirements of EMA and FDA. The green area accounts for 42.5% of the totalarea. The garden-type factory area is clean and beautiful.PharscinPharma has built 11 production lines, including tablets, powders, granules,hard and soft capsules, powder injections, freeze-dried powder injections,small volume injections, raw material syntheses and plant medicine extractions.Among them, the soft capsule production line filled in the blank of chongqingat that time, and the API of Weidimei(Hydrotalcite Tablets) has been registeredby DMF of FDA in the United States.Theproduction equipment and technical performance of Pharscin Pharma meet theinternational standards, achieving the professional production control,automatic detection, pipeline delivery and mechanic packaging.The fifth phase of the new GMP production base will beconstructed in strict accordance with the cGMP standard of ICH so as tocomprehensively realize intelligent manufacturing. The company intends to passEMA and FDA cGMP certification on this platform to make it possible to get drugapprovals by CFDA, EMA and FDA at the same time and enable the simultaneousaccess to the markets of China, the United States and Europe in the future.



PharscinPharma has advanced manufacturing technology and excellent facilities . The extensive application of advancedtechnology provides a higher standard of quality assurance of the products for Pharscin Pharma. Pharscin Pharma has applied advanced modernpharmaceutical technologies such as CO2 supercritical extraction, ultrasonicoscillation extraction and new processes of macroporous resin adsorption purification,ultra-low temperature pulverization, vacuum belt drying and vacuum freezedrying to manufacture premium products. For instance,Weidimei (Hydrotalcite Tablets),Duliang Soft Capsuless, Danshu Soft Capsules, Tongxie Ning Granules, GanjuBinmei Tablets, Odeman (Terazosin Hydrochloride Capsules), Shuiwang (Spirulina Ccapsules),Oxymatrinefor injection, Diammonium glycyrrhizinate for injection, Sodium Ferulate forInjection, Mebexyl for Injection, Sodium Omeprazole for Injection, SodiumAescinate for injection, Pefloxacin Mesylate for Injection, InjectionAcyclovir, Citicoline for injection, Ethylenediamine Diacetamide Acetate forInjection, Bumetanide for Injection, Calcium Folinate for Injection, andNetilmicin Sulfate for Injection.


Sinceits establishment, Pharscin Pharma takes drug quality as the life of theenterprise. The drug production of company is strictly in accordance with thecurrent applicable GMP standards (2010 version) and 6S management. Withconstant improvement in quality management, the company has ensured thequality, efficiency and safety of drugs. In 2004,the pharmaceutical factory was awarded "Advanced Unit of QualityManagement of Chongqing Small and Medium-sized Enterprises". Since theestablishment, the company's manufactured products in the finished productsinspection, sampling inspection of the Food and Drug Administration, nationalevaluation sampling inspection and market sampling inspection have always been100% qualified. Pharscin Pharma drugs have been unanimously praised by themajority of medical staff and patients.


While Pharscin Pharma places high on its agenda,it also pays closerattention to the production management and organizes production strictly inaccordance with the process specification. In addition, it also strictlyfollows the standard operating procedures, equipment standard operatingprocedures, post cleaning standard operating procedures and other GMP documentsto make accurate notes in a timely manner to guarantee production operationsand effectively eliminate errors. In 2008, QC team of theproduction technology department won the "National Excellent QualityManagement Team", and in 2016, it was nominated for the Chongqing MayorQuality Award.

Tablet, Capsule and Granule production lines

Tablet, Capsule and Granule production lines

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Pharscin Pharma tablet, capsule and granuleproduction lines first passed the GMP certification of the state food and drugadministration in 2001, and then passed the GMP review certification with theexpiration of 5 years in 2006. It also passed the 2010 GMP certification withthe expiration of 5 years in 2011 and 2017 respectively.Thethree production lines are designed and built in strict compliance with thetechnological process of oral solid preparation and Class D clean zonerequirements. Thanks to its advanced equipment and high degree of automation,"four advanced production technologies" , which refer to productionprocess control, delivery by pipeline, automatic detection and mechanicpackaging, have been truly realized. As a result, the quality of products iseffectively ensured. Among equipment in this factory, ultra-low temperaturecrusher, high-efficiency wet granulator, high-efficiency boiling granulator,vacuum rotary dryer, automatic dust-free tablet press, automatic particlepackaging machine, automatic aluminum plastic packaging machine, automaticdouble aluminum packaging machine and fully automatic bottling production lineare all international and domestic leading equipment.The application of ultrafine low-temperaturepulverization technology has improved the dissolution effect andbioavailability,taking product quality to a new high.Theannual production capacity of the tablet production line is 2 billion, theannual production capacity of the capsule production line is 1 billion, and theannual production capacity of the granule production line is 50 million bags.All kinds of verification and daily monitoring inthe production workshop are strictly implemented in accordance with theprovisions, effectively ensuring the stability, uniformity and control of theproducts produced by the production line.

Soft capsule and powder production line

Soft capsule and powder production line

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Pharscin Pharma capsule and powder production linesfirst passed the GMP certification of China Food and Drug Administration in2004, and the soft capsule production line filled in the blank of the softcapsule production line in Chongqing at that time. Thesetwo production lines passed the 5-year GMP review and certification in 2009,and passed the 2010 GMP certification in 2014.Thetwo production lines are designed and built in strict compliance with thetechnological process of oral solid preparation and Class D clean zonerequirements. Thanks to its advanced equipment and high degree of automation,"four advanced production technologies" , which refer to productionprocess control, delivery by pipeline, automatic detection and mechanic packaging,have been truly realized. As a result, the quality of products is effectivelyensured. Among equipment in this factory, fully automatic pill-pressingmachine, automatic aluminum-plastic packaging machine, fully automatic bottlingproduction line, cryogenic crushing equipment and fully automatic lowtemperature granular packaging machine are cutting edge at home and abroad.The annual production capacity of soft capsulesproduction line is 1 billion, while the annual production capacity of powderproduction line is 60 million.Theverification and daily monitoring of the workshop are carried out by strictlycomplying with relevant provisions in order to effectively ensure the productsproduced through production line are stable, homogeneous and controllable.

Production lines of powder-injections, freeze-drie

Production lines of powder-injections, freeze-drie

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Theproduction lines of powder-injections, freeze-dried powder injections andsmall-volume injection of Pharscin Pharma were at first certified to GMP by theChina Food and Drug Administration in 2004. The said production lines weresuccessfully certified to GMP again in 2009 when its first certification wasexpired 5 years later and the GMP of 2010 Version in 2013. These threeproduction lines are designed by strictly complying with the technologicalprocess of sterile preparation and Class A, B, C, D clean zone requirements.All exposed location of supplies, rubber plug, bottles and containers, etc. areprotected with the Class A laminar flow hoods, which have effectively preventedpollution and cross contamination. Thanks to its advanced equipment and highdegree of automation, "four advanced production technologies" , whichrefer to production process control, delivery by pipeline, automatic detectionand mechanic packaging, have been truly realized. As a result, the quality ofproducts is effectively ensured. Among equipment in this company, proportioningsystem, fully automatic ultrasonic bottle washer, fully automatic rubber plugcleaner, fully automatic aseptic sorting machine, fully automatic asepticfilling machine, vacuum freeze dryer, fully automatic drawing filler, fullyautomatic water bath sterilization and leak detection equipment, etc. arecutting edge at home and abroad. The annualproduction capacity of powder-injections production line is 100 million. Theannual production capacity of freeze-dried powder injections is 10 million. Theannual production capacity of small-volume injection is 500 million.The verification and daily monitoring of all productionlines are carried out by strictly complying with relevant provisions in orderto effectively ensure the products produced through production line are stable,homogeneous and controllable.

Production line of extracting traditional Chinese

Production line of extracting traditional Chinese

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Production line of extracting traditional Chinesemedicine in Pharscin Pharma was carried out by the "Chongqing MunicipalModern Engineering and Research Center for Traditional Chinese Medicine"of "National Modern Engineering Technology Center for Traditional ChineseMedicine" . It was first certified to GMP by the China Food and DrugAdministration in 2001, and was successfully certified to GMP again in 2006when its first certification was expired 5 years later, the GMP of 2010 Versionin 2011, and was successfully certified to GMP of 2010 Version in 2017 when itsformer certification was expired 5 years later. The production line is designedand built in strict compliance with the technological process of oral solidpreparation and Class D clean zone requirements. Thanks to its advancedequipment and high degree of automation, "four advanced productiontechnologies" , which refer to production process control, delivery bypipeline, automatic detection and mechanic packaging, have been truly realized.As a result, the quality of products is effectively ensured. Among itsequipment, CO2 supercritical extraction equipment, ultrasound oscillationextraction equipment, macroporous resin adsorption coupling unit, microwavevacuum decompression drying equipment, spray dryer, etc. are cutting edge athome and abroad. Many extraction and purification methods such as aqueous extract,alcohol sedimentation, CO2 supercritical extraction, ultrasound oscillationextraction and macroreticular adsorbent are applied. These methods have playedan important role in improving traditional production method of traditionalChinese medicine and quality of products, advocating technical innovation oftraditional Chinese medicine and building a quintessence brand of traditionalChinese medicine. The annual production capacity ofthis production line is 1000 tons.Theverification and daily monitoring of all workshops are carried out by strictlycomplying with relevant provisions in order to effectively ensure the productsproduced through production line are stable, homogeneous and controllable.Comprehensive automation has been adopted to thenewly-built Phase Ⅴproduction line.

Production line of chemical raw medicine

Production line of chemical raw medicine

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Productionline of chemical raw medicine in Pharscin Pharma was first certified to GMP byChina Food and Drug Administration in 2001, and was successfully certified toGMP again in 2006 when its former certification was expired 5 years later, andwas successfully certified to GMP of 2010 Version in 2011, and was successfullycertified to GMP of 2010 Version in 2017 when its former certification wasexpired 5 years later. The production line is designed and built in strictcompliance with the technological process of oral preparation (crude drug) andClass D clean zone requirements. Thanks to its advanced equipment and highdegree of automation, "four advanced production technologies" , whichrefer to production process control, delivery by pipeline, automatic detectionand mechanic packaging, have been truly realized. As a result, the quality of productsis effectively ensured. Among equipment in this company, ultra-low temperaturecrusher and high-efficiency boiling dryer are cutting edge at home and abroad. The application of ultrafine low-temperaturepulverization technology has improved the dissolution effect andbioavailability,taking product quality to a new high.The annualproduction capacity of this production line is 200 tons.The verification and daily monitoring of all workshopsare carried out by strictly complying with relevant provisions in order toeffectively ensure the products produced through production line are stable,homogeneous and controllable.


Synthetic production line

Synthetic production line

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Synthetic production line in Pharscin Pharma was newlybuilt in 2012, which was successfully certified to GMP of 2010 Version in 2017.This production line is mainly used to produce thenewly researched and developed high-tech crude drug. This production line isdesigned and built by strictly complying with relevant requirements of oralpreparation (crude drug) and Class D clean zone requirements. Advancedinternational concept is also applied to the whole process of this productionline. With its advanced equipment and high degree of automation, the new highefficiency production featured production and operation process control,supplies delivery by pipeline and automatic detection of products have beenrealized.The daily management of whole production line iscarried out by strictly referring to GMP of 2010 Version. Therefore, theresearch of new medicine is more scientific and controllable, which in facthelps Pharscin Pharma to move forward more successfully.

Newly-built production base

Newly-built production base

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Atpresent, with the increasing development of the company, a new production baseof Pharscin Pharma occupied more than 160 mu is being built. Based on original11 production lines, a production line for Chinese herbal slices, animal houseand overhead automated warehouse are newly increased. Thenew production base will be designed and built in strict compliance withrequirements of EMA and FDA. An independent air conditioning purificationsystem is adopted to strictly separate chemical drug from traditional Chinesemedicine.The international first-classproduction equipment is used in the newly built production base. Internationaladvanced technologies such as automatic appliance cleaning system, automaticweighing and batching system, automatic input and output system, isolationsystem, on-line monitoring system, intelligent robot packing and palletizingsystem and sterilization system of space vaporized hydrogen peroxide, dustlessintelligent conveying system for material in workshop, intelligent materialtransfer system for workshop and warehouse are also applied to this productionbase. As a result, digitization, automation and intelligent manufacturing areactually realized in full.

Quality control

Quality control

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Aspecial quality management institution has been established in PharscinPharma.----quality management center, which is subdivided into qualityassurance department and quality control department, and is led by the generalmanager directly. The quality management centerwill independently exercise its rights and duties granted by Pharmaceutical Administration Law, Criterions for the Quality Control of DrugManufacturing (GMP), in an effort to continuously improve and perfect thequality management system.As far as thesociety is concerned, we have always committed to the mission that rejuvenate national pharmaceutical, manufacture quality medicine, and safeguard for health. As far asthe patient is concerned, we adhere to the principle that satisfies customers.As far as the product is concerned, we strictly implementinternal standards which arestricter than legal standard. As far as the employee is concerned, we haveorganized kinds of quality activities and training in order to improveemployee's quality awareness and operating skills. As far as the supplier isconcerned, we have also proposed corresponding requirements to guaranteequality of products from the beginning.


Thequality control department takes up an area of more than 1700 square meters.The original prices of kinds of detecting instruments, equipment and facilitiesare more than RMB 10 million yuan. The departmenthas equipped with latest and modern large-scale detection and analysisinstruments such as infrared detection instrument, ultraviolet detectioninstrument, gas chromatography detector, high performance liquid chromatographydetector, spectroscopic instrument, ion chromatography detector, atomicabsorption detection instrument, etc. Complete data tracing system of onlineedition is also established.All personnelin the quality control department have acquired a college degree or above inrelevant professions and have taken the post after being assessed by theChongqing Pharmaceuticals Quality Association. With rich experiences intheoretical knowledge analysis and working, they have laid a solid foundationfor the quality assurance.


It is the precise, careful, standard and scientific quality management and serious, persistent, responsible and efficient work style that make common people feel assured of its quality medicine. The qualification rate of all its market products has reached 100% in the course of national drug market sampling inspection, supervision and sampling inspection carried out by the Chongqing Food and Drug Administration, sampling inspection and delivery inspection carried out by the Chongqing Institute for Food and Drug Control since the establishment of the company. The company has been awarded the "Excellent Quality Management Team in China's Medical Industry". The company has been also rated as the "Satisfactory Enterprise of Chongqing Users" by the Chongqing Municipal Bureau of Quality and Technical Supervision and Chongqing Quality Control Association. Products manufactured by the company such as Weidimei(Hydrotalcite Tablets), Luoxuanzao Jiaonang are rated as the " Brand Products of Chongqing". Besides, the Terazosin Hydrochloride Capsules and Macrogol 4000 Powder produced by the company are rated as the "Consumer Trust Products".