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Quality by Design

As per the quality policy Beijing Sciecure Pharmaceutical Co. Ltd. (Sciecure) develops, manufactures and sells high quality products for Chinese and international markets keeping in mind that “Quality by Design” (QbD).

Understanding and implementation of appropriate quality management system model enables Sciecure to fulfill its ethical as well as regulatory responsibility of management of identity, quality, safety, purity and efficacy of finished medicinal products.

Sciecure has quality management system that encourages the use of science- and risk-based approaches to take care of different stages of a product life cycle.

Sciecure has state-of-art automated facilities to develop and manufacture API, formulation development, analytical development, pilot plant scale-up, manufacturing of sterile injectable (liquid as well as lyophilized products), oral solid dosage (tablet and capsules). The facilities are supported by:

QC laboratory for:

The sampling and testing of all active pharmaceutical ingredients and excipients

Testing of intermediates, pharmaceutical water, environmental control and finished products

The state-of–art sophisticated instruments to continuously perform the quality tests to ensure the quality of raw 
materials, in process intermediate and final product, to meet required specifications


QA for:

Establishing and improving the company’s quality management system

Assigning the sole duty of staff to monitor namely, assessment of suppliers (vendors), procurement and inspection of 
the raw materials (starting materials) prior to receipt at warehouse.

Sampling of intermediates, pharmaceutical water and water for injection (WFI), environmental control 
(active and passive air sampling) , and finished products

Monitoring the whole production process, product releasing, product transportation and customer feedback 
(market complaints)

Self-inspection and routine customer/regulatory inspections as well as the summary compliance reports

Improvement of quality system in accordance with cGMP philosophy required as per the regulations of namely, 
Chinese FDA,USFDA, MHRA and EU

Responsible for continuous trainings to all employees to ensure the implementation of quality concept

Strict adherence to data integrity policy by each of the employees and principles of ethical conduct


Quality group is mainly composed of QC, QA, Validation, Metrology & Calibration, Documentation to exercise for the quality testing, monitoring and management respectively.

Validation team who works on validation of manufacturing process for decreasing the cost, optimizing process to provide a high degree of assurance that all manufacturing processes will consistently produce products meeting their pre-determined specifications and quality attributes. Validation Department will set the validation master plan and organize the prospective validation, concurrent validation,retrospective validation, re-validation, cleaningvalidations, and qualification/re-qualification of equipment/instruments.

Metrology & Calibration Department is responsible for management of all measurement procedures, implementation and execution of monthly and annually calibration/qualification plans, for instruments, meters and measuring equipment. 

Sciecure has passed more than 13 times the inspection by CFDA since it is established; the workshops (manufacturing units) for small volume injection and lyophilization were granted GMP certificates (2010 version) from CFDA. Currently Sciecure is preparing for the inspection from MHRA, EU and FDA for the production lines of sterile injections (ampoules/vial), lyophilized products and oral solid dosage (tablets and capsules) triggering from the various dossiers submissions (some of them already filed and some are in progress).

The company has established cGMP quality management system which is complying with the requirements of international standard. The company performs internal control standard that is stringent than national standard, strictly controlling the production process management, implementation of GMP management during the whole production process. We use international advanced brand equipment/instruments to produce high quality products and test finished products. We also inspect and have controls on intermediate and finished product to ensure product quality.

The policy of company is selling and producing high quality pharmaceutical dosage. Sciecure executes the whole process strictly accordance with the GMP requirements for management and controlling from starting material supplier to after sales service, and constantly improve our quality system to ensure product quality and safety.


BeiJing Sciecure Pharmaceutical Co. Ltd., Contact info: 010-60447688 Address: Zhongbei Industrial Park, Beishicao Town, Shunyi District, Beijing, China.