Shineway Pharmaceutical: Pharmaceutical Excipients management "strictness" - Pharmaceutical Excipients - Pharmaceutical industries
Shineway Pharmaceutical: Pharmaceutical Excipients management "strictness" - Pharmaceutical Excipients - Pharmaceutical industries
Shineway Pharmaceutical is a large modern country Chinese medicine injection , Soft capsule, granule production enterprises, as the divinity of one of the main formulations Herbal Injection , High technology, high quality standards, quality control is very high difficulty. Shineway Pharmaceutical always adhering to the "great quality" concept, implementation of strict management, from Medicine And raw and auxiliary materials, production, testing, distribution and use of each link are strictly controlled to ensure product quality. Pharmaceutical Excipients The management has been an important part of quality control of divinity, divinity in Accessories Management highlighted a "serious" character.
"The quality of excipients Drugs Bioavailability, stability of finished products have a major impact. "Shineway Pharmaceutical Co., Ltd. Chairman Li Zhenjiang that auxiliary selection and design aspects from the pharmaceutical R & D Start, Shineway Pharmaceutical R & D in the drug design process, product quality and safety put first, the choice of accessories as R & D An important part of the project to give overall consideration. Select the main drug activity and the main detection method did not affect drug accessories, and small-scale test, test, stability test, pharmacological research, by large amounts of data to select the product quality standards, storage of stability, safety of pharmaceutical excipients.
Rigorous screening gifted, good supplier credit is Shineway Pharmaceutical standard use of an important aspect of pharmaceutical excipients. Liying Li Shineway Pharmaceutical Quality Assurance Manager, said, companies have quality management extends to suppliers, select large, strong technical force, gifted accessories manufacturer. Enterprise suppliers to develop a strict audit requirements and auditing standards, supplier qualifications to ensure license compliance, by the quality department, audit department, production department of the manufacturer's on-site co-production, quality management review, comply with GMP Pharmaceutical Excipients requirements may choose to suppliers. Suppliers by the quality of existing departments, the audit department, purchasing department, production department combined regular quality audit, the audit will include: compliance with GMP requirements; the accessories for compliance with quality standards for incoming inspection requirements; in the course of quality is stable. If the above content to meet the requirements, can continue as a qualified supplier supplier, the audit does not meet the requirements, supplies, inconsistent quality or product quality is unstable, then the firm out.
In addition, the Shineway Pharmaceutical has established supplier records, including supplier qualification certificates, on-site audit reports, quality standards, product approval documents, the annual inspection of pharmaceutical excipients, shop use, product stability conditions, etc. annual comprehensive evaluation of suppliers. Strict supplier rating system, according to the situation of product quality and credit evaluation.
Same time, they also signed with the quality of pharmaceutical excipients supplier agreement, the agreement is attached to the line in quality Shineway Pharmaceutical quality standards for suppliers in strict accordance with standard delivery. Suppliers to implement the flight inspection system, no advance warning, directly to the site to conduct surprise checks, failed to cancel the supply of qualified and blacklisted.
Many suppliers said, and divinity Cooperation Demands very high, supply can not have the slightest problem. But this reason, cooperation with the divinity can sharpen their management and quality. Shenwei medicine attaches great importance to the daily communication with suppliers, often the quality of their product training to help providers improve the level of enterprise management and quality control. Supplier General Assembly annual meeting, strengthening quality requirements, enhance communication and collaboration.
In the test session, Liying Li, said, Shineway Pharmaceutical investment 100 million yuan building a laboratory certified by the State Quality Inspection Center. Quality Control Department has a dedicated auxiliary test group, all in the approach to conduct rigorous testing of raw materials, qualified only after production. Pharmaceutical Excipients business practice standards higher than the national pharmaceutical enterprise internal control standards, all incoming goods inspection Pipi, the validity period of the Pharmaceutical Excipients for use, the product of the invalid provision within the enterprise is valid for 3 years. Accessories in the library during the six months per year or sampling inspection, compliance before using. To stay in each batch of pharmaceutical excipients like, for drug use during or problems in the storage process can be timely inquiry, inspection.
Use links Shineway Pharmaceutical same strictly. All pharmaceutical excipients before use in feeding to conduct visual inspection, only after confirmation feeding, and the implementation of double review system, substandard medical supplements are not allowed. For injection drug use accessories in the feeding filter sterilization before treatment, to ensure product quality meets the requirements, use of safety. Unusual in the course of time sampling test confirmed the auxiliary problem, not into the next procedure, also include supplier evaluation system for evaluation and elimination.
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Shineway Pharmaceutical: Pharmaceutical Excipients management "strictness" - Pharmaceutical Excipients - Pharmaceutical industries Anaheim