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1、Page 17/28Site Master FileIssue Date: 1/8/2009Issue No.: 001SITE MASTER FILESign./DatePositionNameQA ManagerComplied ByPlant ManagerApproved ByManaging DirectorAuthorized By1. GENERAL INFORMATION1.1. Brief Information About Pharmaceuticals Company: is a highly fast growing pharmaceutical company wit
2、h several production lines. It was established in 2000 under the investment law No. 8 for the year 1997.It is owned by a well reputed businessman in the medical and pharmaceutical fields, In zhejiang province china; Mr. , the chairman of the company.The capital money of the company is seven million
3、dollars. a very well experienced pharmacist in the pharmaceutical industries, is the Managing Director. in the first phase started manufacturing Empty Hard Gelatin Capsule, and different solid dosage forms pharmaceutical products (Tablets, Capsules and Effervescent products). The Empty Hard Gelatin
4、Capsule is produced according to the recent advanced technology of Empty Hard Gelatin Capsule production provided by Technophar -Canada, which is one of the largest company through out the world in the field of Hard Gelatin Capsule Technology . solid dosage forms production area is divided into two
5、major sections:a) Tablets (uncoated and coated) and Capsules .b) Humidity controlled area for the production of effervescent products.In the second phase, additional production lines for Liquid Syrups, Suspensions, Ointments, Creams and Lotions will be completed.In the third phase, Ampoules and eye
6、drops lines, and a separated antibiotics plant will be completed. recruited a very highly qualified staff with an academic background, and good experiences in the Industrial pharmaceutical field.Total number of employees is around 200. manufactures under cGMP rules and Regulatory regulations. Machin
7、es, equipment, services and processes had been validated to very high international standards.The quality policy of rhythm with the aims of the management to reach the motto. IT IS JUST A MATTER OF QUALITY1.2. Pharmaceutical manufacturing Activities:The Pharmaceutical manufacturing activity is licen
8、sed according to GMP regulations from the China Health Authority and Covered by manufacturing license 1.3. Other manufacturing activities:None1.4. Site Address:AddressTel. No.6705379 6705380 6705381Fax No.6705378Contact Person:* (Plant Manager)1.5. Type of products manufactured at the site:1.5.1. Pr
9、oduction of Empty Hard Gelatin Capsules.1.5.2. Pharmaceutical Dosage Forms Products (Capsule, tablets, Powder Sachets and effervescent Sachets).1.5.3. None of the products Produced at the site is toxic or hazardous.1.6. Short Description of the site:The site is located at the free industrial zone at
10、 Nasr City. Total site area is about 2500 m2 with built up area of about 2000 m2. No activities other than manufacturing of hard gelatin capsules and Pharmaceutical dosage forms are carried out at the site.1.7. Numbers of employees engaged in the manufacturing activities:Production39Quality Assuranc
11、e2Quality Control8Research and Development1Warehouse & Material management5Engineering 21Planning1Administration21Total981.8. Use of outside Analytical or manufacturing Assistance:Not applicable.1.9. Quality Management System is committed to ensure that all manufactured products meet the pre-set sta
12、ndards of quality, efficacy and safety. believes that this can be only guaranteed through holding a highly efficient quality management system based on current GOOD MANUFACTURING PRACTICE and International Quality Assurance Standards.We believe that human resources are the most valuable resources we
13、 have , so investment within this resources through efficient training and providing the most suitable environment to perform there jobs is our major concern . Health and social care are provided for all our employees. The Quality Assurance has a great role in the development and maintenance of the
14、companys quality system. This is achieved by a combination of systematic sampling, testing, validating, monitoring and auditing of materials, facilities, systems and procedures which can influence the quality of our products.Authorized and approved standard operating procedures for all operations ar
15、e used. This includes , production , quality control , quality assurance , materials management , warehousing, distributing , safety controls , housekeeping , sanitation , and engineering . Quality assurance has to ensure that these procedures are adhered and records are maintained. Any deviation is investigated and documented .Corrective action is taken wherever necessary. Periodic self inspection and auditing are conducted to monitor the effecti
