Overall Quality planning and monitoring.
Writing, updating and implementation of Quality Systems/Manual.
To set systems which have a bearing on quality.
To approve new products for launch.
To approve Quality Control procedures.
To approve minor changes/deviations, design changes.
To initiate actions arising out of quality complaints and to resolve non-conformance.
To initiate and oversee product recall
To audit, validate and certify vendors.
Approving and issuing of raw and packaging material specifications.
Carrying of process control defect analysis and decide with production the corrective actions.
Monitoring stability of all running products and new products.
Brief Information on XIEON Life Sciences Pvt. Ltd.:
XIEON was established in the year 2006 with the prime objective of Manufacturing, Marketing, Promoting of Pharmaceutical Specialities and making medicines available also to the man-kind living in the farthest interior and remote places. Last one year the Company has made progress and is today a leading medium scale Pharmaceutical Company in the area of Health Care.
The Board of XIEON has adopted a policy of operating the pharmaceutical manufacturing under the control of a Quality Management system, installed and operating as stated in the Quality Manual. The purpose of the policy is to ensure that all strict measures/standards, which are legal as well as jointly, set by the customer and our own company are adhered and followed. It is also our policy to update the standards as per cGMP. and customer requirements by means of mutual dialogue.
The Quality Control Department is fully authorized to take appropriate decisions on quality matter.
Firm's Quality Policy:
In the pharmaceutical industry, consumer protection assumes special significance because the purchaser of a drug product has no way of knowing whether the medicine/drug he has purchased and intends to use will be safe and effective. With a view to maintaining quality of our products XIEON has adopted a policy of operating the pharmaceutical manufacturing under control of a Quality Management System installed and operating as stated in the Quality System Manual. The purpose of the policy is to ensure that all strict measures and standards which are legal as well as jointly set by the customer and our own company are adhered and followed.
Responsibility of the Quality Assurance function:
Nature of Business:
Manufacturer of Pharmaceutical formulation in various dosage forms under various categories.
1. Tablets Beta-Lactam & Non- Beta-Lactam group products
2. Capsules Beta-Lactam & Non- Beta-Lactam group products
3. Ointment, Lotion and Solution
4. Syrups and Suspensions (Liquid Orals)
5. Dry and liquid injection
Under the category:
1. Antibiotics and Anti-infective
6. Various Vitamin preparations.
Apart from the manufacturing activities the company has its own independent laboratory equipped with all required equipment’s and is capable to test all types of Raw materials, Packing Material, Semi-Finished Products and Finished Products. The Quality Control laboratory is divided into the following sections:
1. Chemical and Biochemical Sections
2. Instrumentation Sections
3. Sophisticated Instrument room
4. In-Process Control Section
5. Research and Development Sections