Quality Management Systems at Shelys.
Shelys has a well-established Quality Management System that ensures that the products that reach the consumer are safe, efficacious and effective. At Shelys the quality system is driven by a competent Pharmacist who is the Head of Quality Assurance Department. All the other personnel in this department are well educated and have a lot of experience in this field. Under this department, there is the cGMP compliance, Quality Control, In-process control, Regulatory Affairs, and Research and Development .
The cGMP Compliance Pharmacist ensures that all procedures in all the departments and records are adhered to and evaluated every month and corrective action taken. The different processes are documented in the form of Standard Operation Procedures (SOP). cGMP Compliance Pharmacist also ensures that all validation of equipment, process and analytical procedures are done and they are compliant.
Shelys has a well established Quality Control Laboratory. It is well equipped with all the necessary equipments such as High Performance liquid Chromatography (HPLC), UV/Visible Spectrophotometer, FTIR Spectrophotometer, dissolution tester and many more. The QC has the responsibility of sampling and testing all the raw materials, packing materials and all the manufactured products to ensure that they meet the respective pre-determined specifications. Sampling and testing of all the materials is done on each and every batch. The release of materials for use in production and the release of products for sale is done by the Quality Assurance Manager after ensuring that that the product meets with all the specification at all the stages.
The In process controls are the tests done on the production floor as manufacturing is going on to ensure that the products meet specifications as the production progresses. Line clearance is also mandatory to ensure that no batch gets any cross-contamination.
New product Development is the lifeline of a company. Shelys invests well in the New Products Development to ensure that the products meet the requirements of our esteemed customers. A vigorous due diligence is done on all our new products to ensure that we only have quality products. To this end, the Quality Assurance Department is charged with the responsibility of ensuring that the suppliers and the contract manufacturers are all Good Manufacturing Practice (GMP) Compliant before the products are placed in the market.
The regulatory Affairs is also under the Quality Assurance Department. The Regulatory Affairs deals with the different Regulatory Authorities in the different countries where BHIL products are sold. This ensures that the products are registered in all the markets. All the products that are sold in the different regions comply with the specific requirements of each of the regions.
The warehousing facilities are also monitored under the QA system to ensure that raw/packaging materials and the finished goods are received, stored and dispatched as per the laid out procedures.