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QUALITY MANAGEMENT SYSTEM


The Management is committed to the development and implementation of the quality management system. The effectiveness and continual improvement of quality management system is being monitored.

The employees are trained in respective functional areas depending upon their qualification, experience, area of working and assigned functions of individual. They are trained in relation to their particular function, which complies with cGMP.

Self-inspection programmes to ascertain the compliance with the GMP requirements. The standard operating procedures are prepared and followed.

Quality Assurance inspector carries out shop floor inspection in order to ensure compliance with the standard operating procedures (S.O.P.) and instruction in batch manufacturing records (B.M.R.). In-process inspection and analysis is carried out to ensure that the product is manufactured as per the S.O.P. and B.M.R. cGMP is being adhered to and product conforms to the specification.

A team of Q.A. personnel and production personnel audits vendors of raw and packaging material and their observations are documented as per S.O.P.

Raw material and packing material are received as per S.O.P. They are Quarantined and entered in the stock registers and “QUARANTINE” label is affixed. The intimation is given to Quality Control department through GRN. They are sampled as per the Sampling plans as given in the SOP and analyzed as per Pharmacopoeial standards and in - house specification.

If the material complies with the specifications then the Q.C. department releases the approval of the materials by affixing a status label “APPROVED” to the raw and packing material containers. These procedures are carried out as per the S.O.P.

The testing of the finished products is carried out as per the S.O.P. Each sample is tested as per the finished product specification. Relevant approvals are sent to respective production department to bulk product and to finished product store. If the batch fails, it is kept under “HOLD” and laboratory failure investigation is carried out. Finished pack samples are also tested for batch coding and other details.

Product release: After the completion of the batch packing by the packaging department the product is transferred to the “FINISHED PRODUCT QUARANTINE”. Q.A. department checks and verifies all the documents of that batch and gives “RELEASE” to the finished good stores for the distribution and sales.

At Sparsh Bio-Tech Pvt. Ltd Quality Assurance & Quality control are individual department with full authority to approve or Reject anything, which they feel is not according to cGMP.