Quality control is responsible for sampling, testing and approve or rejection of active pharmaceutical ingredients, excipients, primary and printed Packaging materials, water treatment and waste water treatment systems, environmental monitoring of production areas and performing in process controls and preparing relevant documents according written and approved SOPs. Beside of Quality control of products and processes Q.C department is responsible for evaluation and release of critical steps of production.
The quality control department works independent of other departments and Directly Reports to QA Department.
The quality control department has other duties, such as to establish, validate, and implement all quality control procedures, evaluation, maintenance, and storage of reference standards, control of correct labeling of materials and products containers, stability monitoring of the active ingredients and products, to participation on validations and defect investigation programs of complaints related to the quality of the product, and participation in environmental monitoring programs. All these operations are carried out in accordance with written procedures.
Stability studies of products are carried out as per ICH guidelines at the stability study area, locates in the QC Department. Condition for stability study are defined as specification of each product.
For developed and existing products, stability is also studied under the specified storage conditions until the end of shelf life as specified, to confirm its ability to comply with the specifications set for the product. These are termed as ongoing stability studies. They are carried out on one batch per year as per the standard operating procedure for stability studies.