– To approve or reject the Raw Materials, Packing Materials, In-process samples, Finished Product, Stability samples, Validation samples and working standard. Approval of certificate of analysis for the same.
– To ensure that the required initial and continuous training of department personnel is carried out and adapted according to need.
– Ensure to update standards operating procedures as per latest good manufacturing practices (GMP) guidance.
– To ensure the receipt and charging of stability samples, withdrawal, testing and release of samples as per schedule.
– To check and maintain department, premises, equipment, and instruments.
– Procurement of Chemicals/Glassware/Primary standards required for analysis.
– To ensure that all necessary testing is carried out.
– Review and approval of Specifications, Standard Test Methods, Analytical Data Sheets and Standard Operating Procedures, Stability protocols and Stability Summary reports, sampling instructions and other Quality Control procedures.
– To ensure that all required instruments are calibrated and meets the requirements of 21CFR part 11.
– To ensure that the appropriate validations are done.
– To ensure the compliance of the Microbiology department activities.
– Facing of Internal and External audits.
– Conducting of audits for contract testing laboratories.
– Participate in the investigation of Complaint, Product Recall and return goods.
– Responsible to give compliance for audit observations (if any).
– Recruitment of personnel in quality control.
– Evaluate the laboratory needs/requirements (i.e. New instrument/Equipment’s, sufficient manpower, appropriate working environment etc.) and arrange the same for smooth functioning of the activities
– Approval of 10/0Q/PQ protocols, and ensuring proper execution and compilation qualification data.
– Investigation of Out of specification (00S, Out of Trend (OOT)results) and Laboratory Incidents.
– Training and Evaluation of QC staffs and approval of analyst validation/qualification.
– Approval of User ID generated in laboratory software systems.
– Responsible to give compliance for audit observations (if any).