PHARMA GUIDE

* It is a procedure to ensure that the manufacturing products to a defined set   of quality criteria. * Quality control is that part of GMP concerned with sampling, specification,   testing, documentation and release procedures. * Which ensure that the necessary and relevant tests are performed and the   product is released for use only after ascertaining its quality. * Resources: Adequate facilities              Qualified personnel              Approved written procedures. * Tasks: Sampling       Inspecting               Testing               Releasing or Rejecting               Monitoring * Objects: Starting materials                  Intermediates                  Bulk and Finished products                  Returned products                  Environmental conditions. * Role and Responsibilities: * Examines approves or rejects incoming materials, intermediates, bulk, finished products   and returned products. * Does the inspection during production(i

* Here we are discussing about Role and Responsibilities of QA officers in Pharma industry. * Ensure SOP's are available for all the quality related activities and they are current. * Approving procedures like sop's specifications, the method of analysis, bpcr's, master formula and forms. * Ensure internal audits are carried out as per schedule and necessary corrective actions are taken. * Ensure changes are handled properly and co-ordinate with regulatory affairs dept for speed approvals. * Preparations of master validation plans and review and approval of validation protocols and reports. * Handling of customer complaince. * Ensure maintenance and calibration and validation of equipment/instrument is carried out as per schedule. * Preparation of annual product quality review reports. * Ensure proper archiving and retrieval of documents. * Ensure external audits complaints. * Ensure vendor qualifications. * Ensure that training needs of all departme