Deviation Control OBJECTIVE: To lay down the procedure to describe the steps to be followed in case of planned/unplanned deviation from the standardized activity, or standard procedure. PROCEDURE : Deviations are of two types: Planned & Unplanned. Planned Deviation: Any Deviation in the procedure, process, equipment, or standard batch size which is planned, documented, assessed…
OBJECTIVE: To lay down the procedure for Change Control System. PROCEDURE: If anybody wants to make a change in the existing system and feels that the change will be fruitful in terms of productivity, and quality; he/she should discuss it with his / her department head. If the department head feels that it is required,…
Product Quality Review OBJECTIVE: To lay down the Procedure for preparation of Product Quality Review. PROCEDURE : Product Quality Review (PQR) is a mechanism to ensure that data captured by the Pharmaceutical Quality System (PQS) is reviewed for trends. This tool can support a continuous improvement environment. PQRs are designed for the purpose of identifying and…
Release of finished products OBJECTIVE: To lay down the procedure for the release of finished products. PROCEDURE : Ensure that the Batch Manufacturing Record has been reviewed and audited by Production in all aspects. The reconciliation of the materials and product yield is carried out at the respective stages of the operation. Ensure that the…
Product Recall OBJECTIVE: To lay down the Procedure for handling Product Recall. PROCEDURE: Recall: Recall means a firm’s removal of products from the market that considers being adverse reaction or in the case of patient safety, a violation of the law. Withdrawal: Withdrawal means a firm’s withdrawal, removal, or correction of a distributed product from…
JOB RESPONSIBILITIES OBJECTIVE To lay down the Procedure for preparation of Job Responsibilities. PROCEDURE To maintain a satisfactory system of Quality Assurance and manufacturing of drug products, as per cGMP requirements. Total operation is divided into various functions, called Departments. The following are the departments : Warehouse Production Engineering & Utility Quality Control Quality Assurance…
Welcome to WordPress. This is your first post. Edit or delete it, then start writing!