Pharmaguidances

SOP ON HANDLING OF OUT OF SPECIFICATION (OOS) PURPOSE To establish a procedure for evaluation and handling of ‘Out of specification (OOS)’ test results identified by Quality Control department. SCOPE This SOP covers procedure involved in investigation of out-of-specification (OOS) results pertaining to Starting materials, Packaging materials, finished products, in process samples and stability samples, … Read more

SOP ON INVESTIGATIONS PURPOSE This Standard Operating Procedure (SOP) defines the requirements for reporting, documenting, investigating, evaluating, managing, resolving and approving closure of investigations from cGxPs, approved specifications and/or procedures. SCOPE This standard applies to Investigations related to quality related events that occur from cGxPs, approved specifications, and/or procedures including but not limited to Protocols, … Read more

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 … Read more

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, … Read more

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 … Read more

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 … Read more

SOP ON PRODUCT RECALL AND MOCK RECALL PROCEDURE PURPOSE :  To define the procedure for drug product recall and mock recall. SCOPE  : This SOP shall be applicable to, Hold and/ or recall of drug products from distribution or market due to certain non- confirmatory aspects or instruction from regulatory agency. Hold and/ or recall … Read more

SOP ON 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 … Read more