OBJECTIVE : To provide the guidelines for investigation, root cause analysis, their evaluation and corrective actions to prevent recurrence. SCOPE : This procedure is applicable for a common failure investigation root & cause analysis process for the failure occurs in set product, process and quality ...

Objective: To provide guidelines to record, check, evaluate and summarize the incidence. Scope: This procedure is applicable for handling of incidence during manufacturing activities of exhibit, validation and commercial batches at (Company Name). Responsibility: 1. Operator / supervisor shall be responsible ...

Objective: To describe the procedure for maintaining signature log of all personnel working in GMP related activities. Scope: This SOP is applicable for all department personnel working in (Company Name). Responsibility: 1. Concerned department shall be responsible for preparation and timely updating ...

• Introduction • Scope • References • Team Involved in the Validation Review • Equipment Details • Equipment Qualification Protocol / Report Reviewed • Equipment Qualification Protocol / Report Review Summary • Equipment Used for the Products • Equipment Performance Review • Change ...

Design Qualification (DQ): documented verification that the proposed design of the facilities, equipment, or systems is suitable for the intended purpose. Installation Qualification (IQ): documented verification that the equipment or systems are installed or modified & comply with the approved design ...

Objective: To describe the procedure of batch numbering system for common blended granules & finished products. Scope: This procedure is applicable for the common blended granules & the product batches manufactured in (Company Name). Responsibility: 1. Production planning personnel 2. Production ...

Critical defect : Critical defect are those defect which can be life-threating & which require the company to take immediate action by all responsible means as soon as the defect becomes apart whether in or out of business hours. Example : 1. Products labeled with incorrect name. 2. Counterfeit ...

Root cause analysis is performed to determine the root cause of errors or problems during the process. Root causes of out-of-specifications, production time deviations, and market complaints must be determined. Various methods are used for root cause analysis in pharmaceuticals. 5 Why is a useful and ...

Objective: To ensure adequate process control at every stage-Receipt of materials, Manufacturing and Packing so as to get the Drug Product (Finished Product) as per required specification. Scope: This procedure is applicable to all Production activities such as Manufacturing, Packing (Tablet & ...

OBJECTIVE : To provide information regarding the tamper evidence features appropriate for various types of packs. SCOPE : This procedure is applicable to all product packs in (Company Name). RESPONSIBILITY : It is the responsibility of QA Department, to follow the instructions as stated in this procedure. It ...