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 ...

Objective: To set up a review procedure for exercising control over the manufacturing of finished products so as to ensure the highest quality and to support the continual improvement of quality system at (Company Name). Scope: This SOP applies to finished products manufactured at all facilities of (Company ...

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 ...

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 ...

1.0 OBJECTIVE : To establish a procedure to determine holding time limits of intermediate materials/products, equipments, chemicals/reagents. 2.0 SCOPE : This procedure is applicable for all products to be manufactured at (Company Name). 3.0 RESPONSIBILITY 3.1 Production/Engineering department shall ...

1. Purpose: This defines the procedure for secondary gowning in sampling area. 2. Scope: This procedure is applicable for Secondary gowning and de-gowning in the sampling area. 3. References and Attachments: 3.1. References: None 3.2. Attachments: None 4. Responsibilities: 4.1. Personnel Department: 4.1.1. To ...

1.0 OBJECTIVE: To lay down the procedure for facility qualification. 2.0 SCOPE: All manufacturing, packaging, storage and other relevant area in (Company Name). 3.0 RESPONSIBILITY 3.1 Engineering Manager or his/her designee will be responsible for initiating facility qualification. 3.2 Validation manager ...