1. OBJECTIVE • To describe the procedure for handling of deviations. • To lay down the investigation and control procedure for deviation, which can affect the quality of the product, to enable a suitable and prompt action. 2. SCOPE • This SOP is applicable for any deviation in an established process ...

1. OBJECTIVE 1.1. Change control is a quality tool and a management to maintain and keep the records of all changes as a history. Changes can be related to facility, documentation, system, equipment, instrument, procedure, layouts and products etc. 1.2. To lay down a procedure to describe the handling ...

1. Objective 1.1. To lay down a procedure for data integrity as part of quality management system. 1.2. To establish guidelines and procedures to ensure data integrity in regulatory activities. 1.3. To prevent unauthorized access, loss, alteration, or falsification of data throughout the regulatory processes, ...

1.0 Objective To provide guidelines for the transfer of analytical methods for testing of raw materials and finished products to site laboratories where the routine testing shall be carried out including the training of the concerned analyst and proper documentation. 2.0 Scope This procedure is applicable ...

OBJECTIVE To review the Quality Management System implementation status and to plan for resolving any outstanding issue and for closing the gaps. SCOPE This SOP is applicable for holding Quality Management Review meeting system in (Company Name). RESPONSIBILITY 1. Team members of concerned departments ...

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 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 ...

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 ...