1.0 PURPOSE: To define a procedure for control of data integrity issues at manufacturing location. 2.0 SCOPE : 2.1 This procedure applies to all the employees working in all the departments and applicable to all GMP documents throughout its lifecycle, of …………….. 3.0 REFERENCE(S) & ATTACHMENTS 3.1 ...

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 a procedure to evaluate a potential new source or to monitor ongoing quality on a routine basis for existing vendors. 2.0 SCOPE This SOP shall be applicable to all vendors manufacturing raw & packaging materials supply to the BPL. 3.0 ASSOCIATED DOCUMENTS Not applicable. 4.0 ...

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 The objective of carrying out Product Quality Review (PQR) is to establish that the product is manufactured as per approved procedures and the trends of results of critical quality attributes are well within acceptable limits. PQR will also address the review of raw and primary packaging materials ...

To lay down the procedure for facility qualification Responsibility: > Engineering Manager or his/her designee will be responsible for initiating facility qualification. > Validation manager will be responsible for checking sufficiency in protocols and reports and requirement of facility qualification ...

Objective: To set up a procedures for crimping strength test for all semi-finished products. Scope: This procedure is applicable for semi-finished products manufactured at MDI unit, (Company Name). Responsibility: 1. IPQA Officer shall be responsible for sampling and testing of semi-finished products ...

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 ...