SOP FOR ASSIGNING ROLE AND RESPONSIBILITY
by 1.0 OBJECTIVE The objective of this Standard Operating Procedure (SOP) is: 1.1 To describe the procedure for preparation of roles and responsibilities of personnel …
Category: Quality Assurance
RETENTION AND HANDLING OF RESERVE SAMPLE (CONTROL SAMPLE)
1.0 OBJECTIVE To lay down the procedure to Retention and handling of reserve sample of finished product. 2.0 SCOPE This SOP is applicable …
RETENTION OF RECORDS
1.0 OBJECTIVE To describe the procedure for handling of records. 2.0 SCOPE This SOP is applicable for all the functions. 3.0 RESPONSIBILITY Quality Assurance …
GENERATION AND HANDLING OF INCIDENT REPORT
1.0 OBJECTIVE To describe the procedure for generation and handling of incident report. 2.0 SCOPE This SOP is applicable for the generation and handling …
HANDLING OF LOG BOOKS
1.0 OBJECTIVE To describe the procedure for handling of the log books. 2.0 SCOPE This SOP is applicable for procurement, issuance, usage and …
LINE CLEARANCE
1.0 OBJECTIVE To describe the procedure of Line Clearance given by In Process Quality Assurance (IPQA) personnel. 2.0 SCOPE This SOP is applicable …
QUALITY RISK MANAGEMENT
OBJECTIVE To lay down the procedure for risk identification, analysis, evaluation, reduction/ mitigation, communication and conclusion of risk in order to ensure the quality, safety, …
STATUS LABELING
Objective To lay down a procedure for the status labeling system & its control. 2. Scope This Standard Operating Procedure is applicable for identification labels …
STANDARD PROCEDURE FOR ASSURANCE OF DATA INTEGRITY
Objective The objective of this procedure is to provide guideline for the entry and control of data in all forms of documentation in a consistent …
SOP FOR CLEANING VALIDATION
Objective To Describe a Procedure for execution of Cleaning Validation Study. 2. Scope This SOP is applicable for execution of Cleaning Validation Study. …