Institute of Good Manufacturing Practices India
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Approved by Quality Council Of India (QCI), Government of India
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Empanelled under Ministry of Horticulture and Food Processing, Government of Uttar Pradesh
International Register of Certificated Auditors (IRCA) accredited Lead Auditor (FSMS) course
Affiliated with Life Sciences Sector Skills Council (SSC) and Food Industry Sector Skills Council set up by National Skill Development Corporation (NSDC)
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A Draft Guidance for "Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments" was released from PIC/S.

A Draft Guidance for "Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments" was released from PIC/S. "Data Governance" means the sum of all measures taken to assure data integrity. In Chapter 5 of draft guidance, a description was given about “what a Data Governance system means for authorities and what requirements result from it for pharmaceutical companies”. The data governance system should be integrated into the pharmaceutical quality management system, which should guarantee that data are handled completely, consistently and accurately over the whole data lifecycle from beginning of their creation up to their deletion. This also includes the data ownership. Both organisational and technical controlling measures are proposed and the organisational controls include:

• Procedures for completion and retention of completed paper data
• Training of employees about documented authorisation for data generation and approval
• Data governance system design with effective controls
• Regular verification of data and periodic surveillance of the data governance policy
• Periodic reviews should be performed as part of self-inspections (internal audits) or periodic monitoring of the processes.


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