Good Documentation Practices (GDP) in Pharmaceutical Industry

By Chandrasekhar Panda

Good Documentation Practices (GDP) in Pharmaceutical Industry document contains the the instructions which are required to be followed for compliance of Good Documentation Practices (GDP) during preparation, data entry, recording and reporting of all types of documents in the plant. This is the basic requirements for the persons working in pharmaceutical industry.

• Language: English
• Publisher: Chandrasekhar Panda
• Release date: Jan 11, 2024
• ISBN: 9798224099382

Chandrasekhar Panda

The Author of this Book is Mr Chandrasekhar Panda with Educational Qualification of Bachelor of Pharmacy with more than 17 years of Experience in Pharmaceutical Industry Quality Assurance.

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Objective :

To lay down a Procedure for Good Documentation Practices (GDP).

Scope :

The scope of this document is to provide the instructions to be followed for compliance of Good Documentation Practices (GDP) during preparation, data entry, recording and reporting of all types of documents in the plant.

3.0  Responsibility :

3.1  All Plant Personnel: To follow the Procedure for Good Documentation Practices.

3.2  Concerned Department Personnel: To raise the Request for Document Rectification as and when required to correct minor mistake in master / controlled / executed documents.

3.3 Concerned Department Head / Designee: To review the Request for Document Rectification.

3.4  Quality Assurance (QA) Personnel: To review and monitor compliance of the Procedure for Good Documentation Practices and to make correction in master / controlled / executed documents based on approved Request for Document Rectification.

3.5   Quality Assurance Head / Designee: To approve / Reject Request for Document Rectification.

4.0  Definition(s) :

4.1