Review on Good Documentation practice in pharmaceutical manufacturing unit as per European Union GMP Chapter-4 on Documentation

  • Suleman S khoja Ganpat University
  • L J Patel Ganpat University
  • Sohil S khoja Pharmaceutical Quality Assurance, Audit and Compliance
  • Karim R Panjwani Pharmaceutical Quality Assurance, Audit and Compliance
  • Jagdish Ray Pharmaceutical Quality Assurance, Audit and Compliance
Keywords: Good Documentation practice, European Union, GMP

Abstract

Good documentation constitutes an essential part of the quality assurance system and is key to operating in compliance with GMP requirements. Documentation requirements of maintaining complete, accurate, truthful and verifiable data in all cGXP documents that are needed to be maintained as per regulatory requirements and various Governmental regulations, laws, rules and statutes/acts. Documentation may exist in a variety of forms, including paper-based, electronic or photographic media. Ensure that the Document should be free from error and during any point if error identify then rectify with proper reason for correcting including sign and date. A system should be in place to indicate special observations and any changes to critical data. GMP Document must have predefined retention period and document must be stored in secure and easy to retrieve or easily available as and when required. Batch Processing and Packaging Instruction must be in place and Contemporaneous entry provision must be available. Instruction and procedure for using equipment; instrument must be clear and specific. Specification with authorization should be available for analysis of Raw Material and Packing Material, Intermediate and Bulk Product, Finished Product.

Author Biographies

Suleman S khoja, Ganpat University

PhD. Research Scholar,
Ganpat University, Mehesana, Gujarat, India

L J Patel, Ganpat University

Faculty of Pharmacy,
Ganpat University, Mehesana, Gujarat, India

Sohil S khoja, Pharmaceutical Quality Assurance, Audit and Compliance

Resource person, Pharmaceutical Quality Assurance, Audit and Compliance,
Vapi, Gujarat, India

Karim R Panjwani, Pharmaceutical Quality Assurance, Audit and Compliance

Resource person, Pharmaceutical Quality Assurance, Audit and Compliance,
Vapi, Gujarat, India

Jagdish Ray, Pharmaceutical Quality Assurance, Audit and Compliance

Resource person, Pharmaceutical Quality Assurance, Audit and Compliance,
Vapi, Gujarat, India

References

EudraLex Volume 4, Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Chapter 4: Documentation Effective 30 June 2011.

MHRA Presentation - Good Documentation Practice a refresher Session 2, 2018.

Published
2019-01-01
How to Cite
[1]
khoja, S., Patel, L., khoja, S., Panjwani, K. and Ray, J. 2019. Review on Good Documentation practice in pharmaceutical manufacturing unit as per European Union GMP Chapter-4 on Documentation. PharmaTutor. 7, 1 (Jan. 2019), 1-4. DOI:https://doi.org/10.29161/PT.v7.i1.2019.1.
Section
Articles