GMP Guru

Your GMP knowledge resource hub.

We publish informative articles on GMP periodically. GMP professionals can use them as resources. We welcome your suggestions.

We are publishing a series of 8 informative articles – 2 per month – containing compilation of WHO GMP Audit Findings Collected from WHOPIR of 28 companies.
These articles are written by A. Jwalakant, an experienced pharma professional and meritorious student of Insights Professional Management Academy, Pune, Diploma in GMP XIII th batch.

A Compilation of WHO GMP Audit Findings Collected from WHOPIR of 28 companies

A Compilation of WHO GMP Audit Points - Part I

– by A. Jwalakant (PDF – 632 KB)

A Compilation of WHO GMP Audit Points - Part II

– by A. Jwalakant (PDF – 553 KB)

A Compilation of WHO GMP Audit Points - Part III

– by A. Jwalakant (PDF – 509 KB)

A Compilation of WHO GMP Audit Points - Part IV

– by A. Jwalakant (PDF – 779 KB)

A Compilation of WHO GMP Audit Points - Part V

– by A. Jwalakant (PDF – 618 KB)

A Compilation of WHO GMP Audit Points - Part VI

– by A. Jwalakant (PDF – 582 KB)

A Compilation of WHO GMP Audit Points - Part VII

– by A. Jwalakant (PDF – 689 KB)

A Compilation of WHO GMP Audit Points - Part VIII

– by A. Jwalakant (PDF – 607 KB)

Article archive

Out of Calibration

By GQCLP expert Srikant Nitalikar, Quality Head at Glenmark Ltd., Goa (PDF – 387 KB)

The Human Capital Management Model

By Shri Atul Shirgaokar released in a book at the HR Conclave during February 2012 (PDF – 738 KB)

A short presentation on DOE

By R&D expert Dr. Chintamani Bapat (PDF – 414 KB)

FDA enforcement trends 2010

By Shri Madhu Raju Sagee, a young dynamic author and GMP resource(PDF – 675 KB)

Quality yesterday, today tomorrow

By renowned management Guru sri Sharu Rangnekar(PDF – 40 KB)

TSE/BSE Risk Regulations in pharma industry

(PDF – 1.1 MB)

Project Management in Pharmaceutical Industry

(PDF – 1.1 MB)

Risk Management - Future of Quality

By Greg Hutchins (reproduced with permission from Greg Hutchins)

Validation of Analytical Methods used for the Characterization, Physicochemical and Functional Analysis and of Biopharmaceuticals

By Dr. Nishodh Saxena – General Manager ( QA & RA ) Zydus Biologicals, Ahmedabad.

Risk assessment tools for environmental monitoring

By renowned microbiologist Tim Sandle.

Disclaimer: The views expressed in the articles above are solely those of the author of respective articles and do not necessarily express the views of the owner of this website and the website owners are not necessarily in complete agreement with the same.