Audit and Guideline

USFDA WARNING LETTER 2014 (API)

Posted By: Pharmaceutical Guidanaceon: April 05, 2016In: Other TopicNo Comments

Novacyl Wuxi Pharmaceutical Co., Ltd. 12/19/14 Sharp Global Limited 10/15/14 CBSCHEM LIMITED 1/31/14 Read more

USFDA WARNING LETTER 2015 (API)

Posted By: Pharmaceutical Guidanaceon: April 05, 2016In: Other TopicNo Comments

Cadila Pharmaceuticals Limited 2/25/15 Sandoz Private Limited 10/22/15 Dr. Reddy’s Laboratories Limited 11/5/15 Zhejiang Hisun Pharmaceutical Co., Ltd. 12/31/15 Cadila Healthcare Limit... Read more

USFDA WARNING LETTER 2015 (Finished Pharmaceuticals)

Posted By: Pharmaceutical Guidanaceon: April 05, 2016In: Other TopicNo Comments

Advanced Physician Solutions, Inc. 11/3/15 Ionia Pharmacy 12/22/15 Hospira Spa 3/31/15 Triangle Compounding 11/2/15 Micro Labs Limited 1/9/15 Mylan Laboratories Limited 8/6/15 Sun Pharmaceut... Read more

Pharmaceutical Inspection Co-Operation scheme (PICS)

Posted By: Pharmaceutical Guidanaceon: March 31, 2016In: Link For GuidelineNo Comments

PIC/S GMP Guide (Last updated by PIC/S Secretariat on 12 February 2016) Documents for industry (PIC/S GMP Guide) PIC/S GMP GUIDE PE 009-12 Download PIC/S GMP GUIDE (INTRODUCTION) PE 009-12 D... Read more

Question & Answer on ICH

Posted By: Pharmaceutical Guidanaceon: March 31, 2016In: Question ForumNo Comments

Question and Answer on ICH Q7 Question and Answer on Q8 ,Q9 and Q10 For More Pharma Updates Visit –http://pharmaguidances.com Read more

WHO

Posted By: Pharmaceutical Guidanaceon: March 31, 2016In: PresentationNo Comments

Part 1 Management and infrastructure Part 2 Materials, equipment, instruments Part 3 Working procedures and safety Transfer of technology – Part 1 Transfer of technology – Part 2... Read more

WHO Guideline

Posted By: Pharmaceutical Guidanaceon: March 31, 2016In: Link For GuidelineNo Comments

WHO GUIDLINE FOR PRODUCTION WHO good manufacturing practices WHO good manufacturing practices for pharmaceutical products: main principles(Annex 2, WHO Technical Report Series 986,2014) Acti... Read more

DGFT guidelines for Barcoding as per GS1 Standards Pharmaceuticals

Posted By: Pharmaceutical Guidanaceon: March 28, 2016In: PresentationNo Comments

DGFT guidelines for BarcodingFor More Pharma Updates Visit http://pharmaguidances.com as per GS1 Standards Pharmaceutical For More Pharma Updates Visit –http://pharmaguidances.com Read more

Presentation on ICH Guideline

Posted By: Pharmaceutical Guidanaceon: March 26, 2016In: PresentationNo Comments

ICH Design Space Key Messages ICH Development ICH Inspection ICH Introduction to the new paradigm ICH Manufacturing Implementation ICH Pharma Quality System Key Messages ICH Control Strategy... Read more

Presentation on ICH Q9

Posted By: Pharmaceutical Guidanaceon: March 26, 2016In: PresentationNo Comments

ICH AssessmentI Q9 Basic Risk Management Facilitation Methods Q9 Combination of Tools Q9 Development Q9 Executive Summary CH Quality Risk Management Key Messages Q9 Facilities Equipement uti... Read more