Total Pageviews

Friday, 20 January 2012


1. New FDA Guidances

2. FDA Issues New PDF Specifications

USFDA guidelines, GMP guidelines, WHO guidelines, Schedule M, FDA, European guidelines cleaning validation, process validation, water system validation, ICH guidelines, GMP audut compliance, equipment qualification, Installation Qualification, Operational Qualification, Performance Qualification, Calibration, Validation Protocol, SOPs etc.

FDA Guidelines GMP Guidelines Pharmaceutical Validation Pharma Process Validations 21 CFR Part 11 compliance Clinical Trials FDA GMP Guidelines Good Manufacturing Practices Pharmaceutical Companies Pharmaceutical Industry FDA Guide Pharma Regulatory Affairs In Pharmaceuticals SOP'S Pharmacy Requirements of,Manufacturing,Documentation,Quality Assurance|SOP'S For Microbiology Department In Pharma Manufacturing Firm Questions and Answers WHO Sterile,Aseptic Process Training,Sterile Dosage Form.

5. Pharmaceutical cGMPS for the 21st Century — A Risk-Based Approach: Second Progress Report and Implementation Plan:

6. ICH Q11: relevant to the preparation and organisation of the contents of sections 3.2.S.2.2 – 3.2.S.2.6 of Module 3.

7. ICH Q10: This guideline applies to the systems supporting the development and manufacture of pharmaceutical drug substances (i.e., API) and drug products, including biotechnology and biological products,
throughout the product lifecycle. The elements of ICH Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognising the differences among, and the different goals of each stage, i.e., continual improvement of process performance and product quality (This is section 3 of Q10 which describes the lifecycle stage goals and the four specific pharmaceutical quality system elements that augment regional requirements to achieve the ICH Q10 objectives, as defined in Section 1.5. It does not restate all regional GMP requirements).
Section 1.5 of ICH Q10 is about meeting Q10's three objectives to complement or enhance regional GMP requirements. The three objectives are: 1. Achieve product realisation, 2. Establish and maintain a state of control, 3. Facilitate continual improvment.

8. ICH 9 - Quality Risk Management
Briefing pack - Annex-1  

Recommended Reading1. ICH, Q9 Quality risk management, 2006, ICH,
2. GAMP 5 Good Automated Manufacturing Practice (GAMP) Guide for A Risk-Based Approach to Compliant GxP Computerized Systems, February 2008, International Society for Pharmaceutical Engineering (ISPE), Fifth Edition, ISBN 1-931879-61-3,
3. GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures, 2005, International Society for Pharmaceutical Engineering (ISPE), First Edition, ISBN 1-931879-38-9,
4. ISO 14971:2007 Medical devices -- Application of risk management to medical devices, 2007, ISO,
5. Jones, A. and Ashenden, D., Risk Management for Computer Security: Protecting Your Network & Information Assets, 2005, Elsevier, ISBN 0-7506 7795 3
6. Kumamoto H. and Henley, E.J., Probabilistic Risk Assessment and Management for Engineers and Scientists, 1996, Institute of Electrical and Electronics Engineers, Inc., New York, NY, USA,
ISBN 0-7803-6017-6

This page provides information about the electronic submission of regulatory information to the Center and the review of it by CDER staff. Additional guidance documents, when available in draft or final form, will be added to these pages.
11. Electronic Common Technical Document (eCTD): Source: FDA

eCTD Basics and Getting Started

The Electronic Common Technical Document (eCTD) is CDER/CBER’s standard format for electronic regulatory submissions. The FDA would like to work closely with people who plan to provide a submission using the eCTD specifications and we offer the following steps to help smooth the process.
Understand the Various Tools, Software and Training Opportunities
FDA as a government agency does not recommend specific software or tools. Information on tools, vendors, and eCTD preparation firms may be obtained by Internet search. We recommend that you choose eCTD software and tools that allow you to build, validate, and view an eCTD.
In addition, there are several non-profit organizations that sponsor conferences and offer training in eCTD, and FDA regularly participates in these events.
Submit a Sample eCTD to the FDA
Your first step after following the recommendations above would be to submit a sample eCTD for evaluation. For information on the process of submitting a sample, please refer to the Sample Submission Process.

Build Quality into Your Process to Ensure Success
  • Plan and prepare early for electronic submission
  • Build a knowledge base to understand the electronic submission process and clarify any questions you have on guidance documents
  • Ask CROs in advance to provide reports in searchable PDF format compliant with the ICH M4 Granularity Annex and FDA PDF Specification
  • Utilize a procedure to verify that your submission is complete and accurate
  • Don’t rush when submitting, since what can seem like a small error can have big implications (such as a wrong digit in your application number)
  • Take advantage of the Electronic Submissions Gateway and use FDA fillable forms and digital signatures for the fastest processing of your electronic submissions
It’s important to both view and validate your eCTD submission prior to submitting; see the eCTD validation specifications for more information. Review the most recent eCTD presentations by FDA staff so you’re aware of current recommendations. 
If you have questions along the way, please do not hesitate to contact the CDER Electronic Submission (CDER ESUB) Support Team at

 eCTD Guidance and Specifications

Guidance Documents
eCTD Specifications