Q7 Q&As - Quality Guidelines : ICH

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Q7 Q&As - Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Follow this link to the Q7 section: Q7 Q&As - Quality Guidelines : ICH:

"Experience gained with the implementation of the ICH Q7 Guideline since its finalisation in 2000 shows that uncertainties related to the interpretation of some sections exist. Technical issues with regard to GMP of APIs – also in context with new ICH Guidelines - are addressed in this Question and Answer document in order to harmonise expectations during inspections, to remove ambiguities and uncertainties and also to harmonise the inspections of both small molecules and biotech APIs."

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ICH Photosafety - FDA EU Draft Guidance

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Updated December 23, 2021

ICH Photosafety Guidance Aims to Bridge FDA, EU Differences:

"The FDA and Health Canada recently opened for industry comment new guidance from the International Conference on Harmonisation  on the photosafety testing of drug compounds.

“The S10 draft guidance document clarifies some points in the current EMA and FDA guidance that are known weaknesses, based on accumulated information and experience since those documents were issued in the mid-2000s,” Doug Learn, director of photobiology at Charles River, told In-Pharmatechnologist.com."

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Read the guidance (updated link):

PHOTOSAFETY EVALUATION OF PHARMACEUTICALS - S10 (pdf) 

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ICH Q11 Reaches Harmonization, Implementation is Next

PharmTech Talk » ICH Q11 Reaches Harmonization, Implementation is Next:

"ICH Q11, the anticipated guideline from the International Conference on Harmonization (ICH) titled Development and Manufacture of Drug Substances, has achieved international consensus. Q11 has been one of the fastest guidelines to move through the ICH harmonization process. Q11 was published as a draft in May 2011 and reached Step 4 this month, which means that the ICH steering committee members (representing regulatory and trade organizations in the US, Europe, and Japan), have reached scientific consensus and signed the guideline. At this point, each of the region’s regulatory agencies, including FDA, will publish the guideline as official guidance within their appropriate regions and implementation will begin."

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An Alternative To The Free Online GCP Training by Quintiles

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Free Online GCP Training

Updated 4/10/2015:

The Quintiles GCP training is no longer available to the public for free.

I recently discovered a free, publicly accessible GCP training program that might be of interest to you: The Good Clinical Practice (GCP) course, offered by the National Drug Abuse Treatment Clinical Trials Network

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Free Online GCP Training | Clinical Research Learning Blog:  'via Blog this'

Upon completion of the program the participant will be able to:

1. Describe the ICH Good Clinical Practice (GCP) and local regulatory guidelines for good clinical practice in the conduct of clinical trials 
2. Discuss the investigator’s responsibilities in the conduct of clinical trials at the clinical site 
3. Apply ICH and local regulations to specific research activities at the clinical site

Free is good!

Quintiles helps pharmaceutical, biotechnology and medical device companies develop and market innovative therapies. Quintiles is also a full sized CRO and has its operations over more than 40 countries world wide.  

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ICH Celebrates 20th Anniversary - Refreshes Website

Congratulations to The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) as they celebrate their 20th anniversary.

The ICH website has been redesigned for better usability and sports new branding.

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You might also be interested in:
International Conference on Harmonisation (ICH) Quality Guidelines: Pharmaceutical, Biologics, and Medical Device Guidance Documents Concise Reference

FDA Guidance On ICH Q8-10

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This FDA guidance, FDA - Guidance for Industry - Q8, Q9, and Q10 - Questions and Answers, reflects the current working procedure of the ICH Quality Implementation Working Group (Q-IWG) for implementing the Q8, Q9, and Q10 guidances.

The guidance, in Q & A format covers:

• Q8 (R2) Pharmaceutical Development (includes the Q8 parent guidance (Part I) and the annex (Part II), which provides further clarification of the Q8 parent guidance and describes the principles of quality by design)
• Q9 Quality Risk Management
• Q10 Pharmaceutical Quality Systems

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FDA Final Guidance On ICH Q10 - Quality Control System

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If you follow quality issues in the GMP regulated industry space, you'll want to get up to speed on ICH Q10. Here's what the FDA has to say about this new guidance, FDA - Q10 Pharmaceutical Quality System:

This internationally harmonized guidance is intended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system. Throughout this guidance, the term pharmaceutical quality system refers to the ICH Q10 model. ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) quality concepts, includes applicable good manufacturing practice (GMP) regulations, and complements ICH "Q8 Pharmaceutical Development" and ICH "Q9 Quality Risk Management." ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle. Much of the content of ICH Q10 applicable to manufacturing sites is currently specified by regional GMP requirements. ICH Q10 is not intended to create any new expectations beyond current regulatory requirements. Consequently, the content of ICH Q10 that is additional to current regional GMP requirements is optional.

In summary, the International Conference on Harmonization's (ICH) Q10 attempts to provide a comprehensive model for an effective quality management system by building upon good manufacturing practices (GMP). 

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FDA Releases Revision To Q8 Pharmaceutical Development Guidance

The FDA released this guidance revision, Guidance for Industry Q8(R1) Pharmaceutical Development, which is a revision of the ICH guidance Q8 Pharmaceutical Development (Q8 parent guidance) that was published in May 2006. The Q8 parent guidance is revised to add an annex, which provides further clarification of the key concepts outlined in the May 2006 guidance and describes the principles of quality by design (QbD). This Q8(R1) document includes the Q8 parent guidance and the annex. This guidance is intended to provide guidance on the contents of section 3.2.P.2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use). 

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Free GMP Glossary

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Updated September 25, 2020

The link in the original post broke.

I offer you this alternative link instead:
Terminology & Definitions in Pharmaceuticals - Pharmaceutical Guidelines

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I'm continually amazed at all the fabulous free GMP resources that can be found on the web. Take a look at this GMP Glossary made available by the Maas & Peither GMP Publishing Team. This team's description, "Definitions of GMP terms derived from EU, FDA and ICH guidelines are the base of your GMP communication and documentation."

They're right. Not only can your communication and documentation be made more precise, you can use this glossary for your GMP training efforts and classroom training.

Previous posts on FDA GMP training:

1. The Health, Drug, Prescription, and GMP Supersite: 4 Free Articles on GMP Training
2. The Health, Drug, Prescription, and GMP Supersite: Free GMP Training Tip - Your Homework Is To Sleep Before Class
3. The Health, Drug, Prescription, and GMP Supersite: 2 Free GMP Training Tips - Make It Fun!

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