FDA published a draft guidance for industry entitled “Request for Quality Metrics”

7 September 2015

On 28 July 2015, FDA published a draft guidance for industry entitled “Request for Quality Metrics”. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Quality metrics are used throughout the pharmaceutical industry to monitor

EMA published a Draft guideline on manufacture of the finished dosage form (Part I)

26 August 2015
bulk, control strategy, CTD, design space, finished product, GDP, intermediate, manufacture, process description, RTRT, storage, transport,

On 9 July 2015, EMA released for 6 months public consultation the Draft guideline on manufacture of the finished dosage form. It should be mentioned here, that the need to update and revise the CPMP/QWP/486/95 note for guidance on manufacture of the finished dosage form (current guideline) was originally presented in the document entitled Concept

Revision of the EU GMP Guide – Annex 15

12 May 2015

On 30 March 2015, the European Commission published revised version of Annex 15: Qualification and Validation of the EU GMP Guide. The new annex will become effective on 1 October 2015. Comparing to current version of the annex, extensive changes have been made in some areas. Particularly, it relates to Process Validation and Cleaning Validation.

ICH published a Final Concept Paper for a new ICH Q12 Guideline

25 February 2015
change management, chemistry, CMC, continual improvement, control, ICH Q12, knowledge management, lifecycle management, management of post-approval CMC changes, manufacturing, prospective change management,

Recently, ICH published a Final Concept Paper for a new ICH Q12 Guideline entitled “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management”. There is currently a lack of a harmonised approach on technical and regulatory considerations for product lifecycle management. While the concepts in ICH Q8, Q9, Q10 and Q11 provide opportunities for a

Active substance starting material(s) – importance of selection

4 December 2014
active substance, API, cell banks, cell substrate, GMP, ICH Q11, Master Cell Bank, MCB, redefinition, starting material, WCB, Working Cell Bank,

According to the Part II: Basic Requirements for Active Substances used as Starting Materials of the EU GMP Guide, the manufacturer should designate and document the rationale for the point at which production of the active substance begins. For synthetic processes, production of the active substance begins at the point at which “Active Substance Starting

Revision of the EU GMP Guide – Chapter 6

21 October 2014

On 28 March 2014, the European Commission published revised version of Chapter 6: Quality Control of the EU GMP Guide. The new chapter came into force on 1 October 2014. Special attention should be given to current point iv. of section 6.7 and section 6.9 relating to OOS and OOT results and also to newly

Revision of the EU GMP Guide – Chapter 8

7 October 2014

On 13 August 2014, the European Commission published revised version of Chapter 8: Complaints, Quality Defects and Product Recalls of the EU GMP Guide. The new chapter will become effective on 1 March 2015. Extensive changes have been made to this chapter and in practice, it has been revised completely. The principle: “In order to

Revision of the EU GMP Guide – Chapters 3 and 5

4 October 2014

On 13 August 2014, the European Commission published revised versions of Chapter 3: Premises and Equipment and Chapter 5: Production of the EU GMP Guide. The new chapters will become effective on 1 March 2015. Chapter 3: Premises and Equipment The revision concerns section 3.6 as part of the improved guidance on prevention of cross-contamination involving

Audits of the manufacturers and distributors of active substances – Legal basis

29 September 2014

According to an Article 46(f) of Directive 2001/83/EC as amended for medicinal products for human use, the holder of a manufacturing authorization shall at least be obliged: “to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances, which have been manufactured in accordance with