• gmp-verlag.de
  • GMP MANUAL Login
  • Shopping cart
Stay informed!

You’d like to be regularly informed on the latest developments in Good Manufacturing Practices?

 

Subscribe to our free GMP Newsletter LOGFILE!

>>> REGISTER NOW

The New USP <1231>
Water for Pharmaceutical Purposes

a detailed Overview

>>> ORDER NOW

Award for the
GMP MANUAL

GMP knowledge that convinces.

Image

On 7 June 2016 Maas & Peither GMP Publishing has received a

SIPAward in the category
"Best New Success Story" and was awarded with the 3rd place.

The GMP MANUAL impressed the jury with "Save Drugs through Better GMP Understanding".


GMP MANUAL

GMP in Practice: 24 chapters written by internationally renowned industry experts.

 

GMP Regulations: 8 chapters with the most important GMP guidelines and regulations.

 

Image

>>> READ MORE

TOP 5 GMP Downloads

1. GMP Fundamentals
A quick and comprehensive overview of the complex world of GMP.

 

2. GDP Audit Checklist

More than 700 questions with reference to regulations.

 

3. How to design a Laboratory Data Management System
Practical strategies for designing and implementing an LDMS.


4. Industry Guide to handle OOX Test Results
A concise overview of the OOX process.

 

5. GMP Compliance Basics of Packaging Materials and Processes
Are you on top of the best practices you need to design and create your packaging correctly — every time?

 

>>> More Downloads

News about GMP/cGMP

EMA: Pilot Batch Size - Process Control

"When validating a manufacturing process, if a common bulk is used to manufacture a series of products, how should the pilot batch size be decided upon?" The answer to this question is provided by EMAs Quality Work Party in their Questions & Answers List.

 

The answer of EMAs Quality Working Party says, it is the applicant’s responsibility to select and justify the pilot batch size.

The joint CHMP and CVMP guideline on process validation (CPMP/QWP/848/96, CVMP/598/99) states that: “pilot-batch size should correspond to at least 10% of the future industrial scale batch i.e. such that the multiplication factor for scale-up does not exceed 10. For oral solid dosage forms this size should be at least 10% or 100,000 units whichever is greater* unless otherwise justified”.

The guideline does not dictate that the 10% figure should always be linked to the scale of manufacture of individual product presentations. In addition, it allows for departures from the guidance where this is justified. Further, the guideline does not preclude the use of bracketing.

Certain bulk products are used to produce a series of presentations, for example a bulk powder blend may be used to produce 50 mg, 100mg and 200 mg direct compression tablets with the same percentage composition. In such instances, as long as the applicant can demonstrate a satisfactory link between the pilot batch size used for validation and the routine production batch size, it will usually be acceptable to define the pilot batch size as 10% of the planned production scale for the bulk product. During the process validation study, the complete pilot scale bulk batch should be used to manufacture the individual presentations. The division of the bulk batch between the different presentations should also be justified.

*In the case of veterinary medicinal products, the minimum pilot size may be smaller than 100,000 units where justified.

Outcome:

Check your batch size to verify if it is (still) reasonable!

Links:

EMA/ Q & A List

EMA/ Q & A Batch Size

Comments
No comment has yet been written about this news.