Professional Documents
Culture Documents
Training Workshop on
Pharmaceutical Development with
focus on Paediatric Formulations
Protea Hotel
Victoria Junction, Waterfront
Cape Town, South Africa
Date: 16 to 20 April 2007
Email: susanw@netspeed.com.au
Now:
We will:
“Quality:
The suitability of either a drug substance [=API] or drug
product [=FPP] for its intended purpose”
ICH Q6A (1999)
Some of the elements of FPP quality:
Meets suitable criteria for content of active(s)
The product:
Is reproducible from batch to batch in terms of all characteristics
that may affect the patient
Has container labelling & prescribing information that is clear,
contains all the necessary information, & accurately represents
the FPP’s efficacy & safety profile
For FPPs containing new APIs: Has the same efficacy & safety
profile as the batches used in pivotal clinical studies
For generics: Has the same plasma concentration/time profile as
the innovator whose efficacy & safety profile is known
Some terminology
• Guidelines
• WHO PQP
• Especially p16/26 Control of the FPP
• ICH
• Technically ICH guidelines apply only to new APIs. In practice
regulators apply them more widely (eg PQP)
From ICH’s early days, there have been working groups that focussed on
harmonisation of pharmacopoeial requirements among the three ICH regions
But to date no harmonised monographs have been published on the ICH
website
These are the three relevant topics that appear on the ICH website
– Q4 Pharmacopoeias
– Q4A Pharmacopoeial Harmonisation
– Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria
(RAAPAC)
Of these, only Q4B has published a draft consensus guideline. It deals with
bureaucratic processing of documentation.
– Keep an eye on the ICH website for updates
– Repeatability
• Within & between equipment, analysts, labs etc
• Over time (eg this year vs next year)
– Discriminatory power
• Discriminates between batches that perform well in
vivo & those that do not
– Apparatus
– Medium (solvent)
– Sampling times
– Acceptance criteria
Prefer:
– Profiles (multipoint) vs one or two point tests
• Profiles are more discrimating than one or two point tests
• Formulation comparisons should normally be profiles
• One or two point tests may be adequate for routine batch release if fully
justified
• ‘Rapidly dissolving’
≥ 85% in 30 minutes