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Inspection of Active Pharmaceutical Ingredients: Aide-Memoire
Inspection of Active Pharmaceutical Ingredients: Aide-Memoire
PI 030-1
13 January 2009
AIDE-MEMOIRE
INSPECTION OF ACTIVE
PHARMACEUTICAL INGREDIENTS
e-mail: info@picscheme.org
web site: http://www.picscheme.org
Page
1. DOCUMENT HISTORY
2. INTRODUCTION
2.1 The adoption of ICH Q7 as the first truly harmonised GMP guideline for active
pharmaceutical ingredients (APIs) and the associated development of
regulatory frameworks to implement the guideline as a regulatory standard
mark the beginning of a new era of regulation for medicines.
2.2 The adoption of ICH Q7 by PIC/S occurred in May 2001 with the current version
of the guideline having been available since 1 September 2007 as GMP
PE 009 (Part II).
2.3 The primary objective for implementing ICH Q7 is the reduction of the risks
associated with the manufacturing quality of APIs and this cannot be achieved
without an effective inspection system which addresses the specific aspects of
the global API industry.
3. PURPOSE
3.1 It is recognised that due to their background and experience the majority of
GMP inspectors are more familiar with the inspection of finished products.
Therefore, to assist inspectors not specialised in the inspection of API
manufacturers this document has been developed to provide training and
guidance for the preparation and performance of such inspections.
4. SCOPE
4.1 At the time of issue, this document reflected the current state of the art. It is not
intended to be a barrier to technical innovation or the pursuit of excellence.
___________
3. Personnel
Area of
Supporting
operations / Notes Crucial questions/Show me
documents
items
Cf. Scope 4.2 3.
5. Process equipment
Area of
Supporting
operations / Notes Crucial questions/Show me
documents
items
This section is to be 5.
developed at the next
revision of the Aide-
Memoire
7. Materials management
Area of
Supporting
operations / Notes Crucial questions/Show me
documents
items
Suppliers Critical materials and Have supplier control procedures 7.11
qualification their suppliers been defined and implemented?
12. Validation
Area of Notes Crucial questions/Show me Supporting
operations / documents
items
Validation Is the company's validation policy 12.10, 12.11
Policy documented?
Are all critical manufacturing steps 12.12
validated?
Validation Validation protocol Is the validation protocol compliant 12.20
Documentation established and with the company’s validation policy?
approved by the Quality
Unit
Critical steps that Has the rationale for identifying 12.21
require validation and certain manufacturing steps and
acceptance criteria operating parameters as critical, been
specified documented?
6. REVISION HISTORY
Version
Date Reasons for revision
number
Bibliography:
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