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7.A Official requirements

ICH as equal partners, any ICH issued guidances can also be seen as important ref- erence documents (chapter E ICH-Guidelines and ICH homepage www.ich.org).

The US FDA Compliance Program Guidance Manual can also provide invalua- ble information about what can be expected by the FDA. These Compliance pro- grams were written for FDA personnel, and provide manufacturers with greater insight into what the FDA expects.

It is suggested that the FDA website should be searched for applicable inspection guides such as Program Numbers:

  • 7346.832 Pre-Approval Inspections/Investigations (see chapter D.17)

  • 7346.843 Post-Approval Audit Inspections

  • 7356.002 Drug Manufacturing Inspections, and

  • 7356.002A Sterile Drug Process Inspections

It is important to note that the United States Food and Drug Administration (FDA) has become a member of the PIC/S as of January 2011. As a result of this new membership, it is likely to see a greater impact of PIC/S upon FDA expectations whether or not such practices are officially acknowledged. Process Validation expectations and applications are likely to migrate into a more homogeneous application as inspectional findings are shared among PIC/S members.

Figure 7.A-1 gives an overview of relevant text passages in the regulations.

Regulations relating to process validation

Directive 2003/94/EC, article 10 §3

Validation of new manufacturing procedures and all important changes

EU Guidelines to Good Manufactur- ing Practice for Medicinal Products, chapter 5.22

When any new manufacturing formula or method of preparation is adopted, steps should be taken to demonstrate its suitability for rou- tine processing. The defined process, using the materials and equipment specified, should be shown to yield a product consistently of the re- quired quality.

Annex 15 of EU Guidelines to Good Manufacturing Practice for Medici- nal Products

Description of the validation process

PIC/S PI 006 “Recommendations on Validation Master Plan, Installation and Operational Qualification, Non- Sterile Process Validation, Cleaning Validation”

As interpretation and implementation aid for Annex 15 of the EU GMP Guideline


Figure 7.A-1

Regulations relating to process validation

M. Hiob / M. Lazar

GMP Manual (Up11) © Maas & Peither AG – GMP Publishing


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