ICH Q7 guidelines

What is ICH Q7?

The ICH Q7 is a globally harmonized GMP guideline for Active Pharmaceutical Ingredients (API). This guideline covers all GMP aspects of manufacturing, quality control and trading of both chemical and biological ingredients of a drug.

When did it come into effect?

The ICH Q7 was arrived at by the International Conference of Harmonization (ICH), which is why it gets its name. Adapted in November 2000, it came into being after three of the world’s leading medical device markets, namely the EU, Japan and the US agreed to it.

Important sections for day-to-day implementation

Although a comprehensive guideline that covers almost all aspects of GMP for API in its 19 section; a few sections are more important than the rest. It makes sense to be aware of these sections and implement them for day-to-day use.

  1. Introduction and glossary: Most people only glance at this section and its sub-sections, but it contains very important details. For instance, it contains unique definitions, especially those on API starting materials and manufacturing. Unique definitions by experts are carried here. They help to properly apply the intent of ICH Q7.
  2. Buildings and facilities: Extremely important because it contains reference to minimum quality of potable water, closed systems and contact utilities.
  3. Process equipment and cleaning: This states that contact surfaces of all materials should not be able to alter the quality of the product or the material beyond stated or established requirements.
  4. Production and inprocess controls: This section is vital because it states that deviations need to be documented under API GMP.
  5. Process Validation: Undoubtedly the most critical section of GMP, because this is what qualifies and validates a process. It also carries important issues such as qualification vs. validation.
  6. Rejection and reuse of materials: ICH Q7 is perhaps the only document that precisely defines these terms. But for this, there would be considerable confusion about what we would be doing under API GMP.
  7. Agents: Outcome of the Haitian situation in the mid-1990’s, where children died from glycerube contamination; this requires maintenance and traceability of records and processes from manufacturer to user.


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