DOCUMENT GUIDELINES

Hello Everyone,

What guidelines do we need to follow in order to prepare QA Documents, Such as SOP’s , Self inspection, MFR’s, Protocols ( cleaning, process, equipment and method val.)

Awaiting for your valuable answers.

Please refer ICH Q9 guidelines on Quality Risk Management and ICH Q10 guidelines on Pharmaceutical Quality System to understand quality requirements of pharmaceutical products throughout its life cycle.

The goals of manufacturing activities include achieving product realization, establishing and
maintaining a state of control, and facilitating continual improvement. The pharmaceutical
quality system should assure that the desired product quality is routinely met, suitable process
performance is achieved, the set of controls are appropriate, improvement opportunities are
identified and evaluated, and the body of knowledge is continually expanded.

Pharmaceutical Quality System Elements include following aspects,
The elements described below might be required in part under regional GMP regulations.
However, the Q10 model’s intent is to enhance these elements to promote the lifecycle approach
to product quality.

These four elements are:
• Process performance and product quality monitoring system
• Corrective action and preventive action (CAPA) system
• Change management system
• Management review of process performance and product quality
These elements should be applied in a manner that is appropriate and proportionate to each of the
product lifecycle stages, recognizing the differences among the stages and the different goals of
each stage. Throughout the product lifecycle, companies are encouraged to evaluate
opportunities for innovative approaches to improve product quality.

International Conference on Harmonisation (ICH) guideline Q9, Quality Risk Management, represents the first internationally recognized guideline specifically addressing QRM for the pharmaceutical and biopharmaceutical industries. Published in June 2005, the guideline offers an overview of general quality risk management principles, an example of a risk management life cycle, discussion around the activities that occur in each life cycle phase, and a list of risk tools and quality system areas to which QRM can be applied.