PHARMACEUTICAL MANUFACTURING

DOCUMENTATION
Documentation is an integral part of good manufacturing practices.
It defines a system of information and control so that risks so
inherent in misinterpretation and/or error in oral communication are
minimized.
It consequently strengthens the quality, and its consistency, of all
goods and services, as those responsible for the specific operations
have clear, unambiguous instructions to follow including active drug
substances, is legally mandatory. (OPPI Guideline)
OBJECTIVES OF DOCUMENTS
1.      To define the specifications and procedures for all materials
and method of manufactured and control.
2.      To ensure that all personal concern with manufacture know
what to do and when to do it.
3.      To ensure that authorized persons have all the information
necessary to decide whether or not to realize a batch of a drug for
sale.
4.      To ensure the existence of documented evidence, trace
ability, and to provide records and an audit trail that will permit
investigation.
5.      It ensures the availability of the data needed for validation,
review and statistical analysis.

IMPORTANCE IS WRITTEN