GMP Documentation - Documents, Records, Data Integrity and their definition and Classification
GMP Documentation
All GMP (Good Manufacturing Practices) documents shall be
accurate, truthful and complete, readily retrievable and traceable. All entries
shall be concise, legible, unambiguous and accurate.
Document
A document is a digital (Computer generated means which we cannot touch say Soft
Copy) or physical (which we can touch say Hard Copy) representation of a body
of information designed with the capacity to communicate with peoples (persons
which take information from these documents). A document may clear symbolic, pictorial
or sensory-representational information.
Instruction Document
A document which gives general or specific instruction on how to
perform certain activities.
Master Document
An approved set of instructions which can be replicated to issue
controlled operational copies.
Record
Any document which contains recorded evidence of an activity done during
manufacturing, testing and release of a product. The records could be hand
written or electronically generated.
Raw Data
Any worksheets, memorandum, notes, or exact copies thereof, which are the
result of original observations and activities. This also includes photographs,
microfilm or microfiche copies, computer printouts, magnetic media and recorded
data from automated instruments.
Electronic Record
A combination of text, graphics, data, audio, pictorial or other
information represented in digital form that are created, modified, maintained,
archived, retrieved or distributed by a computer system.
Data Integrity
The representational faithfulness of information to the true state
of the object that the information represents, where representational
faithfulness is composed of three essential qualities or core attributes:
accuracy, truthfulness and completeness.
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