Types of Pharmaceutical Documentation

Five Basic types of documents will be described in the monograph, and key requirements for each will be outlined.


1. Policy Documents


Policy Documents give the company overview of what will be done, who is accountable for ensuring it is done, and company organisation to aid continuing with policy.


2. Specifications


Specifications are documents which describe starting materials, packaging materials, intermediate, bulk or finished product in terms of their chemical, physical and when appropriate biological characteristics. A specification normally includes descriptive clauses and numerical clauses and numerical clauses, which define standards and permitted tolerances.


3. Procedures


Procedures are formal written instructions which detail how an operation is to be performed. They are requires for all operation which can effect the safety, identity, quality and purity standards of medicinal products. Such documents are often termed 'SOPs' or Standard Operating Procedures.


4. Work Instructions


Work Instructions are batch- related documents which list all the starting materials to be used and the production operation.


5. Records


Records are completed documents, reports, instructions, protocols, logbooks etc., which are used to record information. They provide a history of each batch of product together with data pertinent to the quality of the final product.