DOCUMENTATION TERMS USED IN MANUFACTURING

OF PHARMACEUTICAL PRODUCTS

Quality Manual - a detailed document that sets forth practices and sequences of activities aimed
at translating organizations quality policy into operational results or
conformance to standards such as ISO 9000 series.

Quality Procedures - it documents the methods employed to achieve the policy defined in the QSM.
- A procedure that defines how the production department will achieve the
objectives. It includes quality manual of central documents and records.

Supporting documents - written information attached to agreements, financial statements, offers,

proposals to provide back up and depth to agreed upon or discussed items.
( supporting data/ supporting schedule )

Quality Records - documents recording specific information. Relating to a procedure or work

instructions.
- Proof that an organization is complying with its procedures and policies
- Used to provide trace abilities of actions taken on specific product or batch
of products

Master Formula - it is the original document used as a key in the production of products. It
assures identical reproduction of the product document

Batch Processing Record - is a batch and product document designed to give a complete and
reliable picture of the manufacturing history of each batch of every product.
- It should be prepared for each batch of drug products processed and
should include complete information relating to a production and control of
each batch. It includes the accurate reproduction of appropriate master
control production record, checked of accuracy, date and signed.

Batch Packaging Record - records containing all information relating to packaging instructions and
operation of each batch.
- It includes the name of the product, the date and time of packaging
operations, the name of the responsible person carrying out of the
packaging operation. The initials of the operation records of checks for
identity and conformity with packaging instructions including the result of
in process controls , details of packaging operation carried out.

Standard Operation Procedures - involves step by step process in performing task

Working Instructions - description of specific tasks and activities within an organization

Machine and Material Specification - detailed description or assessment of requirements, dimensions

of materials