DOCUMENTATION TYPES & GUIDELINES

ü  Standard operating procedures, specifications and master formulae

Descriptive documents give instructions on how to perform a procedure or a study, or

give a description of specifications. The instruction type documents are: standard

operating procedures (SOP); protocols (for validation studies, stability studies, safety

studies); and master formulae (manufacturing instructions). Each of these gives instruction

on how to perform specific procedures. Specifications describe the required

characteristics or composition of a product or material or test. These kinds of documents

provide the specific details defining the quality of incoming materials, the quality

of the production environment, the quality of the production and control process,

and the quality of the final product.

ü  Forms for recording data

Another type of documentation is the form used for recording data as it is taken during

the performance of tasks, tests, or events. These are forms (datasheets, or data

record forms), reports, batch processing records, and equipment log books. These

documents provide the evidence that the raw materials, facility environment, the production

process, and the final product consistently meet the established quality requirements.

ü  Identification numbers

There are also the identification systems or codes devised to number and track both

information and documents. These are SOP numbers, equipment numbers, form numbers,

receiving codes, and batch/lot numbers. These numbering systems should be

designed so that procedures, processes and materials can be traced throughout the data

records.

ü  Labels

Labelling systems are used to identify the status of the equipment or facility, restricted

areas, and warning labels. These include raw material tags, quarantine labels, release

labels, reject labels, labels to identify specific storage areas, biohazard or radioactive

labels, restricted access labels, equipment "cleaned" or "waiting for cleaning" labels,

process intermediate labels, and the final product labels. These permit the identification

and tracking of materials, of the progress of a production process, and assurance

of the proper functioning of equipment.

The WHO guidelines for Good Manufacturing Practices (ref. 21, 27) and all other

national and international GMP Guidelines and Regulations (ref. 3, 5, 7, 11, 18, 19)

emphasize the requirement for complete documentation. A well-structured documentation

system, including SOPs for the regular document review and revision, provides

the structure for recording the evidence for the quality of the product.

All documentation must be organized into files which must be maintained for specified

periods of time after the expiry date of the product.

A well-designed documentation system is useful only if it is well used. The system

must include quality assurance procedures to ensure that instructions are followed,

that labels and numbering systems are properly used and recorded, and that data record

forms and batch processing records are assembled and reviewed. Control and assessment

of the documentation system itself is a significant management tool that permits

an ongoing assessment of the changes and revisions necessary to remain in compliance,

to delete what is unnecessary or redundant and to improve procedures or processes.

Ref: WHO/VSQ/97.01 11