DOCUMENTATION AS AN INTEGRAL PART OF QUALITY ASSURANCE IN THE PHARMACEUTICAL INDUSTRY

Abstract

The basic rules in any Good Manufacturing Practice indicate that the drug manufacturer must keep
proper documentation and records. The documentation helps to build a detailed picture of the functioning of the
processes within the pharmaceutical industry, and thus provides a basis for planning improvements that will be
implemented in the future.
Good manufacturing practice (GMP), which is part of quality assurance, ensures that products are consistently
manufactured and controlled according to quality standards and according to their intended use. Good
manufacturing practice is primarily aimed at reducing risk when performing activities that are involved in
pharmaceutical production and control. Good manufacturing practice is a regulatory requirement.
Regulatory bodies during their inspections of production sites, often spend a large part of the inspection time in the
review of the documentation and records made by the manufacturer. Documentation provides the route for auditors
to assess the overall quality of operations within a company and the final product.
Effective documentation makes good visualization of the quality assurance system. Clearly written procedures
prevent errors resulting from spoken communication, and clear documentation permits tracing of activities
performed. Documents must be designed, prepared, reviewed, and distributed with care and must be approved,
signed, and dated by the appropriate competent and authorized persons.
Records must be kept at the time each action is taken and in such a way that all activities concerning the
development, production and the quality control of products are traceable. Storage of critical records must at secure
place, with access limited to authorized persons. The storage location must ensure adequate protection from loss,
destruction, or falsification, and from damage due to fire, water, etc.
Good Documentation Practice (GDocP) is a pharmaceutical industry term. Good Documentation is an integral part
of the Good Manufacturing Practice and it is essential for the integrity of data collection and reporting for
supporting development, registrations, commercialization, and life-cycle management of pharmaceutical products.
Documents are a mirror to show actual image of any pharmaceutical industry. Such measures that collectively and
individually ensure documentation, whether paper or electronic, is attributable, legible, traceable, permanent,
contemporaneously recorded, original and accurate.
‘If it’s not written down, then it didn’t happen!’